Improving Treatment Outcomes for Prescription Opioid Dependence

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

May 25, 2021

Study Completion Date

May 31, 2021

Conditions
Drug Dependence
Interventions
DRUG

Gabapentin

N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detoxification and transition to depot naltrexone.

DRUG

Buprenorphine

All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.

DRUG

Clonidine

All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.

DRUG

Naltrexone (oral)

All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)

DRUG

Naltrexone (depot)

All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.

DRUG

Placebo

Microcrystalline cellulose

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of Arkansas

OTHER

NCT02543944 - Improving Treatment Outcomes for Prescription Opioid Dependence | Biotech Hunter | Biotech Hunter