An interventional study of Contingency Management for adherence and Contingency Management for abstinence in Opioid-use Disorder, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period.
Opioid use has increased to epidemic levels in the United States and has been associated with a dramatic increase in overdose deaths. Buprenorphine is a safe, well-tolerated, and evidence-based medication for opioid use disorder that can be prescribed in office-based treatment settings. Office-based buprenorphine could be an effective way to expand treatment for opioid use disorder, and thereby combat the opioid epidemic. However, office-based buprenorphine has three limitations that must be addressed to facilitate the safe and effective expansion of buprenorphine treatment: 1) Many patients discontinue buprenorphine treatment prematurely, 2) some patients divert buprenorphine for illicit use, and 3) many patients continue to use illicit opioids during buprenorphine treatment. This project will address these limitations by using a psychosocial approach known as Contingency Management. Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period. If the proposed intervention is effective, it could encourage medical professionals to prescribe buprenorphine, and improve patients' access to and success in office-based buprenorphine treatment.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 375 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive financial incentives for buprenorphine use and opiate abstinence.
Behavioral: Contingency Management for adherence · Behavioral: Contingency Management for abstinence
Participants will receive financial incentives for buprenorphine use.
Behavioral: Contingency Management for adherence
Participants will not receive any intervention.
Incentives contingent on buprenorphine adherence
Incentives contingent on opiate abstinence
Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples
This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
Time frame: 12 weeks
Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples
This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.
Time frame: 12 weeks
Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine
This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.
Time frame: 12 weeks
| Milestone | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control |
|---|---|---|---|
| Started | 123 | 128 | 124 |
| Completed | 112 | 126 | 119 |
| Not completed | 11 | 2 | 5 |
This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
| percentage of urine samples | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control |
|---|---|---|---|
| Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples | 80 | 84 | 78 |
This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.
| percentage of urine samples | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control |
|---|---|---|---|
| Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples | 83 | 85 | 80 |
This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.
| percentage of participants | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control |
|---|---|---|---|
| Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine | 16.12 | 16.28 | 18.82 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | 1/123 (0.8%) | 5/123 (4.1%) | 0/123 (0%) |
| Buprenorphine Adherence Only | 0/128 (0%) | 4/128 (3.1%) | 0/128 (0%) |
| Control | 0/124 (0%) | 2/124 (1.6%) | 0/124 (0%) |
| Event | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control |
|---|---|---|---|
| InfectionInfections and infestations | 2/123 | 0/128 | 0/124 |
| endocarditis with heart surgery for pace makerSurgical and medical procedures | 1/123 | 0/128 | 0/124 |
| PsychiatricPsychiatric disorders | 1/123 | 0/128 | 1/124 |
| blood clot in lungsBlood and lymphatic system disorders | 1/123 | 0/128 | 0/124 |
| Pulmonary embolismBlood and lymphatic system disorders | 0/123 | 0/128 | 1/124 |
| Breast CancerGeneral disorders | 0/123 | 1/128 | 0/124 |
| AssaultGeneral disorders | 0/123 | 1/128 | 0/124 |
| CovidRespiratory, thoracic and mediastinal disorders | 0/123 | 1/128 | 0/124 |
| seizureNervous system disorders | 0/123 | 1/128 | 0/124 |
| Age, Categorical(Participants) | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 119 | 127 | 124 | 370 |
| >=65 years | 4 | 1 | 0 | 5 |
| Age, Continuous(years) | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| Mean | 42 ± 11 | 42 ± 10 | 41 ± 10 | 42 ± 10 |
| Sex: Female, Male(Participants) | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| Female | 41 | 62 | 48 | 151 |
| Male | 82 | 66 | 76 | 224 |
| Ethnicity (NIH/OMB)(Participants) | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 4 | 7 |
| Not Hispanic or Latino | 122 | 126 | 120 | 368 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 3 | 7 |
| Asian | 3 | 0 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 36 | 24 | 33 | 93 |
| White | 82 | 97 | 84 | 263 |
| More than one race | 0 | 3 | 2 | 5 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 |
| Region of Enrollment(Participants) | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| United States | 123 | 128 | 124 | 375 |
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