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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

Page last updated: August 23, 2015

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