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Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

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ClinicalTrials.gov Identifier: NCT00000320
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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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."

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine formulation: liquid vs. tablet Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution
Study Start Date : October 1997
Actual Primary Completion Date : August 1999
Actual Study Completion Date : August 1999

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1; liquid formulation
liquid formulation
 Drug: Buprenorphine formulation: liquid vs. tablet
random assignment to liquid buprenorphine or tablet buprenorphine
Other Names:
  • Subutex
  • Suboxone
Active Comparator: 2; tablet formulation
tablet formulation
 Drug: Buprenorphine formulation: liquid vs. tablet
random assignment to liquid buprenorphine or tablet buprenorphine
Other Names:
  • Subutex
  • Suboxone


Outcome Measures
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Primary Outcome Measures :
  1. blood level [ Time Frame: across study duration ]

Secondary Outcome Measures :
  1. drug use [ Time Frame: across study duration ]
  2. craving [ Time Frame: across study duration ]
  3. withdrawal symptoms [ Time Frame: across study duration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000320


Locations
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United States, California
Friends Research Institute
Los Angeles, California, United States, 90025
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
More Information
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Responsible Party: Walter Ling, M.D., Friends Research Institute
ClinicalTrials.gov Identifier: NCT00000320    
Other Study ID Numbers: NIDA-10068-1
R01-10068-1
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2009
Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists