N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Naltrexone plus N-Acetyl Cysteine

Naltrexone tablets

N-Acetyl Cysteine: 600mg tablets, daily

Group Type EXPERIMENTAL

Naltrexone plus N-Acetyl Cysteine

Intervention Type DRUG

daily

Placebo

Inactive placebo ("sugar pill")

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

daily

Interventions

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Naltrexone plus N-Acetyl Cysteine

daily

Intervention Type DRUG

Placebo

daily

Intervention Type DRUG

Other Intervention Names

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Naltrexone: Revia

Eligibility Criteria

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Inclusion Criteria

1. men and women age 18-65
2. current DSM-IV methamphetamine dependence.

Exclusion Criteria

1. unstable medical illness
2. history of seizures
3. myocardial infarction within 6 months
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
5. any thoughts of suicide
6. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
7. previous treatment with N-Acetyl Cysteine or naltrexone
8. 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
9. abnormal liver function tests at screening
10. diagnosis of asthma
11. current use of opiates.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No