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

Completed

Conditions studied: Heroin Dependence, Opioid-Related Disorders, Cocaine Abuse or Dependence

In brief

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.

Key facts

Study ID

NCT00698737

Run by

Wayne State University

People needed

22

Starts

2008-04-01

Expected to finish

2012-11-01

Last updated by the study team

2012-11-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wayne State University — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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