A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
Overview
- Phase
- Phase 2
- Intervention
- Naltrexone plus N-Acetyl Cysteine
- Conditions
- Methamphetamine Dependence
- Sponsor
- University of Chicago
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Penn Craving Scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •men and women age 18-65
- •current DSM-IV methamphetamine dependence.
Exclusion Criteria
- •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
Arms & Interventions
Naltrexone plus N-Acetyl Cysteine
Naltrexone tablets N-Acetyl Cysteine: 600mg tablets, daily
Intervention: Naltrexone plus N-Acetyl Cysteine
Placebo
Inactive placebo ("sugar pill")
Intervention: Placebo
Outcomes
Primary Outcomes
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.