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Contingency Management to Enhance Office-Based Buprenorphine Treatment
NA trial testing Contingency Management for adherence in Opioid-use Disorder in 375 participants. Completed in 1 July 2024.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 375 |
| Start date | 31 January 2020 |
| Primary completion | 30 June 2023 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across United States |
Johns Hopkins University
Adults 18 to 100, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
| Group | Value | 95% CI |
|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | 80 | |
| Buprenorphine Adherence Only | 84 | |
| Control | 78 |
This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.
| Group | Value | 95% CI |
|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | 83 | |
| Buprenorphine Adherence Only | 85 | |
| Control | 80 |
This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.
| Group | Value | 95% CI |
|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | 16.12 | |
| Buprenorphine Adherence Only | 16.28 | |
| Control | 18.82 |
Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Buprenorphine Adherence an… | Buprenorphine Adherence Only | Control |
|---|---|---|---|---|
| Infection | Infections and infestations | — | — | — |
| Breast Cancer | General disorders | — | — | — |
| Assault | General disorders | — | — | — |
| Covid | Respiratory, thoracic and mediastinal disorders | — | — | — |
| endocarditis with heart surgery for pace maker | Surgical and medical procedures | — | — | — |
| Psychiatric | Psychiatric disorders | — | — | — |
| Pulmonary embolism | Blood and lymphatic system disorders | — | — | — |
| blood clot in lungs | Blood and lymphatic system disorders | — | — | — |
| seizure | Nervous system disorders | — | — | — |
Most-reported serious reactions: Infection, Breast Cancer, Assault, Covid, endocarditis with heart surgery for pace maker, Psychiatric, Pulmonary embolism, blood clot in lungs.
Data from ClinicalTrials.gov NCT04024059 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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