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Buprenorphine and Naloxone Combination Study - 10

This study has been completed.
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 18, 2001
Last updated: January 11, 2017
Last verified: August 1998
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-Blind
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.

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

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
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Please refer to this study by its identifier: NCT00015288

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
Principal Investigator: John Rotrosen, M.D. New York MDRU
  More Information Identifier: NCT00015288     History of Changes
Other Study ID Numbers: NIDA-5-0013-10
Study First Received: April 18, 2001
Last Updated: January 11, 2017

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Central Nervous System Depressants
Analgesics processed this record on May 24, 2017