N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

University of Chicago45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Methamphetamine Dependence

Interventions

Naltrexone plus N-Acetyl CysteineDRUG

daily

PlaceboDRUG

daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: beginning and at each visit until the end of their participation in the study

Data from ClinicalTrials.gov

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