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Sponsors and Collaborators: |
Columbia University Schering-Plough |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00710385 |
The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Condition | Intervention | Phase |
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Opioid-Related Disorders |
Drug: heroin, naloxone, buprenorphine, buprenorphine/naloxone |
Phase III |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Reinforcing Effects of Intravenous Buprenorphine Versus Buprenorphine/Naloxone in Buprenorphine-Maintained Intravenous Drug Users (P05207) |
Estimated Enrollment: | 12 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Challenge Doses: Experimental |
Drug: heroin, naloxone, buprenorphine, buprenorphine/naloxone
Dosage form: intravenous Dosage: heroin (25 mg), naloxone (0.5-4 mg), buprenorphine (2-16 mg), buprenorphine/naloxone (2/0.5-16/4 mg)
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Drug dependence is a major international public health problem of which opioid dependence, notably involving heroin, is a major component. Opioid dependence affects an estimated 13 million injection drug users (IDUs) worldwide. The high health service costs for the treatment of diseases related to non-medical drug use and the high cost to society of drug-related behavior have prompted researchers to seek new medications and treatment strategies for opioid dependence. Buprenorphine, a mu-opiate receptor partial agonist and kappa-opiate receptor antagonist, is one such new medication that has had a significant role in expanding access to effective opioid dependence treatment. It is available as Subutex (buprenorphine alone) or Suboxone (a combination of buprenorphine and naloxone). Although it is commonly believed that the abuse potential of buprenorphine is low, numerous countries have reported illicit diversion of buprenorphine and a growing population of buprenorphine abusers. Theoretically, Suboxone would have lower abuse potential. When used sublingually, as prescribed, the amount of naloxone absorbed is negligible. However, if a patient crushes the tablet and attempts to inject or sniff the medication, the naloxone will become effective as an opioid antagonist and may precipitate withdrawal signs and symptoms in individuals dependent on full opioid agonists and/or attenuate the euphoric effects of the buprenorphine that is also contained in the medication. To date, few laboratory studies have evaluated the abuse liability of buprenorphine in humans using a drug self-administration protocol. We are proposing to evaluate the abuse potential of intravenous (IV) buprenorphine compared to IV buprenorphine/naloxone in buprenorphine-maintained injection drug users (IDUs), incorporating self-administration procedures with other measures of opioid effects. The proposed study will investigate the conditions that affect the self-administration of IV buprenorphine by buprenorphine abusers. The primary aim of the study is to compare the reinforcing effects of IV buprenorphine and IV buprenorphine/naloxone in IDUs maintained on different doses of sublingual buprenorphine (2, 8, and 24 mg/day). Secondary aims of the study are to compare the subjective, performance and physiological effects of IV buprenorphine and IV buprenorphine/naloxone. IV-administered placebo (saline), naloxone alone, and heroin alone will be tested as neutral, negative, and positive control conditions, respectively. Participants (N=12 completers) will reside on an inpatient unit (the General Clinical Research Unit, GCRU) during a 7 to 8-week study. This research will provide useful information for clinicians treating opioid dependent individuals with buprenorphine, and importantly, will provide information about the abuse potential and effects of buprenorphine on multiple measures of human functioning.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Phillip Saccone, B.S. | 212-543-5319 | saccone@pi.cpmc.columbia.edu |
Contact: Joseph Lazar, B.S. | 212-543-5319 | lazarjo@pi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute/Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Maria A Sullivan, MD/PhD 212-543-6525 sulliva@pi.cpmc.columbia.edu | |
Contact: Suzanne Vosburg, PhD 212-543-6192 vosburg@pi.cpmc.columbia.edu | |
Sub-Investigator: Maria A Sullivan, MD/PhD |
Principal Investigator: | Sandra D Comer, PhD | Columbia University/New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute and Columbia University ( Herbert D. Kleber, M.D. ) |
Study ID Numbers: | IRB5518 |
Study First Received: | June 11, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00710385 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heroin Narcotic Antagonists Disorders of Environmental Origin Central Nervous System Depressants Narcotics Opioid-Related Disorders Naloxone |
Buprenorphine Mental Disorders Substance-Related Disorders Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
Heroin Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Naloxone |
Buprenorphine Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |