SMART Effectiveness Trial

NCT ID: NCT04464421

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-17
• Study Completion Date: 2021-08-29

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.

Conditions

Opioid-use Disorder; Opioid Dependence; Treatment Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Contingency Management (CM)

Intervention Type: BEHAVIORAL

Participants were able to draw a gift card from a virtual fishbowl when their urine toxicology results are positive for buprenorphine metabolites. Gift card values were $25, $50, or $100.

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.

Group Type: EXPERIMENTAL

Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)

Intervention Type: BEHAVIORAL

Participants had one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, the importance of substance-free activities, and mindfulness skills.

Interventions

Contingency Management (CM)

Participants were able to draw a gift card from a virtual fishbowl when their urine toxicology results are positive for buprenorphine metabolites. Gift card values were $25, $50, or $100.

Intervention Type: BEHAVIORAL

Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)

Participants had one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, the importance of substance-free activities, and mindfulness skills.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Memphis

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: collaborator

Karen Derefinko, PhD

OTHER

Sponsor Role: lead

Responsible Party

Karen Derefinko, PhD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karen J Derefinko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-07418-XP UM

Identifier Type: -

Identifier Source: org_study_id