Journal of substance use and addiction treatment最新文献

Introduction: Cigarette smoking rates among pregnant women with opioid use disorder (OUD), are significantly higher than those found in the general population.

Methods: We conducted a secondary analysis of baseline data from a multisite, randomized clinical trial comparing two different buprenorphine formulations on outcomes during pregnancy. Cigarette use and smoking cessation goals were evaluated with the Fagerström Test for Nicotine Dependence and the Thoughts About Abstinence (TAA) questionnaire respectively. Factors associated with differences in cigarette use and smoking cessation goals were compared.

Results: Among 156 participants, 85 (54.5 %) reported that they currently smoked cigarettes. Most participants had a desire to quit smoking (TAA score = 6), but they had low expectations of success (TAA score = 4) and a relatively high perceived difficulty (TAA score = 6.5) of quitting during pregnancy. Among participants who smoked, less than half (45.5 %) had a smoking cessation goal. Participants who had a smoking cessation goal were significantly more likely to have a stronger desire to quit and higher expectations of success in quitting than participants who did not have a goal.

Conclusions: Many pregnant women with OUD would like to quit or reduce smoking during pregnancy. A combination of pharmacologic and non-pharmacologic interventions to reduce or eliminate cigarette use should be incorporated into obstetric and substance use treatment clinical settings. Smoking cessation interventions should be aligned with patients' goals and preferences.

Trial registration: Clinical Trials.govhttp://www.

Clinicaltrials: gov; Identifier: NCT03918850.

This commentary examines methodological and ethical problems encountered when a multi-arm clinical trial loses access to one or more of its arms, using the Retention Phase of the NIDA Clinical Trials Network CTN-0100 study, Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) as an example. RDD is a community-based, multi-site trial testing strategies to reduce dropout from medication treatment for opioid use disorder. Among patients with opioid use disorder initiating buprenorphine treatment, the original design was a 3 by 2 factorial comprising 3 pharmacological conditions (Standard-Dose sublingual buprenorphine-16 mg/day target [SL-BUP 16], High-Dose sublingual buprenorphine-32 mg/day target [SL-BUP 32], or extended-release injectable buprenorphine [XR-BUP]), crossed with 2 behavioral conditions: medical management with vs. without a technology-based digital therapeutic app providing cognitive behavioral therapy lessons and contingency management. The trial experienced two major disruptions to study interventions: 1) The supply of XR-BUP became temporarily unavailable due to manufacturing problems; and 2) The company supplying the digital therapeutic app went bankrupt, rendering the original app permanently unavailable. Questions considered by the study lead team included: 1) Whether to pause recruitment into the trial altogether or continue recruitment into truncated designs omitting the unavailable interventions; 2) How to account for participants who did not experience full exposure to the halted interventions; 3) Whether to substitute a similar intervention; and 4) The problem of concurrent randomizations, namely that a truncated design does not contain all the concurrent randomizations of the full design, introducing risk of confounding or bias. This experience from the RDD trial demonstrates how multi-arm clinical trials that lose access to an intervention arm can continue with a truncated design, allowing continued progress on study aims, while balancing methodological purity with the pragmatic imperative to keep the trial running and respect subjects' participation.