Evidence map›Paper›PMID 20542391›Full record

Trial reportDrug and alcohol dependence2010

Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial.

Benjamin A Toll, Marney White, Ran Wu, Boris Meandzija, Peter Jatlow, Robert Makuch, Stephanie S O'Malley

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00105482 (Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain), which is not on this map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
2.7field-weighted citation impact, top 11% 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.

NCT00105482 phase2completednot on this map

Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain

TypeinterventionalSponsorYale UniversityRan2005 to 2009Enrolled172ConditionsNicotine DependenceArmsNaltrexone, Transdermal nicotine replacement, Behavioral counseling
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Interventions for preventing weight gain after smoking cessation.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Pooled it
  3. Opioid antagonists for smoking cessation.The Cochrane database of systematic reviews · 2013
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Menthol cigarette use predicts treatment outcomes of weight-concerned smokers.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Review
  15. Review
  16. Article
  17. The opioid receptors as targets for drug abuse medication.British journal of pharmacology · 2015
    Review
  18. Article
  19. Article
  20. Article
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

7 authors at 2 institutions in 1 country.

Benjamin A TollYale University School of Medicine, New Haven, CT 06519, USA; Yale Cancer Center, New Haven, CT 06519, USA.
Marney White
Ran Wu
Boris Meandzija
Peter Jatlow
Robert Makuch
Stephanie S O'Malley
Yale University · USYale Cancer Center · US

Funding

SUBSTANCE ABUSEK12DA000167 · NIDA · YALE UNIVERSITY · PI STEPHANIE S O'MALLEY, Marc N Potenza · 1991 to 2026
$17.7M
Tobacco Dependence &Risk Factors for Treatment FailureP50AA015632 · NIAAA · YALE UNIVERSITY · PI O'MALLEY, STEPHANIE S · 2004 to 2008
$9.2M
Improving Alcoholism TreatmentK05AA014715 · NIAAA · YALE UNIVERSITY · PI O'MALLEY, STEPHANIE S · 2004 to 2013
$2.1M
Craving, Binge Eating, and ObesityK23DK071646 · NIDDK · YALE UNIVERSITY · PI WHITE, MARNEY A · 2005 to 2009
$673k
NIAAA NIH HHS K05 AA014715NIAAA NIH HHS K05-AA014715NIAAA NIH HHS P50 AA015632NIAAA NIH HHS P50-AA15632NIDA NIH HHS K12 DA000167NIDA NIH HHS K12-DA000167NIDDK NIH HHS K23 DK071646
6 · The paper itself

Abstract

backgroundFear of weight gain is a significant obstacle to smoking cessation, preventing some smokers from attempting to quit. Several previous studies of naltrexone yielded promising results for minimization of post-quit weight gain. Given these encouraging findings, we endeavored to test whether minimization of weight gain might translate to better quit outcomes for a population that is particularly concerned about gaining weight upon quitting.

methodsSmokers (N=172) in this investigation were prospectively randomized to receive either 25 mg naltrexone or placebo for 27 weeks (1 week pre-, 26 weeks post-quit) for minimization of post-quit weight gain and smoking cessation. All participants received open label therapy with the nicotine patch for the first 8 weeks post-quit and behavioral counseling over the 27-week treatment. The 2 pre-specified primary outcomes were change in weight for continuously abstinent participants and biologically verified end-of-treatment 7-day point-prevalence abstinence at 26 weeks after the quit date.

resultsThe difference in weight at 26 weeks post-quit between the naltrexone and placebo groups (naltrexone: 6.8 lbs ± 8.94 vs placebo: 9.7 lbs ± 9.19, p = 0.45) was not statistically different. Seven-day point-prevalence smoking abstinence rates at 26 weeks post-quit was not significantly different between the 2 groups (naltrexone: 22% vs placebo: 27%, p = 0.43).

conclusionsFor smokers high in weight concern, the relatively small reduction in weight gain with low-dose naltrexone is not worth the potential for somewhat lower rates of smoking abstinence.

Indexed as

Administration, CutaneousAdultDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNaltrexoneNicotineProspective StudiesSmokingSmoking CessationWeight GainNaltrexoneNicotine

Identifiers

PMID20542391
PMCPMC3771701
OpenAlexW2005162573

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.