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Buprenorphine and Naloxone Combination Study - 10

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00015288
First Posted: April 18, 2001
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.
Collaborator:
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Condition Intervention Phase
Heroin Dependence Opioid-Related Disorders Drug: Buprenorphine/naloxone Phase 1

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: PK0496 Pharmacokinetics of Buprenorphine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Physiological measures
  • Measurements of buprenorphine and naloxone in plasma
  • Subjective symptoms measures

Estimated Enrollment: 0
Study Start Date: November 1996
Detailed Description:
The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.

Exclusion Criteria:

LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.

  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): NCT00015288


Locations
United States, New York
New York MDRU
New York, New York, United States, 10010
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
New York MDRU
Investigators
Principal Investigator: John Rotrosen, M.D. New York MDRU
  More Information

ClinicalTrials.gov Identifier: NCT00015288     History of Changes
Other Study ID Numbers: NIDA-5-0013-10
Y01-5-0013-10
First Submitted: April 18, 2001
First Posted: April 18, 2001
Last Update Posted: January 12, 2017
Last Verified: August 1998

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists