Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Wayne State University |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00429767 |
The purpose of this study is to determine whether maintenance on different oral doses of sustained release d-amphetamine (SR-AMP) combined with constant-dose sublingual buprenorphine (BUP) is safe and well tolerated and decreases self-administration of cocaine alone or combined with hydromorphone (HYD). Secondary aims are to determine whether SR-AMP attenuates the subjective and physiological effects of cocaine during drug sampling periods prior to choice opportunities.
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine: Study 1 |
Estimated Enrollment: | 16 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Heroin abusers also frequently abuse cocaine, and concurrent use of these drugs is associated with more severe drug dependence and associated psychiatric and medical problems, greater risk for HIV infection, worse drug abuse treatment outcome, and creates a public health burden. New methods and solutions are needed for this problem.
While human laboratory models exist to study choice of cocaine or opioids individually, studies have not examined choice of cocaine alone or cocaine/opioid combinations by heroin dependent individuals, nor have there been interventions to reduce such drug use. We recently developed a sensitive laboratory-based choice progressive ratio procedure to study drug-seeking behavior for opioids. This study will extend this procedure, in the form of drug combination vs. money choices, to obtain a novel human laboratory model of cocaine/opioid abuse. The purpose of this study is to determine whether maintenance on different doses of sustained release d-amphetamine (SR-AMP) combined with constant-dose buprenorphine (BUP) is safe and well tolerated and decreases self-administration of cocaine alone or combined with HYD. Secondary aims are to determine whether SR-AMP attenuates the subjective and physiological effects of cocaine during drug sampling periods prior to choice opportunities.
One goal of this new study is to develop a human laboratory model of polydrug abuse by allowing participants (who abuse both heroin and cocaine) to choose between drug combinations or money. The second goal of this study is to develop medication treatments to reduce cocaine use by opioid dependent individuals.
Participants in this observational study will take part in multiple trials in which they have the opportunity to choose between drug combinations (cocaine alone or combined with HYD; relative to HYD alone and dual placebo) or money. On the morning of each session, prior to the choice procedure, participants will receive a sample of the drug dose that can be chosen. Participants will be asked to attend to the effects produced by the drug combination because they will be able to choose this relative to money in the choice task in the afternoon session. During the choice procedure, participants will have 12 opportunities to choose either drug or money. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout the study. Self-report questionnaires will be completed at different times during the study. Participants will be maintained on a constant dose of BUP throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study completion. During the experiment they will be maintained on different doses of SR-AMP and on a constant dose of BUP.
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, 48207 | |
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, R01 DA-022243, DPMCDA |
Study First Received: | January 30, 2007 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00429767 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Opioid Cocaine Drug Self Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Heroin Narcotic Antagonists Disorders of Environmental Origin Anesthetics Opioid-Related Disorders Buprenorphine Dopamine Mental Disorders Substance-Related Disorders Vasoconstrictor Agents Analgesics |
Cocaine Analgesics, Opioid Cocaine-Related Disorders Heroin Dependence Central Nervous System Depressants Narcotics Cardiovascular Agents Anesthetics, Local Methamphetamine Dextroamphetamine Amphetamine Dopamine Agents Peripheral Nervous System Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Narcotic Antagonists Anesthetics Disorders of Environmental Origin Opioid-Related Disorders Buprenorphine Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders |
Vasoconstrictor Agents Analgesics Cocaine Analgesics, Opioid Cocaine-Related Disorders Heroin Dependence Central Nervous System Depressants Narcotics Cardiovascular Agents Anesthetics, Local Pharmacologic Actions Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |