Combined Treatment for Cocaine-Alcohol Dependence - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218569
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 27, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston

Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Dependence Cocaine Dependence Drug: Naltrexone Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Treatment for Cocaine-Alcohol Dependence
Study Start Date : April 2003
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Naltrexone
Other Name: Naltrexone 100mg/day
Experimental: 2
Drug: Placebo

Primary Outcome Measures :
  1. Urine toxicology for cocaine [ Time Frame: 12 weeks of study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218569

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
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joy Schmitz, Ph.D. The University of Texas Health Science Center, Houston

Responsible Party: Joy Schmitz, Professor - Psy, Behavioral Science, The University of Texas Health Science Center, Houston Identifier: NCT00218569     History of Changes
Other Study ID Numbers: NIDA-15801-1
R01DA015801 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by Joy Schmitz, The University of Texas Health Science Center, Houston:
Alcohol Dependence
Cocaine Dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents