N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methamphetamine Dependence
Intervention: Naltrexone plus N-Acetyl Cysteine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Jon E Grant, MD, JD, Principal Investigator, Affiliation: University of Chicago
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.
Clinical Details
Official title: A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Penn Craving Scale
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Starting date: June 2006
Last updated: July 7, 2014
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