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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134914
First Posted: August 25, 2005
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.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
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 Intervention
Opioid-Related Disorders Drug: Buprenorphine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Opioid agonist rating [ Time Frame: up to one day ]
  • opiate withdrawal [ Time Frame: up to one day ]
  • physiologic measures [ Time Frame: up to one day ]

Enrollment: 10
Study Start Date: August 1996
Study Completion Date: May 1998
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Buprenorphine
    single doses given by sublingual and parenteral routes
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.

  Eligibility

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
Criteria

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
  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): NCT00134914


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

Publications:
Responsible Party: Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00134914     History of Changes
Other Study ID Numbers: NIDA-08045-4
R01-08045-4
DPMC
First Submitted: August 23, 2005
First Posted: August 25, 2005
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:
Opioid-Related Disorders
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