Phase 2 N=45 Randomized Double-blind Treatment

N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence

Methamphetamine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00332605 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Penn Craving Scale — 24.0; 24.0; 21.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naltrexone plus N-Acetyl Cysteine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Penn Craving Scale	24.0; 24.0; 21.1	—

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.

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
current use of opiates.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00332605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.