Trial Outcomes & Findings for Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone (NCT NCT02294253)
NCT ID: NCT02294253
Last Updated: 2020-03-11
Results Overview
Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
One week after completing 30-day buprenorphone/naloxone stabilization/taper.
Results posted on
2020-03-11
Participant Flow
Participant milestones
| Measure |
Buprenorphine/Naloxone Stabilization
Participants who have initially failedoutpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,
Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
Baseline characteristics by cohort
| Measure |
Buprenorphine/Naloxone Stabilization
n=30 Participants
Participants who have initially failedoutpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,
Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week after completing 30-day buprenorphone/naloxone stabilization/taper.Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.
Outcome measures
| Measure |
Buprenorphine/Naloxone Stabilization
n=30 Participants
Participants who have initially failedoutpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,
Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone
|
|---|---|
|
Successful Induction Onto XR-NTX
|
8 Participants
|
Adverse Events
Buprenorphine/Naloxone Stabilization
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine/Naloxone Stabilization
n=30 participants at risk
Participants who have initially failed outpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,
Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone
|
|---|---|
|
Reproductive system and breast disorders
Priapism
|
3.3%
1/30 • Number of events 1 • AEs will be collected at each visit for the overall duration of the study which up to 3 months
|
Other adverse events
| Measure |
Buprenorphine/Naloxone Stabilization
n=30 participants at risk
Participants who have initially failed outpatient induction onto XR-NTX will receive buprenorphine/naloxone (BUP) on a weekly basis that they will take daily,
Buprenorphine/naloxone: 30 day oral Buprenorphine/naloxone
|
|---|---|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Number of events 2 • AEs will be collected at each visit for the overall duration of the study which up to 3 months
|
|
Gastrointestinal disorders
Decreased Appetite
|
6.7%
2/30 • Number of events 2 • AEs will be collected at each visit for the overall duration of the study which up to 3 months
|
|
Psychiatric disorders
Anxiety
|
6.7%
2/30 • Number of events 3 • AEs will be collected at each visit for the overall duration of the study which up to 3 months
|
|
General disorders
Decreased energy
|
6.7%
2/30 • Number of events 2 • AEs will be collected at each visit for the overall duration of the study which up to 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place