N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Methamphetamine Dependence Clinical Trial

Official title:

A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332605
• Other study ID #: 0601M80486
• Status: Completed
• Phase: Phase 2
• Start date: June 2006
• Est. completion date: January 2010

Study information

• Verified date: July 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Drug:
• Naltrexone plus N-Acetyl Cysteine
daily
• Placebo
daily

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penn Craving Scale	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.	beginning and at each visit until the end of their participation in the study