Combined Treatment for Cocaine-Alcohol Dependence - 1

NCT ID: NCT00218569

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Alcohol Dependence; Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Naltrexone

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Naltrexone

2

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo

Interventions

Naltrexone

Naltrexone

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Naltrexone 100mg/day

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Joy Schmitz

Professor - Psy, Behavioral Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joy Schmitz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Health Sci Cntr Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

R01DA015801

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-15801-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-15801-1

Identifier Type: -

Identifier Source: org_study_id