SMART Effectiveness Trial

Not Applicable

Completed

Conditions: Opioid Dependence
Opioid-use Disorder
Treatment Adherence

Interventions: Behavioral: Contingency Management (CM)
Behavioral: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)

Registration Number: NCT04464421

Lead Sponsor: Karen Derefinko, PhD

Brief Summary: The current study piloted two psychosocial interventions developed to increase buprenorphine-naloxone adherence in individuals with opioid use disorder (OUD). Participants were randomized to receive either contingency management (CM) or a brief substance free activities session plus mindfulness (BSM) cognitive-behavioral intervention. Participants were 48 newly presenting patients from an OUD treatment clinic. The primary outcome was medication adherence, as measured by buprenorphine metabolite in urine and presence at 2 or more of 4 possible physician visits.

Detailed Description: We engaged with referred OUD patients at the time of their initial visit to the clinic. Interested patients were informed about the study in a private room, and if eligible, were consented and randomized to condition. Randomization occurred in blocks of 4. At the next physician visit, participants engaged in their first intervention activities (either CM or BSM). This was repeated for the following 3 physician visits.

CM. Contingency Management (CM). The CM intervention provided participants with a gift card at each of the first 4 follow up physician visits to the clinic where the participant's urine showed evidence of buprenorphine use. The strategy for CM rewards was based upon Petry's "fishbowl" draw, where variable values of gift cards were available for draw at each positive buprenorphine urine toxicology result. For the current study, which was conducted when COVID safety requirements were still high, a computerized "picker wheel" was used rather than an actual fishbowl to reduce possible viral transmission. Participants watched the wheel spin and told the interventionist when to stop the spin, at which time the value of the gift card was displayed. The picker wheel was programmed to include a 60% chance of a $25 gift card, a 20% chance of a $50 gift card, and a 20% chance of a $100 gift card. The average (expected) value of gift cards at this rate was $45 (or $180 total across 16 weeks, well below the typical range used in similar work).

BSM. Brief Motivational Interviewing plus Substance Free Activities Session plus Mindfulness (BSM). The BSM intervention included the following topics: (1) Short and Long-Term Goals: Identifying goals (e.g., What are your goals for this month...for the next 5 years?), requirements needed to achieve these goals (e.g., What would you need to do to achieve those goals?) and the potential role of relapse in jeopardizing these goals; (2) Personalized Feedback on Recent Time Allocation: (e.g., time spent with family, work, education/hobbies/creative activities, exercise/time in nature/self-care, watching tv/surfing the internet, religious or spiritual activities, recovery and nonrecovery activities; along with open ended questions asking about the extent to which their recent time allocation is consistent with their goals and values; (3) Episodic Future Thinking: An experiential intervention that prompts individuals to describe personal, emotional, and situational details of a valued future outcome that they desire; (4) Substance Free Activities: Based upon named hobbies and interests, participants were offered a personalized list of locally available substance-free activities developed by the interventionist; (5) Stop Observe Breathe Expand Respond (SOBER) Breathing Space: This exercise is intended to bring awareness to one's experiences without judgment. This technique includes the following steps: Stop or Slow down. Observe what is happening. Bring attention to Breathing. Expand awareness to the whole body. Respond mindfully, with awareness.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

Present for an intake appointment at study site for treatment of opioid use disorder.
Eligible for receipt of buprenorphine-naloxone treatment (e.g. Suboxone, Bunavil, Zubsolv) as determined by clinic physicians
18 years or older
Willing to be randomized to one of the two intervention arms
Ability to comprehend consent and intervention materials (approximately 8th-grade level).

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency management (CM)	Contingency Management (CM)	Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.
BSM	Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)	BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.

Primary Outcome Measures

Name	Time	Method
Treatment Adherence	Through study completion, an average of 4 months	Defined as no negative buprenorphine urine tests and attendance of at least two visits.

Secondary Outcome Measures