N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Study Overview
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Brief Summary
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The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in combination with naltrexone in methamphetamine dependence.

Detailed Description
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Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine dependence compared to placebo. The proposed study will provide needed data on the treatment of a public health crisis that currently lacks a clearly effective treatment.

Official Title
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A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Drug: Naltrexone plus N-Acetyl Cysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 18-65 current DSM-IV methamphetamine dependence. Exclusion Criteria: unstable medical illness history of seizures myocardial infarction within 6 months current pregnancy or lactation, or inadequate contraception in women of childbearing potential any thoughts of suicide lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder previous treatment with N-Acetyl Cysteine or naltrexone treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline abnormal liver function tests at screening diagnosis of asthma current use of opiates.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone plus N-Acetyl Cysteine<br>Naltrexone tablets N-Acetyl Cysteine: 600mg tablets, daily | Drug: Naltrexone plus N-Acetyl Cysteine<br>* daily<br>* Other names: Revia;|
| Placebo Comparator: Placebo<br>Inactive placebo (sugar pill) | Drug: Placebo<br>* daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn Craving Scale | used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome. | beginning and at each visit until the end of their participation in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methamphetamine Dependence