Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

Phase 2

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Drug: Buprenorphine

• Registration Number: NCT00000299
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 1999-09-20
• Study First Submitted QC: 1999-09-20
• Study First Posted: 1999-09-21
• Study Start: 2008-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Males/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria

psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
buprenorphine	Buprenorphine	depot buprenorphine
buprenorphine and ultra-low dose naloxone	Buprenorphine	depot buprenorphine and naloxone

Primary Outcome Measures

Name	Time	Method
Opiate craving	10 test days	opiate craving is measured on each test day.
Opiate withdrawal symptoms	10 test days	opiate withdrawal symptoms are documented for each test day

Trial Locations

Locations (1)

Friends Research Institute; 🇺🇸 Los Angeles, California, United States