Trial Outcomes & Findings for Buprenorphine Treatment Engagement and Overdose Prevention (NCT NCT03677986)
NCT ID: NCT03677986
Last Updated: 2024-02-20
Results Overview
This will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-02-20
Participant Flow
Participants were recruited via community agencies that served the target population and a referral system in which study participants were paid for successfully referring others to the study. Interested individuals completed a brief phone interview. Potentially eligible participants were invited for a full in-person interview.
Participant milestones
| Measure |
Usual Care
Participants in this group will be referred to receive office-based buprenorphine treatment
|
Video DOT+
Participants in this group will be referred to receive office-based buprenorphine treatment and will receive financial incentives for taking their daily buprenorphine dose.
Video Directly Observed Therapy (DOT)+: Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buprenorphine Treatment Engagement and Overdose Prevention
Baseline characteristics by cohort
| Measure |
Usual Care
n=20 Participants
Participants in this group will be referred to receive office-based buprenorphine treatment
|
Video DOT+
n=21 Participants
Participants in this group will be referred to receive office-based buprenorphine treatment and will receive financial incentives for taking their daily buprenorphine dose.
Video DOT+: Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
|
Total
n=41 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
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Self-reported methadone use
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThis will be assessed by the percentage of buprenorphine-positive urine samples during the 24-week intervention.
Outcome measures
| Measure |
Video DOT+
n=21 Participants
Participants in this group will be referred to receive office-based buprenorphine treatment and will receive financial incentives for taking their daily buprenorphine dose.
Video DOT+: Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
|
Usual Care
n=20 Participants
Participants in this group will be referred to receive office-based buprenorphine treatment
|
|---|---|---|
|
Buprenorphine Treatment Adherence
|
16.1 percentage of urine samples
Standard Deviation 3.7
|
19.7 percentage of urine samples
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: 24 weeksThis will be assessed by the percentage of participants who get linked to buprenorphine treatment during the 24-week intervention
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video DOT+
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Silverman, Professor
Johns Hopkins University School of Medicine
Phone: 4105502694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place