TY - JOUR
T1 - The safety of disulfiram for the treatment of alcohol and cocaine dependence in randomized clinical trials
T2 - Guidance for clinical practice
AU - Malcolm, Robert
AU - Olive, M. Foster
AU - Lechner, William
PY - 2008/7
Y1 - 2008/7
N2 - Background: Disulfiram has demonstrated efficacy in six randomized clinical trials for the treatment of cocaine dependence, but is rarely used in clinical settings because of safety concerns. Objective: What are the common and serious side effects of disulfiram in cocaine-dependent individuals with and without alcohol dependence in randomized clinical trials? Methods: We located Phase I and II randomized trials that discussed the safety of disulfiram. Results/conclusions: In randomized clinical trials that eliminated subjects with serious cardiovascular, hepatic, and psychiatric disorders, the most frequent side effects of disulfiram over placebo or index groups include headaches, fatigue, sleepiness, and anxiety. Disulfiram in a dose of ≤ 250 mg/day led to only mild interactions with alcohol. When patients are screened for medical and psychiatric stability, and are evaluated for drug interactions, disulfiram has an acceptable side-effect profile for the treatment of cocaine dependence with or without alcohol dependence.
AB - Background: Disulfiram has demonstrated efficacy in six randomized clinical trials for the treatment of cocaine dependence, but is rarely used in clinical settings because of safety concerns. Objective: What are the common and serious side effects of disulfiram in cocaine-dependent individuals with and without alcohol dependence in randomized clinical trials? Methods: We located Phase I and II randomized trials that discussed the safety of disulfiram. Results/conclusions: In randomized clinical trials that eliminated subjects with serious cardiovascular, hepatic, and psychiatric disorders, the most frequent side effects of disulfiram over placebo or index groups include headaches, fatigue, sleepiness, and anxiety. Disulfiram in a dose of ≤ 250 mg/day led to only mild interactions with alcohol. When patients are screened for medical and psychiatric stability, and are evaluated for drug interactions, disulfiram has an acceptable side-effect profile for the treatment of cocaine dependence with or without alcohol dependence.
KW - Alcohol dependence
KW - Cocaine dependence
KW - Disulfiram
KW - RCTs
KW - Randomized clinical trials
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=48749097099&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=48749097099&partnerID=8YFLogxK
U2 - 10.1517/14740338.7.4.459
DO - 10.1517/14740338.7.4.459
M3 - Review article
C2 - 18613809
AN - SCOPUS:48749097099
SN - 1474-0338
VL - 7
SP - 459
EP - 472
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
IS - 4
ER -