Trial Outcomes & Findings for Buprenorphine Treatment for Opioid Dependence (NCT NCT02187198)
NCT ID: NCT02187198
Last Updated: 2023-03-10
Results Overview
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
Weeks 1-12
Results posted on
2023-03-10
Participant Flow
Participant milestones
| Measure |
Buprenorphine Low Dose
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Buprenorphine
|
Buprenorphine High Dose
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Buprenorphine
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Buprenorphine Low Dose
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Buprenorphine
|
Buprenorphine High Dose
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Buprenorphine
|
|---|---|---|
|
Overall Study
did not show up for appointment and did not return calls after week 9
|
1
|
0
|
|
Overall Study
did not show up for appointment and did not return calls after week 11
|
0
|
1
|
Baseline Characteristics
Buprenorphine Treatment for Opioid Dependence
Baseline characteristics by cohort
| Measure |
Buprenorphine Low Dose
n=5 Participants
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Buprenorphine
|
Buprenorphine High Dose
n=4 Participants
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Buprenorphine
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.60 years
STANDARD_DEVIATION 13.07 • n=99 Participants
|
43.25 years
STANDARD_DEVIATION 16.72 • n=107 Participants
|
40.67 years
STANDARD_DEVIATION 14.01 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
PRIMARY outcome
Timeframe: Weeks 1-12Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Outcome measures
| Measure |
Buprenorphine Low Dose
n=5 Participants
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Buprenorphine
|
Buprenorphine High Dose
n=4 Participants
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Buprenorphine
|
|---|---|---|
|
Urine Toxicology for Opiate Use
Negative urine toxicology for opiates
|
2 Participants
|
4 Participants
|
|
Urine Toxicology for Opiate Use
One positive urine toxicology for opiates during 12 week study
|
2 Participants
|
0 Participants
|
|
Urine Toxicology for Opiate Use
Two positive urine toxicology for opiates during 12 week study
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-12Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Outcome measures
| Measure |
Buprenorphine Low Dose
n=5 Participants
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Buprenorphine
|
Buprenorphine High Dose
n=4 Participants
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Buprenorphine
|
|---|---|---|
|
Urine Toxicology
More than 6 positive urine toxicology for cannabinoids during 12 week study
|
1 Participants
|
1 Participants
|
|
Urine Toxicology
Negative urine toxicology for cannabinoids
|
3 Participants
|
3 Participants
|
|
Urine Toxicology
Less than 6 positive urine toxicology for cannabinoids during 12 week study
|
1 Participants
|
0 Participants
|
Adverse Events
Buprenorphine Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buprenorphine High Dose
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
Elizabeth Ralevski, PhD
Yale University School of Medicine, Department of Psychiatry
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place