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N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332605
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : July 24, 2013
Last Update Posted : November 30, 2017
Information provided by (Responsible Party):
Jon Grant, University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Naltrexone plus N-Acetyl Cysteine Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
Study Start Date : June 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: Naltrexone plus N-Acetyl Cysteine

Naltrexone tablets

N-Acetyl Cysteine: 600mg tablets, daily

Drug: Naltrexone plus N-Acetyl Cysteine
Other Names:
  • Naltrexone:
  • Revia

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332605

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Jon E Grant, MD, JD University of Chicago
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Responsible Party: Jon Grant, Professor of Psychiatry, University of Minnesota Identifier: NCT00332605    
Other Study ID Numbers: 0601M80486
First Posted: June 1, 2006    Key Record Dates
Results First Posted: July 24, 2013
Last Update Posted: November 30, 2017
Last Verified: October 2017
Keywords provided by Jon Grant, University of Minnesota:
Methamphetamine Dependence
Additional relevant MeSH terms:
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Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents