Buprenorphine Combination Tablet Feasibility - 1

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine Combination Tablet Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000298
• Other study ID #: NIDA-09260-1
• Secondary ID: P50-09260-1
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: August 16, 2005
• Start date: August 1995

Study information

• Verified date: January 1996
• Source: National Institute on Drug Abuse (NIDA)
• 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 determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• 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, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Buprenorphine/nalaxone cmbination tablet: First clinical experience (j. Add Dis 1997, in press). Buprenorphine/naloxone combination tablet: First clincial experience (J Add Dis 1997, in press).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal symptoms
Primary	Opiate use
Primary	Opiate craving