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NCT00000318 Clinical Trial

Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

Substance-Related Disorders Clinical Trial

Official title:
Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000318
Other study ID # NIDA-09803-1
Secondary ID R01-09803-1
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated January 11, 2017
Start date December 1994
Est. completion date August 2007

Study information
Verified date December 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.

Recruitment information / eligibility
Status Completed
Enrollment 202
Est. completion date August 2007
Est. primary completion date March 2004
Accepts healthy volunteers No
Gender All
Age group 21 Years to 55 Years
Eligibility Please contact site for information.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine
Experimental Maintenance treatment with daily medication Experimental Maintenance treatment with thrice-weekly medication

Locations
Country Name City State
United States APT Residential Services Division New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opioid and cocaine use 26 weeks No
Primary Social and psychological functioning 26 weeks No
Primary AIDS risk behavior 26 weeks No
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