Combined Treatment for Cocaine-Alcohol Dependence - 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combined Treatment for Cocaine-Alcohol Dependence

Conditions
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Alcohol Dependence, Cocaine Dependence

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Naltrexone | Drug: Naltrexone<br>* Naltrexone<br>* Other names: Naltrexone 100mg/day;|
| Experimental: 2<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Cocaine Dependence