Trial Outcomes & Findings for A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders (NCT NCT03232346)
NCT ID: NCT03232346
Last Updated: 2022-11-07
Results Overview
Percent of patients retained in treatment and abstinent from opioids at the end of the trial
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
Week 25
Results posted on
2022-11-07
Participant Flow
Participant milestones
| Measure |
Regimen 1
Rapid Monday to Friday oral naltrexone-induction procedure
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol
|
Regimen 2
5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg
Buprenorphine: 5-week buprenorphine taper
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
Baseline characteristics by cohort
| Measure |
Regimen 1
n=6 Participants
Rapid Monday to Friday oral naltrexone-induction procedure
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol
|
Regimen 2
n=5 Participants
5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg
Buprenorphine: 5-week buprenorphine taper
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
41.7 years
n=99 Participants
|
49.6 years
n=107 Participants
|
45.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 25Population: Participants who were randomized to one of the two study regimens
Percent of patients retained in treatment and abstinent from opioids at the end of the trial
Outcome measures
| Measure |
Regimen 1
n=6 Participants
Rapid Monday to Friday oral naltrexone-induction procedure
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol
|
Regimen 2
n=5 Participants
5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg
Buprenorphine: 5-week buprenorphine taper
|
|---|---|---|
|
Percent of Patients Successfully Transitioned Off Buprenorphine
|
2 Participants
|
3 Participants
|
Adverse Events
Regimen 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen 2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen 1
n=6 participants at risk
Rapid Monday to Friday oral naltrexone-induction procedure
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol
|
Regimen 2
n=5 participants at risk
5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg
Buprenorphine: 5-week buprenorphine taper
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hospitalization for pneumonia
|
0.00%
0/6 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place