Trial Outcomes & Findings for Contingency Management to Enhance Office-Based Buprenorphine Treatment (NCT NCT04024059)
NCT ID: NCT04024059
Last Updated: 2025-03-12
Results Overview
This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
375 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
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
|
Buprenorphine Adherence Only
Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence
|
Control
Participants will not receive any intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
128
|
124
|
|
Overall Study
COMPLETED
|
112
|
126
|
119
|
|
Overall Study
NOT COMPLETED
|
11
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contingency Management to Enhance Office-Based Buprenorphine Treatment
Baseline characteristics by cohort
| Measure |
Buprenorphine Adherence and Opiate Abstinence
n=123 Participants
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
|
Buprenorphine Adherence Only
n=128 Participants
Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence
|
Control
n=124 Participants
Participants will not receive any intervention.
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
370 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 11 • n=5 Participants
|
42 years
STANDARD_DEVIATION 10 • n=7 Participants
|
41 years
STANDARD_DEVIATION 10 • n=5 Participants
|
42 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
368 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
263 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
123 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThis will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.
Outcome measures
| Measure |
Buprenorphine Adherence and Opiate Abstinence
n=369 urine samples
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
|
Buprenorphine Adherence Only
n=384 urine samples
Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence
|
Control
n=372 urine samples
Participants will not receive any intervention.
|
|---|---|---|---|
|
Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples
|
80 percentage of urine samples
|
84 percentage of urine samples
|
78 percentage of urine samples
|
PRIMARY outcome
Timeframe: 12 weeksThis will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.
Outcome measures
| Measure |
Buprenorphine Adherence and Opiate Abstinence
n=369 urine samples
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
|
Buprenorphine Adherence Only
n=384 urine samples
Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence
|
Control
n=372 urine samples
Participants will not receive any intervention.
|
|---|---|---|---|
|
Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples
|
83 percentage of urine samples
|
85 percentage of urine samples
|
80 percentage of urine samples
|
SECONDARY outcome
Timeframe: 12 weeksThis is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.
Outcome measures
| Measure |
Buprenorphine Adherence and Opiate Abstinence
n=123 Participants
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
|
Buprenorphine Adherence Only
n=128 Participants
Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence
|
Control
n=124 Participants
Participants will not receive any intervention.
|
|---|---|---|---|
|
Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine
|
16.12 percentage of participants
|
16.28 percentage of participants
|
18.82 percentage of participants
|
Adverse Events
Buprenorphine Adherence and Opiate Abstinence
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Buprenorphine Adherence Only
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine Adherence and Opiate Abstinence
n=123 participants at risk
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
|
Buprenorphine Adherence Only
n=128 participants at risk
Participants will receive financial incentives for buprenorphine use.
Contingency Management for adherence: Incentives contingent on buprenorphine adherence
|
Control
n=124 participants at risk
Participants will not receive any intervention.
|
|---|---|---|---|
|
General disorders
Breast Cancer
|
0.00%
0/123 • 12 weeks
|
0.78%
1/128 • Number of events 1 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
|
General disorders
Assault
|
0.00%
0/123 • 12 weeks
|
0.78%
1/128 • Number of events 1 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Covid
|
0.00%
0/123 • 12 weeks
|
0.78%
1/128 • Number of events 1 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
|
Surgical and medical procedures
endocarditis with heart surgery for pace maker
|
0.81%
1/123 • Number of events 1 • 12 weeks
|
0.00%
0/128 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
|
Infections and infestations
Infection
|
1.6%
2/123 • Number of events 2 • 12 weeks
|
0.00%
0/128 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
|
Psychiatric disorders
Psychiatric
|
0.81%
1/123 • Number of events 1 • 12 weeks
|
0.00%
0/128 • 12 weeks
|
0.81%
1/124 • Number of events 1 • 12 weeks
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
0.00%
0/123 • 12 weeks
|
0.00%
0/128 • 12 weeks
|
0.81%
1/124 • Number of events 1 • 12 weeks
|
|
Blood and lymphatic system disorders
blood clot in lungs
|
0.81%
1/123 • Number of events 1 • 12 weeks
|
0.00%
0/128 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
|
Nervous system disorders
seizure
|
0.00%
0/123 • 12 weeks
|
0.78%
1/128 • Number of events 1 • 12 weeks
|
0.00%
0/124 • 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Silverman, Ph.D.
Johns Hopkins University School of Medicine
Phone: 4436176051
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place