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Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution - 1

This study is ongoing, but not recruiting participants.
Study NCT00000320.   Last updated on June 23, 2005.   Information provided by National Institute on Drug Abuse (NIDA)

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Descriptive Information Fields
Brief Title  Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution - 1
Official Title  Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution
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 response curve for tablet is equal to liquid form."

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

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Double-Blind, Crossover Assignment
Primary Outcome Measure  Craving
Drug use
Withdrawal symptoms
Secondary Outcome Measure 
Condition  Opioid-Related Disorders
Intervention  Drug: Buprenorphine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  0
Start Date  October 1997
Completion Date
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.

Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000320
Organization ID NIDA-10068-1
Secondary IDs †† R01-10068-1
Study Sponsor  National Institute on Drug Abuse (NIDA)
Collaborators ††
Investigators 
Principal Investigator:     Walter Ling, M.D.     Friends Research Institute, Inc.    
Information Provided By National Institute on Drug Abuse (NIDA)
Verification Date October 1997
First Received Date  September 20, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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