Buprenorphine Combination Tablet Feasibility - 1

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000298

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief 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."

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders	Drug: Buprenorphine/naloxone	Phase 2

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Buprenorphine Combination Tablet Feasibility

Study Start Date :

Aug 1, 1995

Outcome Measures

Primary Outcome Measures

Withdrawal symptoms []
Opiate use []
Opiate craving []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.