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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | Experimental | Participants will receive financial incentives for buprenorphine use and opiate abstinence. |
|
| Buprenorphine Adherence Only | Experimental | Participants will receive financial incentives for buprenorphine use. |
|
| Control | No Intervention | Participants will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management for adherence | Behavioral | Incentives contingent on buprenorphine adherence |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Silverman, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Learning and Health | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine Adherence and Opiate Abstinence | Participants will receive financial incentives for buprenorphine use and opiate abstinence. Contingency Management for adherence: Incentives contingent on buprenorphine adherence Contingency Management for abstinence: Incentives contingent on opiate abstinence |
| FG001 | Buprenorphine Adherence Only | Participants will receive financial incentives for buprenorphine use. Contingency Management for adherence: Incentives contingent on buprenorphine adherence |
| FG002 | Control | Participants will not receive any intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine Adherence and Opiate Abstinence | Participants will receive financial incentives for buprenorphine use and opiate abstinence. Contingency Management for adherence: Incentives contingent on buprenorphine adherence Contingency Management for abstinence: Incentives contingent on opiate abstinence |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of urine samples | 12 weeks | urine samples | urine samples |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine Adherence and Opiate Abstinence | Participants will receive financial incentives for buprenorphine use and opiate abstinence. Contingency Management for adherence: Incentives contingent on buprenorphine adherence Contingency Management for abstinence: Incentives contingent on opiate abstinence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Silverman, Ph.D. | Johns Hopkins University School of Medicine | 4436176051 | ksilverm@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2023 | Dec 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Contingency Management for abstinence | Behavioral | Incentives contingent on opiate abstinence |
|
| Buprenorphine Adherence Only |
Participants will receive financial incentives for buprenorphine use. Contingency Management for adherence: Incentives contingent on buprenorphine adherence |
| BG002 | Control | Participants will not receive any intervention. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Control | Participants will not receive any intervention. |
|
|
|
| Primary | 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. | Posted | Number | percentage of urine samples | 12 weeks | urine samples | urine samples |
|
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | 12 weeks |
|
|
|
|
| 1 |
| 123 |
| 5 |
| 123 |
| 0 |
| 123 |
| EG001 | Buprenorphine Adherence Only | Participants will receive financial incentives for buprenorphine use. Contingency Management for adherence: Incentives contingent on buprenorphine adherence | 0 | 128 | 4 | 128 | 0 | 128 |
| EG002 | Control | Participants will not receive any intervention. | 0 | 124 | 2 | 124 | 0 | 124 |
| Assault | General disorders | Systematic Assessment |
|
| Covid | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| endocarditis with heart surgery for pace maker | Surgical and medical procedures | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
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| Psychiatric | Psychiatric disorders | Systematic Assessment |
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| Pulmonary embolism | Blood and lymphatic system disorders | Systematic Assessment |
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| blood clot in lungs | Blood and lymphatic system disorders | Systematic Assessment |
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| seizure | Nervous system disorders | Systematic Assessment |
|
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| Odds Ratio (OR) |
| 1.38 |
| 2-Sided |
| 95 |
| 0.571 |
| 3.336 |
| Superiority |
| Odds Ratio (OR) |
| 0.724 |
| 2-Sided |
| 95 |
| 0.322 |
| 1.627 |
| Superiority |