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Treatment Study: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), April 2009
First Received: June 13, 2008   Last Updated: April 13, 2009   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Wayne State University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00698737
  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

MedlinePlus related topics: Heroin Methamphetamine
Drug Information available for: Cocaine hydrochloride Amphetamine sulfate Buprenorphine Buprenorphine hydrochloride Amphetamine Diacetylmorphine Diacetylmorphine hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (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 at Detroit Receiving Hospital 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

Contacts
Contact: Lisa Sulkowski (313) 993-3966 lsulkows@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Mark Greenwald, PhD     313-993-3965     mgreen@med.wayne.edu    
Principal Investigator: Mark Greenwald, PhD            
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Mark Greenwald, PhD Wayne State University
  More Information

No publications provided

Responsible Party: Wayne State University ( Mark Greenwald, Ph.D. )
Study ID Numbers: NIDA 022243-2, R01 DA-022243, DPMCDA
Study First Received: June 13, 2008
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00698737     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Opioid
Cocaine

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Heroin
Narcotic Antagonists
Disorders of Environmental Origin
Anesthetics
Opioid-Related Disorders
Buprenorphine
Dopamine
Mental Disorders
Substance-Related Disorders
Vasoconstrictor Agents
Analgesics
Cocaine
Analgesics, Opioid
Cocaine-Related Disorders
Heroin Dependence
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Anesthetics, Local
Methamphetamine
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents

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

ClinicalTrials.gov processed this record on May 07, 2009