Time-Lagged Association between Counseling And/Or 12-Step Attendance with Subsequent Opioid Use in a Randomized, Clinical Trial of Medications for Opioid Use Disorder

Abstract

Introduction: Psychosocial support is recommended in conjunction with medication for opioid use disorder (MOUD), although optimal 'dose,' modality, and timing of participation is not established. This study comprised a secondary analysis of counseling and 12-Step (AA/NA) attendance and its relationship with subsequent opioid use in a MOUD randomized clinical trial.

Methods: The parent study randomly assigned 570 participants to receive buprenorphine-naloxone (BUP-NX, n=287) or extended-release injectable naltrexone (XR-NTX, n=283). Mixed-effects logistic regression models were fit with Opioid Use (urine screen; Timeline Followback) as the response variable, and a counseling/12-Step attendance predictor. Differences by treatment assignment were examined.

Results: Any attendance of counseling or 12-Step reported at the index visit was associated with reduced odds of opioid use at the subsequent visit, whether considered individually or aggregated across type. A continuous relationship was observed for 12-Step attendance (F(1,5083)=5.01, p=.025); with each additional hour associated with additional 13% (95% CI: 0.83, 0.90) reduction in odds of opioid use at the subsequent visit. The associations between hours of 12-Step and group counseling attendance and opioid use also grew over time throughout the trial. Any attendance in group (F(1,5083)=6.06, p=.014) and 12-Step (F(1,5083)=5.11, p=.024) counseling displayed differential effects by treatment arm. In the BUP-NX group, group counseling was associated with a greater reduction in odds of opioid use than for XR-NTX, (OR=0.32 (95% CI: .22, 0.48) vs. OR=0.69 (95% CI: 0.43, 1.08)). In contrast, in the XR-NTX group, 12-Step was associated with a greater reduction in odds of opioid use (OR=0.35 (95% CI: 0.22, 0.54) vs. OR=0.65 (95% CI: 0.47, 0.89) for BUP-NX)).

Conclusions: Counseling and 12-Step attendance has a proximal association with opioid use outcomes, and the strength of that association may grow with dose and time. Attendance of any type of psychosocial counseling and/or 12-step may promote reduced opioid use. Alternatively, more motivated individuals may both attend more counseling/12-Step and have better treatment outcomes, or the relationship may be reciprocal.

Note:
Trial Registration Details: The current study is a secondary data analysis of CTN-0051, a multi-site, open-label, randomized controlled trial sponsored by the National Institute on Drug Abuse through its National Drug Abuse Treatment Clinical Trials Network (NDAT CTN).

Funding Information: This study was supported by HHSN271201400028C, U10DA013046, UG1/U10DA013035, and C75N95020D00012 / N01DA-20-2251).

Declaration of Interests: Dr. Hefner has no conflict of interest to declare. Dr. Shmueli-Blumberg has no conflict of interest to declare. Dr. Campbell has no conflict of interest to declare. Dr. Pavlicova has no conflict of interest to declare. Dr. Fishman serves as a consultant for Alkermes, a consultant for Drug Delivery LLC, holds a research grant from Alkermes and a research grant from Medicasafe. Ms. Meyers-Ohki has no conflicts of interest to declare. Dr. Shulman has no conflicts of interest to declare. Dr. Greiner has no conflicts of interest to declare. Ms. Novo has no conflicts of interest to declare. Dr. Rotrosen has served as a Principal Investigator or a co-Investigator on studies for which support in the form of donated medication and/or funds has been, or is, provided by Indivior, Alkermes, and Braeburn, and apps provided by Pear Therapeutics, CHESS Health, and Data [Psychosocial support and opioid use in MOUD trial] 3 Cubed. Dr. Rotrosen recently served in a non-paid capacity as a member of an Alkermes study Steering Committee. Dr. Nunes has served as a Principal Investigator or co-Investigator on studies for which support in the form of donated medication and/or funds has been, or is, provided by Indivior, Alkermes, and Braeburn-Camurus, and digital therapeutics provided by Pear Therapeutics and CHESS Health, and has served as an unpaid consultant to Alkermes, Braeburn-Camurus and Pear Therapeutics.

Ethics Approval Statement: The research was conducted ethically and adhered to appropriate human subject protections, and was approved by the NYU Langone School of Medicine IRB and local site IRBs.

Keywords: opioid use disorder, psychosocial counseling, 12-Step, medication for opioid use disorder (MOUD)