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Completed

NCT Number: NCT00332605

N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

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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Key information

Conditions

Methamphetamine Dependence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone plus N-Acetyl Cysteine

Drug

daily

Other names: Naltrexone:, Revia

Placebo

Drug

daily

Primary outcomes

  1. Penn Craving Scale

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

    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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jun 1, 2006
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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