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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00134875 |
Purpose
Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals. However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in non-dependent opioid abusers.
| Condition | Intervention |
|---|---|
|
Opioid-Related Disorders |
Drug: Buprenorphine/naloxone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
| Official Title: | Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers |
| Enrollment: | 9 |
| Study Start Date: | December 2000 |
| Estimated Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal. While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's agonist effects, especially if administered parenterally. The purpose of this study is to assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and buprenorphine/naloxone in non-dependent opioid abusers.
Participants will stay on a research ward and will undergo challenge sessions twice per week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological status will be recorded continuously and tasks assessing psychomotor, subjective, and objective status will be performed repeatedly.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University (BPRU) Bayview Campus | |
| Baltimore, Maryland, United States, 21224 6823 | |
| Principal Investigator: | Eric C. Strain, M.D. | Johns Hopkins University |
More Information
| Responsible Party: | Johns Hopkins University School of Medicine ( Eric C. Strain/Principal Investigator ) |
| Study ID Numbers: | NIDA-08045-3, R01-08045-3, DPMC |
| Study First Received: | August 23, 2005 |
| Last Updated: | October 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00134875 |
| Health Authority: | United States: Food and Drug Administration |
|
Buprenorphine Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Opioid-Related Disorders Naloxone |
|
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |
