Trial Outcomes & Findings for Nalrexone Facilitated Discontinuation of Buprenorphine (NCT NCT01895036)

Results Overview

Number of individuals successfully discontinuing buprenorphine during the inpatient phase and through follow-up.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

7 weeks

Results posted on

2018-06-15

Participant milestones
Measure	Naltrexone PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone Naltrexone
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Nalrexone Facilitated Discontinuation of Buprenorphine

Baseline characteristics by cohort
Measure	Naltrexone n=6 Participants PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone Naltrexone
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.2 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

Timeframe: 7 weeks

Number of individuals successfully discontinuing buprenorphine during the inpatient phase and through follow-up.

Outcome measures
Measure	Naltrexone n=6 Participants PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone Naltrexone
Successful Discontinuation of Buprenorphine	6 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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