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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Wayne State University |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00698737 |
This research study takes place at Wayne State University and will take about 11 weeks to complete. This is a treatment research study for individuals who currently have cocaine abuse or dependence, and who may also have heroin dependence. The purpose of this study is to test whether oral sustained release d-amphetamine (SR-AMP) is safe and more effective than placebo for preventing relapse to cocaine use for individuals who abuse or are dependent upon cocaine. We are also interested whether, for patients who are dependent on cocaine and heroin, whether SR-AMP is safe and effective for preventing cocaine relapse in combination with buprenorphine.
Condition |
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Heroin Dependence Opioid-Related Disorders Cocaine Abuse or Dependence |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC) |
Estimated Enrollment: | 40 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Cocaine dependence, particularly in combination with heroin dependence, poses serious and substantial public health, social, and economic problems (e.g., high medical costs, crime, lost productivity). Cocaine and heroin use disorders often co-occur, and this conjunction is associated with higher rates of medical and psychiatric problems and worse drug abuse treatment outcome.
Many medications have been tested, but have failed, for treating cocaine dependence alone or in cocaine abusers who also use heroin.
This clinical trial will test whether SR-AMP is more effective than placebo for preventing relapse to cocaine use, using SR-AMP for patients with only cocaine dependence, or in combination with buprenorphine (for those patients who are also dependent on heroin).
Participants will first be an outpatient and must come to the Jefferson Avenue Research Program three times per week (e.g. Monday, Wednesday, Friday) to measure drug use and drug-related symptoms. This phase will last at least 2 weeks.
Next, participants will live on an inpatient research unit at Detroit Receiving Hospital for seven (7) consecutive nights. During the weeklong inpatient stay, in addition to receiving SR-AMP or placebo capsules, participants will begin counseling treatment to help prepare to avoid relapse after they are discharged from the inpatient unit.
After the inpatient stay, participants will then be an outpatient and come to the Jefferson Ave. Research Program daily for eight (8) weeks. Throughout all eight weeks, three urine samples will be collected each week to assess illicit drug use, and questionnaires related to drug symptoms and to assess mood and risk behaviors will be given.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Heroin dependent and Cocaine abuse or dependent research volunteers.
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Sulkowski | (313) 993-3966 | lsulkows@med.wayne.edu |
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Mark Greenwald, PhD 313-993-3965 mgreen@med.wayne.edu | |
Principal Investigator: Mark Greenwald, PhD |
Principal Investigator: | Mark Greenwald, PhD | Wayne State University |
Responsible Party: | Wayne State University ( Mark Greenwald, Ph.D. ) |
Study ID Numbers: | NIDA 022243-2 |
Study First Received: | June 13, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00698737 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Opioid Cocaine |
Cocaine-Related Disorders Methamphetamine Buprenorphine Dopamine Heroin Mental Disorders |
Heroin Dependence Substance-Related Disorders Disorders of Environmental Origin Amphetamine Cocaine Opioid-Related Disorders |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Narcotic Antagonists Anesthetics Central Nervous System Depressants Narcotics Cardiovascular Agents |
Anesthetics, Local Pharmacologic Actions Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |