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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.
 
ClinicalTrials.gov Identifier: NCT00332605
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : July 24, 2013
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Minnesota

Tracking Information
First Submitted Date  ICMJE May 30, 2006
First Posted Date  ICMJE June 1, 2006
Results First Submitted Date  ICMJE March 1, 2012
Results First Posted Date  ICMJE July 24, 2013
Last Update Posted Date November 30, 2017
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2006)
Penn Craving Scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2006)
Urine toxicology screens
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
Official Title  ICMJE A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Methamphetamine Dependence
Intervention  ICMJE
  • Drug: Naltrexone plus N-Acetyl Cysteine
    daily
    Other Names:
    • Naltrexone:
    • Revia
  • Drug: Placebo
    daily
Study Arms  ICMJE
  • Experimental: Naltrexone plus N-Acetyl Cysteine

    Naltrexone tablets

    N-Acetyl Cysteine: 600mg tablets, daily

    Intervention: Drug: Naltrexone plus N-Acetyl Cysteine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2013)
45
Original Enrollment  ICMJE
 (submitted: May 30, 2006)
40
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332605
Other Study ID Numbers  ICMJE 0601M80486
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jon Grant, University of Minnesota
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jon E Grant, MD, JD University of Chicago
PRS Account University of Chicago
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP