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Treatment Study: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC) (ARC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698737
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : November 22, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University

Brief Summary:
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 or disease
Heroin Dependence Opioid-Related Disorders Cocaine Abuse or Dependence

Detailed Description:

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 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.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)
Study Start Date : April 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heroin dependent and Cocaine abuse or dependent research volunteers.

Inclusion Criteria:

  • Male or non-pregnant and non-lactating females between 18-55 years of age who are seeking treatment for their drug use.
  • Females of childbearing potential are eligible to participate if using an acceptable method of birth control.
  • All participants must be free from any significant clinical abnormalities based on medical history, physical examination, ECG, and screening laboratory tests.
  • Participants must weigh at least 50kg (110lbs).
  • Participants must meet DSM-IV criteria for current Cocaine Abuse or Dependence, and possibly Opioid Dependence, and provide a cocaine positive (and, if opioid dependent, opioid positive) urine sample.
  • Participants will not be excluded if they meet DSM-IV criteria for current Alcohol or Sedative Abuse (but they will be excluded for current Alcohol or Sedative Dependence).
  • Participants must not be under the influence of alcohol (BAL <.002) and sign informed consent during screening.

Exclusion Criteria:

  • Volunteers will not be eligible for this study if they present with psychiatric illness, neurological disease, cardiovascular disease, pulmonary disease, systemic disease, other current substance dependence (except cocaine, heroin or nicotine).
  • If they are cognitively impaired, currently being treated for Cocaine or Opioid Dependence, using prohibited medications, or females who are pregnant, lactating, or if heterosexually active not using medically approved birth control measures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698737

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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Mark Greenwald, PhD Wayne State University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark Greenwald, PhD, Principal Investigator, Wayne State University Identifier: NCT00698737     History of Changes
Other Study ID Numbers: NIDA 022243-2
R01DA022243 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Keywords provided by Mark Greenwald, PhD, Wayne State University:
Additional relevant MeSH terms:
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Opioid-Related Disorders
Cocaine-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anesthetics, Local
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Autonomic Agents