CompletedNot Applicable

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

United States22 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00698737

SponsorWayne State University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Heroin Dependence trials