A placebo-controlled trial of modafinil for nicotine dependence

Robert A. Schnoll, E. Paul Wileyto, Angela Pinto, Frank Leone, Peter Gariti, Steven Siegel, Kenneth A. Perkins, Charles Dackis, Daniel F. Heitjan, Wade Berrettini, Caryn Lerman

Research output: Contribution to journalArticle

29 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)86-93
Number of pages8
JournalDrug and Alcohol Dependence
Volume98
Issue number1-2
DOIs
StatePublished - Nov 1 2008

Fingerprint

Tobacco Use Disorder
Nicotine
Placebos
Smoking
Smoking Cessation
Tobacco Products
Therapeutics
Cocaine-Related Disorders
Substance Withdrawal Syndrome
modafinil
Wakefulness
Cocaine
Fatigue
Psychiatry
Comorbidity
Counseling
Fatigue of materials
Recurrence

Keywords

  • Addiction
  • Modafinil
  • Nicotine dependence
  • Smoking cessation

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

Schnoll, R. A., Wileyto, E. P., Pinto, A., Leone, F., Gariti, P., Siegel, S., ... Lerman, C. (2008). A placebo-controlled trial of modafinil for nicotine dependence. Drug and Alcohol Dependence, 98(1-2), 86-93. https://doi.org/10.1016/j.drugalcdep.2008.04.008

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 journalArticle

Schnoll, RA, Wileyto, EP, Pinto, A, Leone, F, Gariti, P, Siegel, S, Perkins, KA, Dackis, C, Heitjan, DF, Berrettini, W & Lerman, C 2008, 'A placebo-controlled trial of modafinil for nicotine dependence', Drug and Alcohol Dependence, vol. 98, no. 1-2, pp. 86-93. https://doi.org/10.1016/j.drugalcdep.2008.04.008
Schnoll RA, Wileyto EP, Pinto A, Leone F, Gariti P, Siegel S et al. A placebo-controlled trial of modafinil for nicotine dependence. Drug and Alcohol Dependence. 2008 Nov 1;98(1-2):86-93. https://doi.org/10.1016/j.drugalcdep.2008.04.008
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. / A placebo-controlled trial of modafinil for nicotine dependence. In: Drug and Alcohol Dependence. 2008 ; Vol. 98, No. 1-2. pp. 86-93.
@article{193286ab805742d6a65de82201c4e886,
title = "A placebo-controlled trial of modafinil for nicotine dependence",
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.",
keywords = "Addiction, Modafinil, Nicotine dependence, Smoking cessation",
author = "Schnoll, {Robert A.} and Wileyto, {E. Paul} and Angela Pinto and Frank Leone and Peter Gariti and Steven Siegel and Perkins, {Kenneth A.} and Charles Dackis and Heitjan, {Daniel F.} and Wade Berrettini and Caryn Lerman",
year = "2008",
month = "11",
day = "1",
doi = "10.1016/j.drugalcdep.2008.04.008",
language = "English (US)",
volume = "98",
pages = "86--93",
journal = "Drug and Alcohol Dependence",
issn = "0376-8716",
publisher = "Elsevier Ireland Ltd",
number = "1-2",

}

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 -