ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Liquid vs. Tablet Buprenorphine - 6

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.
ClinicalTrials.gov Identifier: NCT00000341
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine
Study Start Date : August 1996
Actual Study Completion Date : August 2000

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Subjective and observer rater physiological effects of bup


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:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.


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): NCT00000341


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.

ClinicalTrials.gov Identifier: NCT00000341     History of Changes
Other Study ID Numbers: NIDA-3-0010-6
Y01-3-0010-6
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008

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