Status:
COMPLETED
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose respon...
Detailed Description
1\) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form
Eligibility Criteria
Inclusion Criteria:
M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria:
Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
Key Trial Info
Start Date :
October 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1999
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00000320
Start Date
October 1 1997
End Date
August 1 1999
Last Update
January 12 2017
Active Locations (1)
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1
Friends Research Institute
Los Angeles, California, United States, 90025