NCT00218491

Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1

A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized by the body to form cysteine, an active compound that normalizes glutamate levels. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals.

Detailed description

Currently, no effective pharmacological treatment exists for cocaine dependence. Long-term use of cocaine disrupts normal glutamate levels. If addicts stop using cocaine, glutamate levels drop, which encourages addicts to continue seeking the drug. NAC is a drug that increases intracellular cysteine levels, which in turn leads to normalization of glutamate levels. Currently, NAC is used for the treatment of cystic fibrosis, heart disease, and acetaminophen overdose. Since NAC has the capability of restoring normal glutamate levels, it holds potential as a treatment for cocaine dependence. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals. In addition, this study will evaluate cocaine craving and withdrawal symptoms in individuals taking NAC. Participants in this double-blind, placebo-controlled trial will be randomly assigned to receive either NAC or placebo. All participants will undergo an initial evaluation, which will include a physical examination, an electrocardiogram, blood samples, urine tests, and cue reactivity measures. Participants in the NAC group will receive either 600 mg or 1200 mg of NAC, two times each day for 8 weeks. In addition, all participants will receive cognitive behavioral therapy throughout the study on a weekly basis. Cocaine use will be confirmed by a urine drug screen test, three times each week. Participants will be assessed on a number of biomedical and psychosocial variables known to influence cocaine treatment outcomes. After Week 2, participants will repeat the cue reactivity procedures, which will include measuring a participant's craving response when exposed to conditioned reminders of prior cocaine use.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	N-Acetylcysteine	1200mg N-Acetylcysteine
DRUG	N-Acetylcysteine	2400mg N-Acetylcysteine
DRUG	Matching Placebo	Matching Placebo

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2005-09-22
• Last updated: 2019-01-15
• Results posted: 2019-01-15

Locations

1 site across 1 country: United States