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1. Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder

Author

Samuel C. Peter, James G. Murphy, Katie Witkiewitz, Sarah B. Hand, Fridtjof Thomas, Karen Chandler Johnson, Ronald Cowan, Matt Harris, and Karen J. Derefinko

Subjects
Behavioral economics, Contingency management, Substance-free activities, Brief motivational intervention, Opioid use disorder, Sequential Multiple Assignment Randomized Trial, Medicine (General), R5-920
Abstract

Abstract Background Buprenorphine-naloxone is a medication shown to improve outcomes for individuals seeking treatment for opioid use disorder (OUD); however, outcomes are limited by low medication adherence rates. This is especially true during the early stages of treatment. Methods The present study proposes to utilize a sequential multiple assignment randomized trial design to compare two psychological interventions targeting buprenorphine-naloxone adherence: (1) contingency management (CM) and (2) brief motivational interviewing plus substance-free activities session plus mindfulness (BSM). Participants will be N = 280 adults who present to a university-based addictions clinic seeking treatment for OUD. Participants will be randomized to condition to receive 4 sessions of their assigned intervention (CM or BSM). Participants who are adherent, defined as attending physician appointments and having buprenorphine present in urine toxicology, will enter maintenance intervention for an additional 6 months. Those who are not adherent will be re-randomized to receive either the other intervention or both interventions. Follow-up will occur at 8 months post-randomization. Conclusions This novel design will examine the benefit of sequential treatment decisions following non-adherence. The primary outcome of this study is buprenorphine-naloxone medication adherence, as assessed by physician visit attendance and presence of buprenorphine in urine. Results will elicit the relative efficacy of CM and BSM compared to one another and whether keeping the initial treatment approach when adding the alternative approach for initially non-adherent individuals is beneficial. Trial registration ClinicalTrials.gov NCT04080180

Published
2023
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2. Planning a Change Easily (PACE) for smokers who are not ready to quit: a telephone-based, randomized controlled trial

Author

Karen J. Derefinko, Zoran Bursac, Sarah B. Hand, Jon O. Ebbert, Catherine Womack, and Robert C. Klesges

Subjects
Adult, Male, Psychiatry and Mental health, Nicotine, Smokers, Medicine (miscellaneous), Humans, Female, Smoking Cessation, Motivational Interviewing, Middle Aged, Article, Telephone
Abstract

AIMS: To compare brief advice (BA), motivational interviewing (MI), rate reduction (RR), and combined MI and RR (MI + RR) to promote smoking cessation in smokers not ready to quit. DESIGN: Randomized controlled trial with four parallel groups of smoking cessation intervention. Participants were randomly assigned 1:2:2:2 to receive one of the following interventions: BA (n = 128), MI (n = 258), RR (n = 257), and MI + RR (n = 260). SETTING: The United States. All participant contact occurred over the telephone to be consistent with the typical quit line format. PARTICIPANTS: A total of 903 adult smokers. Participants had a mean age of 49 (SD = 13.3) years and were 28.9% male and 63.3% Caucasian. INTERVENTIONS: The BA group received advice similar to typical smoking cessation quit lines. The MI group received advice using basic MI principles to elicit language that indicates behavioral change. The RR group received behavioral skills training and nicotine gum. The MI + RR group combined elements of MI and RR conditions. All interventions were six sessions. MEASUREMENTS: The primary outcome measure was self-reported point prevalence at 12 months. The secondary outcome was self-reported prolonged abstinence at 12 months. FINDINGS: Intention to treat (ITT) point prevalence at 12 months indicated that BA (10.9%) had significantly lower point prevalence rates than RR (27.2%, OR = 3.17, 1.69–5.94), and MI + RR (26.9%, OR = 3.16, 1.68–5.93). BA did not have a significantly lower point prevalence rate than MI (15.5%, OR = 1.56, 95% CI = 0.81–3.02). CONCLUSIONS: This randomized controlled trial provided evidence that rate reduction, which offers structured behavioral skills and nicotine gum, either alone or combined with motivational interviewing, is the most effective form of cessation intervention for smokers not ready to quit.

Published
2021

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