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

NCT00698737 | Completed DMC

• 3 other identifiers: NIDA 022243-2R01DA022243DPMCDA
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Heroin Dependence; Opioid-Related Disorders; Cocaine Abuse or Dependence

Keywords

Opioid; Cocaine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Heroin dependent and Cocaine abuse or dependent research volunteers.

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.

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• Stoltman JJ, Woodcock EA, Lister JJ, Greenwald MK, Lundahl LH. Exploration of the telescoping effect among not-in-treatment, intensive heroin-using research volunteers. Drug Alcohol Depend. 2015 Mar 1;148:217-20. doi: 10.1016/j.drugalcdep.2015.01.010. Epub 2015 Jan 19.

  PMID: 25630964 DERIVED

MeSH Terms

Conditions

Heroin Dependence; Opioid-Related Disorders; Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mark Greenwald, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

US (1)