Evidence map›Paper›PMID 18541389›Full record

Trial reportDrug and alcohol dependence2008

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 and 1 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Initial Evaluation of Fenofibrate for Efficacy in Aiding Smoking Abstinence.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Trial
  3. Trial
  4. A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014
    Trial
  5. Trial
  6. Trial
  7. The 2022 Ferno Award Address: CrEATE, an Efficient Crossover Evaluation of Addiction Treatment Efficacy.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023
    Article
  8. Review
  9. The Role of Cognitive Control in the Self-Regulation and Reinforcement of Smoking Behavior.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Review
  10. Initial Cross-Over Test of A Positive Allosteric Modulator of Alpha-7 Nicotinic Receptors to Aid Cessation in Smokers With Or Without Schizophrenia.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2018
    Article
  11. Review
  12. Review
  13. R-modafinil attenuates nicotine-taking and nicotine-seeking behavior in alcohol-preferring rats.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2015
    Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Robert A SchnollDepartment of Psychiatry, Abramson Cancer Center, and Annenberg Public Policy Center, University of Pennsylvania, Philadelphia, PA, United States. schnoll@mail.med.upenn.edu
E Paul Wileyto
Angela Pinto
Frank Leone
Peter Gariti
Steven Siegel
Kenneth A Perkins
Charles Dackis
Daniel F Heitjan
Wade Berrettini
Caryn Lerman
University of Pennsylvania · USUniversity of Pittsburgh · US

Funding

TRANSDISCIPLINARY TOBACCO USE RESEARCH CENTERSP50CA084718 · NCI · UNIVERSITY OF PENNSYLVANIA · PI LERMAN, CARYN · 1999 to 2008
$17.8M
NCI NIH HHS P50 CA084718PHS HHS P5084718
6 · The paper itself

Abstract

backgroundNicotine 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.

methodsOne hundred and fifty-seven treatment-seeking smokers received brief smoking cessation counseling and were randomized to: (1) 8 weeks of modafinil (200mg/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).

resultsIn 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).

conclusionsThese 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.

Indexed as

AdultBenzhydryl CompoundsCentral Nervous System StimulantsDouble-Blind MethodFemaleHumansMaleMiddle AgedModafinilNicotineSmoking CessationSubstance Withdrawal SyndromeTobacco Use DisorderBenzhydryl CompoundsCentral Nervous System StimulantsModafinilNicotine

Identifiers

PMID18541389
PMCPMC2610628
OpenAlexW2072362899

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.