Status:
COMPLETED
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
Lead Sponsor:
University of Chicago
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 naltrex...
Eligibility Criteria
Inclusion
- men and women age 18-65
- current DSM-IV methamphetamine dependence.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00332605
Start Date
June 1 2006
End Date
January 1 2010
Last Update
August 23 2022
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637