N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Phase 2

Completed

• Conditions: Methamphetamine Dependence
• Interventions: Drug: Naltrexone plus N-Acetyl Cysteine; Drug: Placebo

• Registration Number: NCT00332605
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study Start: 2006-06
• Study First Posted: 2006-06-01
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Results First Submitted: 2012-03-01
• Results First Submitted QC: 2013-06-18
• Results First Posted: 2013-07-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone plus N-Acetyl Cysteine	Naltrexone plus N-Acetyl Cysteine	Naltrexone tablets N-Acetyl Cysteine: 600mg tablets, daily
Placebo	Placebo	Inactive placebo ("sugar pill")

Primary Outcome Measures

Name	Time	Method
Penn Craving Scale	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States