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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000344
Other study ID # NIDA-3-0010-9
Secondary ID Y01-3-0010-9
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated January 11, 2017
Est. completion date August 2000

Study information

Verified date August 2008
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 the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2000
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


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, 

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