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Abuse Potential of Buprenorphine/Naloxone

This study has been terminated.
(Funding ended for the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149539
First Posted: September 8, 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.
Collaborator:
Johns Hopkins University
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 determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Condition Intervention Phase
Opioid-Related Disorders Drug: Buprenorphine/naloxone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone

Resource links provided by NLM:


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

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

Enrollment: 12
Study Start Date: June 2004
Study Completion Date: January 2006
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 determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone.

Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

  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:   No
Criteria

Inclusion Criteria:

  • Actively abusing illegal opioids
  • Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry
  • Meets DSM-IV criteria for opioid dependence

Exclusion Criteria:

  • Significant medical problems (e.g., insulin dependent diabetes mellitus)
  • Non-substance use psychiatric disorders (e.g., schizophrenia)
  • Seeking substance abuse treatment
  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): NCT00149539


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)
Johns Hopkins University
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00149539     History of Changes
Other Study ID Numbers: NIDA-08045-7
R01-08045-7
DPMC
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: January 12, 2017
Last Verified: July 2007

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