N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00332605
First received: May 30, 2006
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Methamphetamine Dependence
Drug: Naltrexone plus N-Acetyl Cysteine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Penn Craving Scale [ Time Frame: beginning and at each visit until the end of their participation in the study ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: June 2006
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone plus N-Acetyl Cysteine

Naltrexone tablets

N-Acetyl Cysteine: 600mg tablets, daily

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332605

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, MD, JD University of Chicago
  More Information

No publications provided

Responsible Party: Jon Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00332605     History of Changes
Other Study ID Numbers: 0601M80486
Study First Received: May 30, 2006
Results First Received: March 1, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Methamphetamine Dependence

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Naltrexone
Methamphetamine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014