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NCT00015171 Clinical Trial

Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

Substance-Related Disorders Clinical Trial

Official title:
CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00015171
Other study ID # NIDA-5-0013-1
Secondary ID Y01-5-0013-1
Status Completed
Phase Phase 3
First received April 18, 2001
Last updated January 13, 2017
Start date April 1996
Est. completion date June 1997

Study information
Verified date January 1999
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Description:

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 1997
Est. primary completion date May 1997
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion Criteria:

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine/naloxone

Locations
Country Name City State
United States New York MDRU New York New York

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) New York MDRU

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Craving
Primary Drug use
Primary Retention
Primary Opioid withdrawal
Primary Subjective rating
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