Trial Outcomes & Findings for Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals (NCT NCT03711318)

Last Updated: 2022-12-22

Results Overview

Number of patients who received the first Vivitrol injection among those who initiated the induction

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-12-22

Participant milestones
Measure	Short-term Treatment With Buprenorphine Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of XR-naltrexone
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Withdrawal data not reported

Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

Baseline characteristics by cohort
Measure	Short-term Treatment With Buprenorphine n=8 Participants Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of XR-naltrexone
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 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	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

Timeframe: 12 weeks

Number of patients who received the first Vivitrol injection among those who initiated the induction

Outcome measures
Measure	Short-term Treatment With Buprenorphine n=8 Participants Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of treatment with XR-naltrexone
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol	3 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Short-term Treatment With Buprenorphine n=8 participants at risk Short-term treatment with buprenorphine Buprenorphine/naloxone: 3 week treatment with buprenorphine/naloxone followed by initiation of treatment with Vivitrol
Psychiatric disorders depressive symptoms	12.5% 1/8 • Number of events 1 • 12 weeks of treatment

NYS Psychiatric Institute

Phone: 646-774-6155