Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2

Conditions: Opioid-Related Disorders

Treatments: Drug: Buprenorphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000299

P50-09260-2

P50DA009260 (U.S. NIH Grant/Contract)

NIDA-09260-2

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

buprenorphine

Active Comparator group

Description:

depot buprenorphine

Treatment:

Drug: Buprenorphine

buprenorphine and ultra-low dose naloxone

Experimental group

Description:

depot buprenorphine and naloxone

Treatment:

Drug: Buprenorphine