Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 86-93 |
| Number of pages | 8 |
| Journal | Drug and Alcohol Dependence |
| Volume | 98 |
| Issue number | 1-2 |
| DOIs | |
| State | Published - Nov 1 2008 |
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Keywords
- Addiction
- Modafinil
- Nicotine dependence
- Smoking cessation
ASJC Scopus subject areas
- Toxicology
- Pharmacology
- Psychiatry and Mental health
- Pharmacology (medical)
Cite this
A placebo-controlled trial of modafinil for nicotine dependence. / Schnoll, Robert A.; Wileyto, E. Paul; Pinto, Angela; Leone, Frank; Gariti, Peter; Siegel, Steven; Perkins, Kenneth A.; Dackis, Charles; Heitjan, Daniel F.; Berrettini, Wade; Lerman, Caryn.
In: Drug and Alcohol Dependence, Vol. 98, No. 1-2, 01.11.2008, p. 86-93.Research output: Contribution to journal › Article
}
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
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
UR - http://www.scopus.com/inward/record.url?scp=50249164201&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=50249164201&partnerID=8YFLogxK
U2 - 10.1016/j.drugalcdep.2008.04.008
DO - 10.1016/j.drugalcdep.2008.04.008
M3 - Article
C2 - 18541389
AN - SCOPUS:50249164201
VL - 98
SP - 86
EP - 93
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
SN - 0376-8716
IS - 1-2
ER -