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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University
ClinicalTrials.gov Identifier:
NCT00698737
First received: June 13, 2008
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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
Heroin Dependence
Opioid-Related Disorders
Cocaine Abuse or Dependence

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Enrollment: 22
Study Start Date: April 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heroin dependent and Cocaine abuse or dependent research volunteers.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698737

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Mark Greenwald, PhD Wayne State University
  More Information

No publications provided

Responsible Party: Mark Greenwald, PhD, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT00698737     History of Changes
Other Study ID Numbers: NIDA 022243-2, R01DA022243, DPMCDA
Study First Received: June 13, 2008
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Wayne State University:
Opioid
Cocaine

Additional relevant MeSH terms:
Cocaine-Related Disorders
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Amphetamine
Cocaine
Buprenorphine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Analgesics, Opioid
Analgesics
Sensory System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on April 17, 2014