Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

Opioid-Related Disorders Clinical Trial

Official title:

Rapid Opiate Detoxification & Naltrexone Induction Using Bup.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000299
• Other study ID #: NIDA-09260-2
• Secondary ID: P50DA009260P50-0
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 27, 2016
• Start date: October 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate craving	opiate craving is measured on each test day.	10 test days	No
Primary	Opiate withdrawal symptoms	opiate withdrawal symptoms are documented for each test day	10 test days	No