Combined Treatment for Cocaine-Alcohol Dependence - 1

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Cocaine Dependence

Alcohol Dependence

Treatments

Drug: Placebo

Drug: Naltrexone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00218569

R01DA015801 (U.S. NIH Grant/Contract)

R01-15801-1

NIDA-15801-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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