Background: Veterans with HIV/AIDS (VWH) frequently report alcohol misuse, which can impact antiretroviral therapy (ART) adherence and lead to poorer clinical outcomes. The TRAC (Tracking and Reducing Alcohol Consumption) intervention was developed to help VWH reduce alcohol use and its associated consequences. TRAC is delivered via mobile device, incorporates eight counseling sessions based in cognitive behavioral therapy and motivational interviewing, and utilizes mobile surveys and breathalyzers for daily monitoring of alcohol and ART use.
Methods: We conducted a pilot randomized waitlist-controlled trial (N = 50). Participants were allocated to an immediate intervention group (N = 26), which received the TRAC intervention and completed twice-daily monitoring of alcohol and ART use for 8 weeks, or to a waitlist-control (n = 24), which started TRAC after 8 weeks. Participants provided ratings of intervention sessions and completed questionnaires assessing alcohol use, ART adherence, and treatment self-efficacy at baseline, 8, 16, and 24 weeks. Analyses included correlations and descriptive statistics for examining feasibility and acceptability, difference-in-differences analyses to compare changes between groups at the 8-week timepoint, matched pair tests to assess changes in alcohol use during the intervention, and general linear models to investigate long-term effects on outcomes with a pooled sample.
Results: Results indicated high feasibility and acceptability: 84% of participants were retained through the intervention and all follow-ups, average intervention session ratings were 9.6 (out of 10), and participants completed a median of 85% and 78% of mobile surveys and breathalyzer readings, respectively. While not statistically significant due to low power, there was a trend of decreased binge drinking episodes and fewer missed HIV medication doses in the intervention group compared to control. When pooling data among participants from both groups to examine long-term effects, TRAC was associated with reductions in several drinking-related outcomes.
Conclusions: High acceptability and feasibility, as well as preliminary evidence that the intervention may reduce alcohol use relative to control, suggest that the TRAC intervention is promising for VWH and warrants further evaluation in a randomized controlled trial with adequate power to detect effects. If shown to be efficacious, TRAC has potential to be a highly scalable and acceptable intervention for delivery among VWH.
Trial registration: This study was registered on ClinicalTrials.gov, #NCT03746600. Registration date: 09/24/2018.
{"title":"The tracking and reducing alcohol consumption (TRAC) intervention for veterans living with HIV/AIDS: results from a pilot randomized waitlist-controlled trial.","authors":"Carolyn Lauckner, Reuben Adatorwovor, Erica Taylor, Fidelis Sesenu, Tehquin Tanner, Alexis Whitmire, Vincent Marconi, Trace Kershaw, Nathan Hansen","doi":"10.1186/s13722-025-00631-5","DOIUrl":"10.1186/s13722-025-00631-5","url":null,"abstract":"<p><strong>Background: </strong>Veterans with HIV/AIDS (VWH) frequently report alcohol misuse, which can impact antiretroviral therapy (ART) adherence and lead to poorer clinical outcomes. The TRAC (Tracking and Reducing Alcohol Consumption) intervention was developed to help VWH reduce alcohol use and its associated consequences. TRAC is delivered via mobile device, incorporates eight counseling sessions based in cognitive behavioral therapy and motivational interviewing, and utilizes mobile surveys and breathalyzers for daily monitoring of alcohol and ART use.</p><p><strong>Methods: </strong>We conducted a pilot randomized waitlist-controlled trial (N = 50). Participants were allocated to an immediate intervention group (N = 26), which received the TRAC intervention and completed twice-daily monitoring of alcohol and ART use for 8 weeks, or to a waitlist-control (n = 24), which started TRAC after 8 weeks. Participants provided ratings of intervention sessions and completed questionnaires assessing alcohol use, ART adherence, and treatment self-efficacy at baseline, 8, 16, and 24 weeks. Analyses included correlations and descriptive statistics for examining feasibility and acceptability, difference-in-differences analyses to compare changes between groups at the 8-week timepoint, matched pair tests to assess changes in alcohol use during the intervention, and general linear models to investigate long-term effects on outcomes with a pooled sample.</p><p><strong>Results: </strong>Results indicated high feasibility and acceptability: 84% of participants were retained through the intervention and all follow-ups, average intervention session ratings were 9.6 (out of 10), and participants completed a median of 85% and 78% of mobile surveys and breathalyzer readings, respectively. While not statistically significant due to low power, there was a trend of decreased binge drinking episodes and fewer missed HIV medication doses in the intervention group compared to control. When pooling data among participants from both groups to examine long-term effects, TRAC was associated with reductions in several drinking-related outcomes.</p><p><strong>Conclusions: </strong>High acceptability and feasibility, as well as preliminary evidence that the intervention may reduce alcohol use relative to control, suggest that the TRAC intervention is promising for VWH and warrants further evaluation in a randomized controlled trial with adequate power to detect effects. If shown to be efficacious, TRAC has potential to be a highly scalable and acceptable intervention for delivery among VWH.</p><p><strong>Trial registration: </strong>This study was registered on ClinicalTrials.gov, #NCT03746600. Registration date: 09/24/2018.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":" ","pages":"1"},"PeriodicalIF":3.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12781520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145670659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-02DOI: 10.1186/s13722-025-00627-1
Natalie Stahl, Amy Bositis, Carolyn Damato-MacPherson, Rebecca Weiner, Dianna Conole, Ann Scheck McAlearney, Henry M Stadler, Avik Chatterjee
{"title":"Expedited referrals from community health center to opioid treatment program: innovative approaches to improving access to methadone treatment for patients who use opioids and experience homelessness.","authors":"Natalie Stahl, Amy Bositis, Carolyn Damato-MacPherson, Rebecca Weiner, Dianna Conole, Ann Scheck McAlearney, Henry M Stadler, Avik Chatterjee","doi":"10.1186/s13722-025-00627-1","DOIUrl":"10.1186/s13722-025-00627-1","url":null,"abstract":"","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":" ","pages":"94"},"PeriodicalIF":3.2,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12673686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145662030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-02DOI: 10.1186/s13722-025-00615-5
Aleena Varghese, Rebecca Amanda, Julie Ayre, Kaniz Fatema, Andrew Miles, Gilbert Whitton, Mythily Subramaniam, Amit Arora
Background: The utilisation of online evidence-based written educational resources is crucial in addressing problematic alcohol and other drugs (AOD) use through prevention, treatment, and intervention strategies. However, low health literacy among one in five Australian adults raises concerns regarding the effective understanding of health information. This study aims to evaluate the content, suitability, and readability of AOD resources in New South Wales (Australia), recognising the importance of accessible and informative resources in supporting AOD demand reduction strategies.
Methods: In this research, a comprehensive desktop search was conducted to analyse one to two-page AOD resources readily accessible through the internet in New South Wales, published by government and not-for-profit organisations. The content was thoroughly analysed for its coverage of key AOD topics. The Suitability Assessment of Materials (SAM) instrument evaluated visual and written elements, examining aspects like layout, typography, and illustrations. Readability was assessed using Flesch -Kincaid Grade Level (FKGL), Gunning Fog Index (FOG), Simplified Measure of Gobbledygook (SMOG), and Flesch Reading Ease tools. Descriptive statistics, including frequency, percentage, and standard deviation were calculated.
Results: The study analysed 88 AOD resources. Most resources had a target audience, but only three resources involved consumers in the development process. The content analysis showed 66% focused on drug-related topics, 20% on alcohol-related topics, and 14% covered both. Topics such as alcohol use during pregnancy and breastfeeding were well addressed in alcohol resources. Additionally, 90% of the resources had headings and subheadings. However, only 28% scored 'superior' for layout, and none achieved 'superior' ratings for typography. Furthermore, 74% did not use illustrations to highlight key messages. Most resources used an active voice and conversational style, but complex sentences were common. The average reading grade level of the resources was 9 ± 2.6 with FOG and Flesch's reading ease indicating 10th-grade difficulty, while FKGL and SMOG suggested a 7th-grade level.
Conclusions: The evidence strongly suggests the need for the development of AOD resources that are accessible to individuals with low literacy levels without sacrificing content coverage. A key recommendation is to involve consumers in both developing and reviewing these resources.
背景:利用基于证据的在线书面教育资源,通过预防、治疗和干预策略来解决酒精和其他药物(AOD)使用问题至关重要。然而,五分之一的澳大利亚成年人的卫生知识水平较低,这引起了人们对有效了解卫生信息的关注。本研究旨在评估新南威尔士州(澳大利亚)AOD资源的内容、适用性和可读性,认识到可访问和信息资源在支持AOD需求减少战略中的重要性。方法:在这项研究中,进行了全面的桌面搜索,以分析一到两页的AOD资源,这些资源很容易通过新南威尔士州的互联网访问,由政府和非营利组织发布。对内容进行了深入的分析,因为它涵盖了AOD的关键主题。材料适用性评估(SAM)工具评估视觉和书面元素,检查布局、排版和插图等方面。使用Flesch -Kincaid Grade Level (FKGL)、Gunning Fog Index (Fog)、Simplified Measure of Gobbledygook (SMOG)和Flesch Reading Ease工具评估可读性。计算描述性统计,包括频率、百分比和标准差。结果:本研究分析了88个AOD资源。大多数资源都有目标受众,但只有三种资源在开发过程中涉及到消费者。内容分析显示,66%关注与毒品有关的话题,20%关注与酒精有关的话题,14%两者都涵盖。在酒精资源中很好地处理了怀孕和哺乳期间饮酒等问题。此外,90%的资源有标题和副标题。然而,只有28%的人在布局上得分“优秀”,没有人在排版上得分“优秀”。此外,74%的人没有使用插图来突出关键信息。大多数资源使用主动语态和会话风格,但复杂句子很常见。阅读难度平均为9±2.6,其中FOG和Flesch’s阅读难度为10级,FKGL和SMOG阅读难度为7级。结论:证据强烈表明,在不牺牲内容覆盖率的情况下,需要开发面向低文化水平个体的AOD资源。一个关键的建议是让消费者参与开发和审查这些资源。
{"title":"A comprehensive analysis of alcohol and other drug educational resources available in New South Wales, Australia for content, suitability and readability.","authors":"Aleena Varghese, Rebecca Amanda, Julie Ayre, Kaniz Fatema, Andrew Miles, Gilbert Whitton, Mythily Subramaniam, Amit Arora","doi":"10.1186/s13722-025-00615-5","DOIUrl":"10.1186/s13722-025-00615-5","url":null,"abstract":"<p><strong>Background: </strong>The utilisation of online evidence-based written educational resources is crucial in addressing problematic alcohol and other drugs (AOD) use through prevention, treatment, and intervention strategies. However, low health literacy among one in five Australian adults raises concerns regarding the effective understanding of health information. This study aims to evaluate the content, suitability, and readability of AOD resources in New South Wales (Australia), recognising the importance of accessible and informative resources in supporting AOD demand reduction strategies.</p><p><strong>Methods: </strong>In this research, a comprehensive desktop search was conducted to analyse one to two-page AOD resources readily accessible through the internet in New South Wales, published by government and not-for-profit organisations. The content was thoroughly analysed for its coverage of key AOD topics. The Suitability Assessment of Materials (SAM) instrument evaluated visual and written elements, examining aspects like layout, typography, and illustrations. Readability was assessed using Flesch -Kincaid Grade Level (FKGL), Gunning Fog Index (FOG), Simplified Measure of Gobbledygook (SMOG), and Flesch Reading Ease tools. Descriptive statistics, including frequency, percentage, and standard deviation were calculated.</p><p><strong>Results: </strong>The study analysed 88 AOD resources. Most resources had a target audience, but only three resources involved consumers in the development process. The content analysis showed 66% focused on drug-related topics, 20% on alcohol-related topics, and 14% covered both. Topics such as alcohol use during pregnancy and breastfeeding were well addressed in alcohol resources. Additionally, 90% of the resources had headings and subheadings. However, only 28% scored 'superior' for layout, and none achieved 'superior' ratings for typography. Furthermore, 74% did not use illustrations to highlight key messages. Most resources used an active voice and conversational style, but complex sentences were common. The average reading grade level of the resources was 9 ± 2.6 with FOG and Flesch's reading ease indicating 10th-grade difficulty, while FKGL and SMOG suggested a 7th-grade level.</p><p><strong>Conclusions: </strong>The evidence strongly suggests the need for the development of AOD resources that are accessible to individuals with low literacy levels without sacrificing content coverage. A key recommendation is to involve consumers in both developing and reviewing these resources.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"93"},"PeriodicalIF":3.2,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12670872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145661950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-28DOI: 10.1186/s13722-025-00616-4
Marina Gaeta Gazzola, Allison Torsiglieri, Stephanie Blaufarb, Lauren Velez, Patricia Hernandez, Megan A O'Grady, Donna Shelley, David Frank, Charles M Cleland, Kelly M Doran
Background: Permanent supportive housing (PSH) is an evidence-based intervention for people experiencing homelessness which integrates permanent housing with voluntary support services. PSH tenants are at high risk for overdose death, yet little research to date has examined overdose in PSH. We sought to examine overdose risk and existing responses in PSH, which can shed light on opportunities for future overdose prevention efforts.
Methods: We conducted focus groups with PSH tenants, staff, and leaders in New York City and New York's Capital Region. Focus groups were recorded and professionally transcribed. Two investigators independently completed rapid turnaround qualitative analysis, completing templated summaries of each focus group and compiling key content in an analysis matrix, which a third investigator reviewed; discrepancies were resolved by consensus.
Results: From October to December 2022, we held 8 focus group sessions with PSH tenants (3 focus groups, n = 10 total participants), staff (3 focus groups, n = 13), and leaders (2 focus groups, n = 11) grouped by role and region. Participants were diverse in age (26-67 years), gender (18 women, 16 men), race (3 Asian, 12 Black, 11 White, 5 multiracial, 3 other), and ethnicity (5 Latinx, 29 not Latinx). Analysis revealed four main themes: (1) Overdose was a large concern in PSH and created significant trauma for tenants and staff; (2) Environmental factors in PSH contributed to overdose risk; (3) There was heterogeneity in PSH buildings' current overdose prevention efforts and adoption of harm reduction principles; and (4) Multifactorial barriers resulted in limited tenant use of opioid agonist treatment.
Conclusions: Overdose is a major concern for PSH tenants, staff, and leaders. Our findings shed new light on overdose in PSH settings, providing insight into risk factors, existing responses, and barriers and facilitators to future overdose prevention efforts. These findings can inform future overdose prevention interventions within PSH.
Trial registration: ClinicalTrials.gov, NCT05786222, registered 27 March 2023.
{"title":"Understanding overdose risk and response in permanent supportive housing: results of focus groups with tenants, staff, and leaders.","authors":"Marina Gaeta Gazzola, Allison Torsiglieri, Stephanie Blaufarb, Lauren Velez, Patricia Hernandez, Megan A O'Grady, Donna Shelley, David Frank, Charles M Cleland, Kelly M Doran","doi":"10.1186/s13722-025-00616-4","DOIUrl":"10.1186/s13722-025-00616-4","url":null,"abstract":"<p><strong>Background: </strong>Permanent supportive housing (PSH) is an evidence-based intervention for people experiencing homelessness which integrates permanent housing with voluntary support services. PSH tenants are at high risk for overdose death, yet little research to date has examined overdose in PSH. We sought to examine overdose risk and existing responses in PSH, which can shed light on opportunities for future overdose prevention efforts.</p><p><strong>Methods: </strong>We conducted focus groups with PSH tenants, staff, and leaders in New York City and New York's Capital Region. Focus groups were recorded and professionally transcribed. Two investigators independently completed rapid turnaround qualitative analysis, completing templated summaries of each focus group and compiling key content in an analysis matrix, which a third investigator reviewed; discrepancies were resolved by consensus.</p><p><strong>Results: </strong>From October to December 2022, we held 8 focus group sessions with PSH tenants (3 focus groups, n = 10 total participants), staff (3 focus groups, n = 13), and leaders (2 focus groups, n = 11) grouped by role and region. Participants were diverse in age (26-67 years), gender (18 women, 16 men), race (3 Asian, 12 Black, 11 White, 5 multiracial, 3 other), and ethnicity (5 Latinx, 29 not Latinx). Analysis revealed four main themes: (1) Overdose was a large concern in PSH and created significant trauma for tenants and staff; (2) Environmental factors in PSH contributed to overdose risk; (3) There was heterogeneity in PSH buildings' current overdose prevention efforts and adoption of harm reduction principles; and (4) Multifactorial barriers resulted in limited tenant use of opioid agonist treatment.</p><p><strong>Conclusions: </strong>Overdose is a major concern for PSH tenants, staff, and leaders. Our findings shed new light on overdose in PSH settings, providing insight into risk factors, existing responses, and barriers and facilitators to future overdose prevention efforts. These findings can inform future overdose prevention interventions within PSH.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05786222, registered 27 March 2023.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"91"},"PeriodicalIF":3.2,"publicationDate":"2025-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12664209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145642529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-27DOI: 10.1186/s13722-025-00628-0
Paul Welfordsson, Anna-Karin Danielsson, Anette Søgaard Nielsen, Caroline Björck, Bartosz Grzymala-Lubanski, Kristina Hambraeus, Olga Nilsson, Ida Haugen Löfman, Matthias Lidin, Sara Wallhed Finn
{"title":"Factors associated with alcohol screening and brief interventions: a cross-sectional study of cardiology clinicians in Sweden.","authors":"Paul Welfordsson, Anna-Karin Danielsson, Anette Søgaard Nielsen, Caroline Björck, Bartosz Grzymala-Lubanski, Kristina Hambraeus, Olga Nilsson, Ida Haugen Löfman, Matthias Lidin, Sara Wallhed Finn","doi":"10.1186/s13722-025-00628-0","DOIUrl":"10.1186/s13722-025-00628-0","url":null,"abstract":"","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":" ","pages":"92"},"PeriodicalIF":3.2,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12665207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145642525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-06DOI: 10.1186/s13722-025-00620-8
Ryan Alexander, Noah Woford
Objectives: Among individuals with opioid use disorder using fentanyl, standard initial doses (2-4 mg) of buprenorphine may precipitate withdrawal, often preventing successful induction. Rapid low-dose induction is an emerging approach designed to mitigate this risk. This study describes a simplified rapid low-dose buprenorphine induction protocol in facilitating treatment initiation among patients presenting to an outpatient clinic.
Methods: This case series includes chart review data from nine patients with opioid use disorder treated at an outpatient substance use clinic who were initiated on buprenorphine-naloxone maintenance therapy. All had recent fentanyl use confirmed by UDS. Patients were instructed to follow a simplified induction protocol consisting of 1 mg of buprenorphine-naloxone, via 1/8th of an 8 - 2 mg sublingual film, administered at home hourly for 8 h, followed by maintenance dosing of 8 mg twice daily. Patients were advised to wait at least 24 h since last fentanyl use prior to initiating the induction protocol. Successful induction was defined as being on maintenance treatment at a follow-up appointment one week later.
Results: Of the nine patients who began the rapid low-dose induction protocol, seven successfully transitioned to buprenorphine-naloxone maintenance by the 7-day follow-up. Two patients did not return for follow-up.
Conclusion: In this case series, the simplified rapid low-dose buprenorphine induction protocol was well-tolerated and 77.8% of patients using fentanyl were able to successfully initiate buprenorphine-naloxone maintenance. Benefits of this protocol are use of a single, standard dose of buprenorphine-naloxone, rapid induction timeline over only 8 h, and simple patient instructions.
{"title":"Simplified rapid low-dose buprenorphine induction method for individuals using fentanyl: a case series.","authors":"Ryan Alexander, Noah Woford","doi":"10.1186/s13722-025-00620-8","DOIUrl":"10.1186/s13722-025-00620-8","url":null,"abstract":"<p><strong>Objectives: </strong>Among individuals with opioid use disorder using fentanyl, standard initial doses (2-4 mg) of buprenorphine may precipitate withdrawal, often preventing successful induction. Rapid low-dose induction is an emerging approach designed to mitigate this risk. This study describes a simplified rapid low-dose buprenorphine induction protocol in facilitating treatment initiation among patients presenting to an outpatient clinic.</p><p><strong>Methods: </strong>This case series includes chart review data from nine patients with opioid use disorder treated at an outpatient substance use clinic who were initiated on buprenorphine-naloxone maintenance therapy. All had recent fentanyl use confirmed by UDS. Patients were instructed to follow a simplified induction protocol consisting of 1 mg of buprenorphine-naloxone, via 1/8th of an 8 - 2 mg sublingual film, administered at home hourly for 8 h, followed by maintenance dosing of 8 mg twice daily. Patients were advised to wait at least 24 h since last fentanyl use prior to initiating the induction protocol. Successful induction was defined as being on maintenance treatment at a follow-up appointment one week later.</p><p><strong>Results: </strong>Of the nine patients who began the rapid low-dose induction protocol, seven successfully transitioned to buprenorphine-naloxone maintenance by the 7-day follow-up. Two patients did not return for follow-up.</p><p><strong>Conclusion: </strong>In this case series, the simplified rapid low-dose buprenorphine induction protocol was well-tolerated and 77.8% of patients using fentanyl were able to successfully initiate buprenorphine-naloxone maintenance. Benefits of this protocol are use of a single, standard dose of buprenorphine-naloxone, rapid induction timeline over only 8 h, and simple patient instructions.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"90"},"PeriodicalIF":3.2,"publicationDate":"2025-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12590818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145460760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-30DOI: 10.1186/s13722-025-00618-2
Christopher S Freet, Kirsten Shuler, Sarah Kawasaki, Eric Weintraub, Aaron Greenblatt, Mat Kladney, Edward Nunes, Katrina L Foster, Lan Kong, Nazia Raja-Khan, H Harrington Cleveland, Patricia S Grigson, Scott C Bunce, Timothy R Brick, Jennifer E Nyland
Background: Standard medications for opioid use disorder (MOUD) provide effective treatment pathways for recovery compared with no treatment or behavioral therapies alone. That said, people who continue to use non-prescribed opioids despite treatment with MOUD are at greater risk for high attrition and OUD-related harms. Novel, more effective approaches are needed for the treatment of OUD. To that end, glucagon-like peptide-1 receptor agonists (GLP-1RAs) provide a promising option as a non-opioid pharmacological intervention for OUD. Observational studies suggest that GLP-1RAs decrease craving measures in a residential OUD population but no controlled clinical trials have been conducted to determine if GLP-1RAs increase opioid abstinence and reduce craving in individuals with OUD in an outpatient population. The purpose of the current protocol is to evaluate the potential for the GLP-1RA, semaglutide, to increase abstinence and reduce craving in an outpatient population enrolled in a MOUD program and continue to use non-prescribed opioids.
Method: This protocol is a randomized, double-blind, placebo-controlled clinical trial designed to test the efficacy of the GLP-1RA, semaglutide, in 200 participants enrolled in an outpatient MOUD program (n = 100 buprenorphine; n = 100 methadone) for the treatment of OUD. Outcomes include the probability of participants being abstinent from illicit and nonprescribed opioids, as well as measures of craving and days of drug use. Measures will be evaluated using urine toxicology screens and self-report assessments across 19 weeks during a screening visit (Study Week 1), 12 treatment visits (Study Weeks 2-13), a washout visit (Study Week 14), and a final follow-up visit (Study Week 19).
Discussion: This manuscript describes a phase II clinical protocol to collect data on the efficacy of a GLP-1RA, semaglutide, in persons enrolled in an MOUD program and with ongoing non-prescribed opioid use despite treatment with methadone or buprenorphine. Completion of the current project will support the feasibility of phase III clinical trials for further evaluation in larger outpatient OUD populations that may lead to a new indication for GLP-1RA as a novel and effective treatment for OUD.
Trial registration: ClinicalTrials.gov: NCT06548490. Registered 12 August 2024, https://clinicaltrials.gov/study/NCT06548490 .
{"title":"Efficacy of the GLP-1 receptor agonist, semaglutide, in abstinence from illicit and nonprescribed opioids in an outpatient population with OUD: a randomized, double-blind, placebo-controlled clinical trial protocol.","authors":"Christopher S Freet, Kirsten Shuler, Sarah Kawasaki, Eric Weintraub, Aaron Greenblatt, Mat Kladney, Edward Nunes, Katrina L Foster, Lan Kong, Nazia Raja-Khan, H Harrington Cleveland, Patricia S Grigson, Scott C Bunce, Timothy R Brick, Jennifer E Nyland","doi":"10.1186/s13722-025-00618-2","DOIUrl":"10.1186/s13722-025-00618-2","url":null,"abstract":"<p><strong>Background: </strong>Standard medications for opioid use disorder (MOUD) provide effective treatment pathways for recovery compared with no treatment or behavioral therapies alone. That said, people who continue to use non-prescribed opioids despite treatment with MOUD are at greater risk for high attrition and OUD-related harms. Novel, more effective approaches are needed for the treatment of OUD. To that end, glucagon-like peptide-1 receptor agonists (GLP-1RAs) provide a promising option as a non-opioid pharmacological intervention for OUD. Observational studies suggest that GLP-1RAs decrease craving measures in a residential OUD population but no controlled clinical trials have been conducted to determine if GLP-1RAs increase opioid abstinence and reduce craving in individuals with OUD in an outpatient population. The purpose of the current protocol is to evaluate the potential for the GLP-1RA, semaglutide, to increase abstinence and reduce craving in an outpatient population enrolled in a MOUD program and continue to use non-prescribed opioids.</p><p><strong>Method: </strong>This protocol is a randomized, double-blind, placebo-controlled clinical trial designed to test the efficacy of the GLP-1RA, semaglutide, in 200 participants enrolled in an outpatient MOUD program (n = 100 buprenorphine; n = 100 methadone) for the treatment of OUD. Outcomes include the probability of participants being abstinent from illicit and nonprescribed opioids, as well as measures of craving and days of drug use. Measures will be evaluated using urine toxicology screens and self-report assessments across 19 weeks during a screening visit (Study Week 1), 12 treatment visits (Study Weeks 2-13), a washout visit (Study Week 14), and a final follow-up visit (Study Week 19).</p><p><strong>Discussion: </strong>This manuscript describes a phase II clinical protocol to collect data on the efficacy of a GLP-1RA, semaglutide, in persons enrolled in an MOUD program and with ongoing non-prescribed opioid use despite treatment with methadone or buprenorphine. Completion of the current project will support the feasibility of phase III clinical trials for further evaluation in larger outpatient OUD populations that may lead to a new indication for GLP-1RA as a novel and effective treatment for OUD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT06548490. Registered 12 August 2024, https://clinicaltrials.gov/study/NCT06548490 .</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"89"},"PeriodicalIF":3.2,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12573902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145410543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-27DOI: 10.1186/s13722-025-00611-9
Rebecca E Rottapel, Thomas J Stopka, Peter D Friedmann, Randall A Hoskinson, Daviana Englander, Nicole Calhoun, Thomas Senst, Christopher Gudas, Peter J Koutoujian, David Farabee
Context/background: The high prevalence of opioid use among jailed adults offers an unmatched opportunity to identify and treat those with opioid use disorder (OUD), a population that is at a substantial risk for post-release overdose. From a public health perspective, jails are critical touchpoints, as these facilities typically admit more than 7 million adults per year. One clinical consideration is whether pre-trial detainees with OUD would benefit from early induction onto extended-release buprenorphine (XRB).
Methods/study design: In this 3-year randomized controlled trial, we will identify and recruit 200 incarcerated adults with OUD who are receiving sublingual buprenorphine (SLB) or tolerate a SLB test dose and randomize them to receive extended release buprenorphine (XRB) (n = 100) or to remain on SLB (n = 100) while in custody. Study participation will continue through their pre-trial time in jail (up to 6 months) or until they are sentenced or released. Community treatment will then be tracked for 90 days following release. In addition to collecting data on XRB uptake in jail, we will assess (1) the percentage of XRB and SLB study participants leaving jail with a clinically active dose of buprenorphine in their system, (2) 90- day post-release MOUD continuation, (3) levels of buprenorphine diversion while in custody, and (4) recidivism and death (90 days). "Clinically active" is defined as receiving XRB within the past 28 days or SLB in the past 24 h.
Discussion: Findings from this study will demonstrate the feasibility and outcomes of inducting pre-trial adults with OUD onto XRB, as well as offer practical clinical and policy guidelines for best practices for treating this high risk and understudied population.
{"title":"A protocol for a randomized comparison of extended-release versus sublingual buprenorphine among pre-trial detainees in jail.","authors":"Rebecca E Rottapel, Thomas J Stopka, Peter D Friedmann, Randall A Hoskinson, Daviana Englander, Nicole Calhoun, Thomas Senst, Christopher Gudas, Peter J Koutoujian, David Farabee","doi":"10.1186/s13722-025-00611-9","DOIUrl":"10.1186/s13722-025-00611-9","url":null,"abstract":"<p><strong>Context/background: </strong>The high prevalence of opioid use among jailed adults offers an unmatched opportunity to identify and treat those with opioid use disorder (OUD), a population that is at a substantial risk for post-release overdose. From a public health perspective, jails are critical touchpoints, as these facilities typically admit more than 7 million adults per year. One clinical consideration is whether pre-trial detainees with OUD would benefit from early induction onto extended-release buprenorphine (XRB).</p><p><strong>Methods/study design: </strong>In this 3-year randomized controlled trial, we will identify and recruit 200 incarcerated adults with OUD who are receiving sublingual buprenorphine (SLB) or tolerate a SLB test dose and randomize them to receive extended release buprenorphine (XRB) (n = 100) or to remain on SLB (n = 100) while in custody. Study participation will continue through their pre-trial time in jail (up to 6 months) or until they are sentenced or released. Community treatment will then be tracked for 90 days following release. In addition to collecting data on XRB uptake in jail, we will assess (1) the percentage of XRB and SLB study participants leaving jail with a clinically active dose of buprenorphine in their system, (2) 90- day post-release MOUD continuation, (3) levels of buprenorphine diversion while in custody, and (4) recidivism and death (90 days). \"Clinically active\" is defined as receiving XRB within the past 28 days or SLB in the past 24 h.</p><p><strong>Discussion: </strong>Findings from this study will demonstrate the feasibility and outcomes of inducting pre-trial adults with OUD onto XRB, as well as offer practical clinical and policy guidelines for best practices for treating this high risk and understudied population.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"88"},"PeriodicalIF":3.2,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12560400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145379850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-27DOI: 10.1186/s13722-025-00613-7
Peter Næsborg Schøler, Per Nilsen, Sanne Rasmussen, Jens Søndergaard, Anette Søgaard Nielsen
{"title":"Adaptations and modifications to the 15-method in Danish general practice classified using the framework for reporting adaptations and modifications to evidence-based interventions (FRAME).","authors":"Peter Næsborg Schøler, Per Nilsen, Sanne Rasmussen, Jens Søndergaard, Anette Søgaard Nielsen","doi":"10.1186/s13722-025-00613-7","DOIUrl":"10.1186/s13722-025-00613-7","url":null,"abstract":"","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"87"},"PeriodicalIF":3.2,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12557837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145379798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-24DOI: 10.1186/s13722-025-00617-3
Angela R Bazzi, Hansel E Tookes, Tyler S Bartholomew
{"title":"Advancing pre-exposure prophylaxis (PrEP) implementation for people who use drugs: an introduction to and lessons from the special series.","authors":"Angela R Bazzi, Hansel E Tookes, Tyler S Bartholomew","doi":"10.1186/s13722-025-00617-3","DOIUrl":"10.1186/s13722-025-00617-3","url":null,"abstract":"","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"86"},"PeriodicalIF":3.2,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12553240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145369291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}