Recruitment, screening, randomization, and procedure
CM
We will engage with referred MOUD patients at the time of their initial visit to the university-based addictions clinic. Interested patients will be informed about the study in a private room and, if eligible, will be consented and randomized to condition.Randomization for Stage 1 and Stage 2 is a 2-arm, parallel, random assignment with 1:1 allocation ratio using block-randomization (blocks of 4) developed by the study statistician with separate blocks for males and females to avoid coincidental assignment imbalance over time and to ensure that males and females are comparatively represented in both of the respective randomization points. Randomization sequence will be stored in a database where the sequence is concealed until participants are enrolled and interventions are assigned by the study coordinators. Buprenorphine providers and the outcomes assessor will be blinded to condition.Following randomization, participants will start their assigned intervention at their physician visits for MOUD. Notably, patients’ MOUD visit schedules vary during treatment initiation and, depending upon circumstances, can occur weekly, bi-weekly, or monthly.At each of these 4 MOUD physician visits (known as treatment initiation regardless of time period between visits), participants will complete assessments, then engage in intervention activities. Those who are adherent to buprenorphine-naloxone (i.e., attend physician visits and demonstrate presence of buprenorphine in urine screen) during this 4-visit period will remain in their intervention condition for up to 6 months (maintenance intervention). A final assessment will be conducted at 8 months from Stage 1 randomization.Those who are not adherent to buprenorphine-naloxone, defined as missing their physician visit or absence of buprenorphine in urine screen, will be re-randomized to either switch to the other intervention condition or add the other intervention (CM + BSM combined). We expect that about 50% of the participants will be initially non-adherent and will qualify to be re-randomized. For re-randomized participants, intervention will start from the beginning.