TY - JOUR
T1 - A placebo-controlled trial of modafinil for nicotine dependence
AU - Schnoll, Robert A.
AU - Wileyto, E. Paul
AU - Pinto, Angela
AU - Leone, Frank
AU - Gariti, Peter
AU - Siegel, Steven
AU - Perkins, Kenneth A.
AU - Dackis, Charles
AU - Heitjan, Daniel F.
AU - Berrettini, Wade
AU - Lerman, Caryn
N1 - Funding Information:
Role of funding source: This research was supported by Commonwealth of Pennsylvania Department of Health grant SAP #4100027297 (R.A.S., C.L.) and a Transdisciplinary Tobacco Use Research Center Grant from the National Cancer Institute and the National Institute on Drug Abuse P5084718 (C.L.). In addition, Cephalon, the company that manufactures modafinil provided the study medication and financial support for follow-up interviews for this study.
PY - 2008/11/1
Y1 - 2008/11/1
N2 - Background: Nicotine deprivation symptoms, including fatigue and attentional deficits, predict relapse following smoking cessation. Modafinil (Provigil), a wakefulness medication shown to have efficacy for the treatment of cocaine addiction, was tested as a novel therapy for nicotine dependence in a double-blind placebo-controlled trial. Methods: One hundred and fifty-seven treatment-seeking smokers received brief smoking cessation counseling and were randomized to: (1) 8 weeks of modafinil (200 mg/day), or (2) 8 weeks of placebo. The primary outcome was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT). Secondary outcomes included cigarette smoking rate and post-quit nicotine deprivation symptoms (e.g., negative affect, withdrawal). Results: In this interim study analysis, EOT quit rates did not differ between treatment arms (42% for placebo vs. 34% for modafinil; OR = 0.67 [0.34-1.31], p = 0.24). Further, from the target quit date to EOT, the daily smoking rate was 44% higher among non-abstainers in the modafinil arm, compared to non-abstainers in the placebo arm (IRR = 1.44, CI95 = 1.09-1.89, p < 0.01). Modafinil-treated participants also reported greater increases in negative affect and withdrawal symptoms, vs. participants randomized to placebo (ps < 0.05). Conclusions: These data do not support the use of modafinil for the treatment of nicotine dependence and, as a consequence, this trial was discontinued. Cigarette smoking should be considered when modafinil is prescribed, particularly among those with psychiatric conditions that have high comorbidity with nicotine dependence.
AB - Background: Nicotine deprivation symptoms, including fatigue and attentional deficits, predict relapse following smoking cessation. Modafinil (Provigil), a wakefulness medication shown to have efficacy for the treatment of cocaine addiction, was tested as a novel therapy for nicotine dependence in a double-blind placebo-controlled trial. Methods: One hundred and fifty-seven treatment-seeking smokers received brief smoking cessation counseling and were randomized to: (1) 8 weeks of modafinil (200 mg/day), or (2) 8 weeks of placebo. The primary outcome was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT). Secondary outcomes included cigarette smoking rate and post-quit nicotine deprivation symptoms (e.g., negative affect, withdrawal). Results: In this interim study analysis, EOT quit rates did not differ between treatment arms (42% for placebo vs. 34% for modafinil; OR = 0.67 [0.34-1.31], p = 0.24). Further, from the target quit date to EOT, the daily smoking rate was 44% higher among non-abstainers in the modafinil arm, compared to non-abstainers in the placebo arm (IRR = 1.44, CI95 = 1.09-1.89, p < 0.01). Modafinil-treated participants also reported greater increases in negative affect and withdrawal symptoms, vs. participants randomized to placebo (ps < 0.05). Conclusions: These data do not support the use of modafinil for the treatment of nicotine dependence and, as a consequence, this trial was discontinued. Cigarette smoking should be considered when modafinil is prescribed, particularly among those with psychiatric conditions that have high comorbidity with nicotine dependence.
KW - Addiction
KW - Modafinil
KW - Nicotine dependence
KW - Smoking cessation
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U2 - 10.1016/j.drugalcdep.2008.04.008
DO - 10.1016/j.drugalcdep.2008.04.008
M3 - Article
C2 - 18541389
AN - SCOPUS:50249164201
SN - 0376-8716
VL - 98
SP - 86
EP - 93
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
IS - 1-2
ER -