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Trial record 39 of 186 for:    BUPRENORPHINE AND NALOXONE

Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

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. Identifier: NCT00134914
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine Not Applicable

Detailed Description:

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.

This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals
Study Start Date : August 1996
Actual Primary Completion Date : April 1998
Actual Study Completion Date : May 1998

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Buprenorphine
    single doses given by sublingual and parenteral routes

Primary Outcome Measures :
  1. Opioid agonist rating [ Time Frame: up to one day ]
  2. opiate withdrawal [ Time Frame: up to one day ]
  3. physiologic measures [ Time Frame: up to one day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Currently opioid dependent
  • In good health, as determined by a pre-participation medical examination
  • Seeking and eligible for methadone maintenance or detoxification treatment

Exclusion Criteria:

  • Significant medical or psychiatric illness, other than drug dependence

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 identifier (NCT number): NCT00134914

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United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Eric C. Strain, MD Johns Hopkins University

Publications of Results:
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Responsible Party: Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine Identifier: NCT00134914     History of Changes
Other Study ID Numbers: NIDA-08045-4
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 2008
Keywords provided by National Institute on Drug Abuse (NIDA):
opiate dependence
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists