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Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
This study has been completed.
Study NCT00000320   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 20, 1999   Last Updated: January 5, 2009   History of Changes

September 20, 1999
January 5, 2009
October 1997
August 1999   (final data collection date for primary outcome measure)
blood level [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
  • Craving
  • Drug use
  • Withdrawal symptoms
Complete list of historical versions of study NCT00000320 on ClinicalTrials.gov Archive Site
  • drug use [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
  • craving [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
  • withdrawal symptoms [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
Same as current
 
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution

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."

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

Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics Study
Opioid-Related Disorders
Drug: Buprenorphine formulation: liquid vs. tablet
  • Active Comparator: liquid formulation
  • Active Comparator: tablet formulation
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
August 1999
August 1999   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000320
Walter Ling, M.D., Friends Research Institute
NIDA-10068-1, R01-10068-1
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP