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Buprenorphine and Naloxone Combination Study - 10

This study has been completed.
Sponsor:
Collaborator:
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00015288
First received: April 18, 2001
Last updated: August 16, 2005
Last verified: August 1998
History of Changes
  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-Blind
Primary Purpose: Treatment
Official Title: PK0496 Pharmacokinetics of Buprenorphine

Resource links provided by NLM:

MedlinePlus related topics: Heroin
U.S. FDA Resources

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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00015288     History of Changes
Other Study ID Numbers: NIDA-5-0013-10, Y01-5-0013-10
Study First Received: April 18, 2001
Last Updated: August 16, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013