Opioid-use Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALContingency Management for adherence
Incentives contingent on buprenorphine adherence
BEHAVIORALContingency Management for abstinence
Incentives contingent on opiate abstinence
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Opioid use disorder * Enrolled in buprenorphine treatment
Exclusion criteria
* Unwilling or unable to use a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples | 12 weeks | This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention. |
| Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples | 12 weeks | This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine | 12 weeks | This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 123 |
| Buprenorphine Adherence Only Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence | 128 |
| Control Participants will not receive any intervention. | 124 |
| Total | 375 |
Baseline characteristics
| Characteristic | Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence Only | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 0 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 127 Participants | 124 Participants | 370 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 11 | 42 years STANDARD_DEVIATION 10 | 41 years STANDARD_DEVIATION 10 | 42 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants | 126 Participants | 120 Participants | 368 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 24 Participants | 33 Participants | 93 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 82 Participants | 97 Participants | 84 Participants | 263 Participants |
| Region of Enrollment United States | 123 Participants | 128 Participants | 124 Participants | 375 Participants |
| Sex: Female, Male Female | 41 Participants | 62 Participants | 48 Participants | 151 Participants |
| Sex: Female, Male Male | 82 Participants | 66 Participants | 76 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 123 | 0 / 128 | 0 / 124 |
| other Total, other adverse events | 0 / 123 | 0 / 128 | 0 / 124 |
| serious Total, serious adverse events | 5 / 123 | 4 / 128 | 2 / 124 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples | 80 percentage of urine samples |
| Buprenorphine Adherence Only | Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples | 84 percentage of urine samples |
| Control | Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples | 78 percentage of urine samples |
p-value: =0.2295% CI: [0.719, 4.195]Regression, Logistic
p-value: =0.93895% CI: [0.435, 2.461]Regression, Logistic
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples | 83 percentage of urine samples |
| Buprenorphine Adherence Only | Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples | 85 percentage of urine samples |
| Control | Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples | 80 percentage of urine samples |
p-value: =0.20295% CI: [0.733, 4.336]Regression, Logistic
p-value: =0.47495% CI: [0.571, 3.336]Regression, Logistic
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine Adherence and Opiate Abstinence | Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine | 16.12 percentage of participants |
| Buprenorphine Adherence Only | Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine | 16.28 percentage of participants |
| Control | Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine | 18.82 percentage of participants |
p-value: =0.32895% CI: [0.299, 1.497]Regression, Logistic
p-value: =0.43595% CI: [0.322, 1.627]Regression, Logistic