Status:
WITHDRAWN
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Heroin Dependence
Opioid-Related Disorders
Eligibility:
All Genders
18-62 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a...
Detailed Description
Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16m...
Eligibility Criteria
Inclusion Criteria:
Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Exclusion Criteria:
Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1997
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000327
Start Date
June 1 1997
End Date
August 1 1997
Last Update
May 4 2017
Active Locations (1)
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1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80206