Improving Treatment Outcomes for Prescription Opioid Dependence

Summary

Overall, this proposal seeks to improve treatment strategies for the significant public health problem of prescription opioid dependence by determining whether gabapentin, a non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will be effective in ameliorating withdrawal symptoms, craving and illicit drug use in prescription opioid dependent participants undergoing a 10-day detoxification from buprenorphine. In addition, the acceptability and feasibility of transitioning to depot naltrexone therapy will also be determined. If successful, this study would provide data to support further development of gabapentin as a pharmacological tool for improved outcomes during opioid detoxification as well as an integrated outpatient approach for treating prescription opioid dependence.

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Arkansas

  lead OTHER

Principal Investigators

• Alison Oliveto, PhD · University of Arkansas

• Michael Mancino, MD · University of Arkansas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2021-05-25

Completion

2021-05-31

FDA Drug

Yes

Countries

• United States

Study Locations