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Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000320
First Posted: September 21, 1999
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
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 Intervention Phase
Opioid-Related Disorders Drug: Buprenorphine formulation: liquid vs. tablet Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Secondary Outcome Measures:
  • drug use [ Time Frame: across study duration ]
  • craving [ Time Frame: across study duration ]
  • withdrawal symptoms [ Time Frame: across study duration ]

Enrollment: 120
Study Start Date: October 1997
Study Completion Date: August 1999
Primary Completion Date: August 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
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
United States, California
Friends Research Institute
Los Angeles, California, United States, 90025
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
  More Information

Responsible Party: Walter Ling, M.D., Friends Research Institute
ClinicalTrials.gov Identifier: NCT00000320     History of Changes
Other Study ID Numbers: NIDA-10068-1
R01-10068-1
First Submitted: September 20, 1999
First Posted: September 21, 1999
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:
Opioid-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