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Abuse Potential of Buprenorphine/Naloxone

This study has been terminated.
(Funding ended for the study)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00149539
First received: September 6, 2005
Last updated: July 9, 2007
Last verified: July 2007

September 6, 2005
July 9, 2007
June 2004
Not Provided
  • 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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Opioid-Related Disorders
Drug: Buprenorphine/naloxone
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
January 2006
Not Provided

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149539
NIDA-08045-7, R01-08045-7, DPMC
No
Not Provided
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