Safety and tolerability of N-acetylcysteine in cocaine-dependent individuals.
A double-blind placebo-controlled crossover Phase I trial was conducted to assess the safety and tolerability of N-Acetylcysteine (NAC) in healthy, cocaine-dependent humans. Thirteen participants attended a three-day hospitalization in which they received placebo or NAC. Subjects were crossed over to receive the opposite medication condition during a second three-day hospitalization, which occurred the following week. Across placebo and NAC conditions, only mild side effects were noted, and the number of subjects reporting side effects did not differ. There were trends for a greater reduction in withdrawal symptoms and craving within the NAC condition. These preliminary results suggest that NAC is well tolerated in healthy, cocaine-dependent individuals and may reduce cocaine-related withdrawal symptoms and craving.
LaRowe
Steven D
SD
Center for Drug and Alcohol Programs, Medical University of South Carolina, Charleston, South Carolina 29425, USA. larowe@musc.edu
Mardikian
Pascale
P
Malcolm
Robert
R
Myrick
Hugh
H
Kalivas
Peter
P
McFarland
Krista
K
Saladin
Michael
M
McRae
Aimee
A
Brady
Kathleen
K
D000111:Acetylcysteine / Q000009:adverse effects* / Q000627:therapeutic use; D000328:Adult; D003042:Cocaine / Q000009:adverse effects*; D019970:Cocaine-Related Disorders / Q000534:rehabilitation*; D016578:Crack Cocaine / Q000009:adverse effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination / Q000187:drug effects; D016320:Substance Abuse Treatment Centers; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*
D016578:Crack Cocaine; D003042:Cocaine; D000111:Acetylcysteine