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Combined Treatment for Cocaine-Alcohol Dependence - 1

This study has been completed.
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218569
First received: September 20, 2005
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.


Condition Intervention Phase
Alcohol Dependence
Cocaine Dependence
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Treatment for Cocaine-Alcohol Dependence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Urine toxicology for cocaine [ Time Frame: 12 weeks of study ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: April 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Naltrexone
Drug: Naltrexone
Naltrexone
Other Name: Naltrexone 100mg/day
Experimental: 2
Placebo
Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence. Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP). Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits. Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions. CMP will be based on cocaine-negative urine screens and negative breath alcohol tests. Follow-up assessments will be conducted at 3 and 6 months after treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Give informed consent
  • Be able to understand the nature of the study, agree to comply with study requirements, report regularly for scheduled visits, and communicate with study personnel about adverse events and concomitant medication use
  • Be between 18 and 60 years old
  • Meet DSM-IV criteria for both current cocaine and alcohol dependence
  • Be in acceptable health based on physical exam, lab tests, and EKG
  • Have a stable living situation and the availability of at least two locators
  • Be able to read and write English at the 6th grade level
  • Provide a least one cocaine positive urine during intake
  • If female, must agree to use contraception

Exclusion Criteria:

  • History of evidence of a medical condition that would expose them to an undue risk or interfere with assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, or neurologic disease as determined by the clinical judgment of the research team
  • Medical condition that is contraindicated with opioid antagonists or necessitates opiate medication
  • Abnormal liver function test results (both ALT and AST >3x upper limit normal or either >5x upper limit normal)
  • Currently in treatment or have received treatment in the past six months for substance abuse or another psychiatric condition
  • Evidence of a Axis I disorder that will interfere with the course of the trial, including but not limited to current Major Depressive Disorder, Bipolar Disorder, Panic Disorder, Schizophrenia, Bulimia nervosa or Anorexia, and Post-traumatic stress disorder as determined by the clinical judgment of the research team
  • Participating in 12 step meetings more than twice weekly
  • Opiate abuse or dependence in the last five years or used opiates, barbiturates, benzodiazepines in the last thirty days
  • Current dependence on any psychoactive disorder other than nicotine
  • Impending incarceration
  • Condition of probation or parole requiring reports of drug use to officers of the court
  • Women of child bearing potential must not be pregnant/lactating or unwilling to use an acceptable contraceptive method
  • Plans to move from the Houston area within the next three months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218569

Locations
United States, Texas
University of Texas Health Sci Cntr Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Joy Schmitz, Ph.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Joy M. Schmitz, Ph.D., University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00218569     History of Changes
Other Study ID Numbers: NIDA-15801-1, R01-15801-1
Study First Received: September 20, 2005
Last Updated: August 14, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Naltrexone
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014