Abuse Potential of Buprenorphine/Naloxone

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: NCT00149539
Recruitment Status : Terminated (Funding ended for the study)
First Posted : September 8, 2005
Last Update Posted : January 12, 2017
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)

September 6, 2005
September 8, 2005
January 12, 2017
June 2004
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  • 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 ]
  • Opiate withdrawal
  • opiate agonist symptoms
  • physiologic measures
Complete list of historical versions of study NCT00149539 on Archive Site
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Abuse Potential of Buprenorphine/Naloxone
Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Opioid-Related Disorders
Drug: Buprenorphine/naloxone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2006
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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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
National Institute on Drug Abuse (NIDA)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP