CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
N-Acetylcysteine +2 moredrug
Likely dose
N-Acetylcysteine 1200 mg or 2400 mg dailyAI-extracted
Key inclusion· 6
  • ✓Meets DSM-IV criteria for cocaine dependence, as determined by a mini-SCID interview
  • ✓Currently dependent on cocaine
  • ✓Seeking treatment for cocaine abuse at the time of study entry
  • ✓Currently uses cocaine by smoking, nasal, or intravenous route of administration
Key exclusion· 10
  • ✕Dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana
  • ✕Physiological dependence on alcohol requiring medical detoxification
  • ✕History of significant liver, kidney, cardiac, stroke, seizure, or other major organ system disorders
  • ✕History of adverse reaction to cocaine (loss of consciousness, chest pain, psychosis, or seizure)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00218491
NCT00218491Phase 2Completed
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A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence

Medical University of South Carolina·interventional·Posted Sep 22, 2005·Updated Jan 15, 2019

In Brief

A Phase 2 clinical trial evaluating N-Acetylcysteine and Matching Placebo for Cocaine Dependence. Completed, enrolled 111 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartNov 1, 2005
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.8 years ago

Interventions

N-Acetylcysteinedrug

1200mg N-Acetylcysteine

N-Acetylcysteinedrug

2400mg N-Acetylcysteine

Matching Placebodrug

Matching Placebo