Opioid-use DisorderNCT04464421
SMART Effectiveness Trial
A study testing Contingency Management (CM) and Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) in people with Opioid-use Disorder and Opioid Dependence, run by Karen Derefinko, PhD at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Opioid Dependence, Treatment Adherence
- What is being tested?
- Contingency Management (CM) and Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 29 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion
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.
Read the 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
- Being tested
- Contingency Management (CM), Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)
- Keywords
- opioid use disorder, OUD, buprenorphine, treatment adherence, substance-free activities, brief motivational interviewing, contingency management
- Medical subject headings
- Opioid-Related Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management (CM)Behavioural
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.
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingency management (CM) | Experimental | 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. Receives: Behavioral: Contingency Management (CM) |
| BSM | Experimental | 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. Receives: Behavioral: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Defined as no negative buprenorphine urine tests and attendance of at least two visits.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start17 Aug 2020
- Primary completion30 Jul 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Derefinko, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis, University of New Mexico
- Responsible party
- Sponsor-investigator, Karen Derefinko, PhD, University of Tennessee
- Investigators
- Karen J Derefinko, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464421
- Sponsor's protocol ID
- 20-07418-XP UM
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2020
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion
- ClinicalTrials.gov ID
- NCT04464421
- Acronym / sponsor ID
- 20-07418-XP UM
- Conditions
- Opioid-use Disorder, Opioid Dependence, Treatment Adherence
- Keywords
- opioid use disorder, OUD, buprenorphine, treatment adherence, substance-free activities, brief motivational interviewing, contingency management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Karen Derefinko, PhDUniversity, hospital or other
- Collaborators
- University of Memphis, University of New Mexico
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Posted 10 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency management (CM) | Experimental | Behavioral: 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 | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Contingency management (CM) |
| 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. | Behavioural | BSM |
Primary outcome
Treatment Adherence
Time frame: Through study completion, an average of 4 months
Defined as no negative buprenorphine urine tests and attendance of at least two visits.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid-use Disorder
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Active, not recruiting
Facilitating Opioid Care Connections
Opioid Court Model, Medication to Treat Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J Derefinko, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management (CM) and Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) in people with Opioid-use Disorder and Opioid Dependence, run by Karen Derefinko, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.