Combined Treatment for Cocaine-Alcohol Dependence - 1

Combined Treatment for Cocaine-Alcohol Dependence

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence; Cocaine Dependence
• Intervention / Treatment: Drug: Placebo; Drug: Naltrexone

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
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Sci Cntr Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; Placebo	Drug: Placebo; Placebo
Experimental: 1; Naltrexone	Drug: Naltrexone; Naltrexone; Other Names: Naltrexone 100mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urine toxicology for cocaine	12 weeks of study

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Alcohol Dependence; Cocaine Dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Cocaine-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: NIDA-15801-1; R01DA015801 (U.S. NIH Grant/Contract); R01-15801-1