Evidence map›Paper›PMID 26476459›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2016

Zonisamide Reduces Withdrawal Symptoms But Does Not Enhance Varenicline-Induced Smoking Cessation.

Kelly E Dunn, Taylor F Marcus, Cynthia Kim, Jennifer R Schroeder, Ryan Vandrey, Annie Umbricht

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 33% 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

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
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  4. Article
  5. 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

6 authors at 3 institutions in 1 country.

Kelly E DunnDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD;
Taylor F MarcusDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD;
Cynthia KimDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD;
Jennifer R SchroederSchroeder Statistical Consulting, Ellicott City, MD.
Ryan VandreyDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD;
Annie UmbrichtDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD; annieumbricht@jhu.edu.
Johns Hopkins University · USJohns Hopkins Medicine · USStatistical Research (United States) · US

Funding

A118G SNP and OPRM1 Gene Opioid-Mediated Effects in HumansR01DA035246 · NIDA · JOHNS HOPKINS UNIVERSITY · PI DUNN, KELLY E · 2014 to 2018
$3.2M
Development and Validation of a Computerized Opioid Overdose InterventionR21DA035327 · NIDA · JOHNS HOPKINS UNIVERSITY · PI DUNN, KELLY E · 2013 to 2014
$446k
Zonisamide Augmentation of Varenicline for Smoking CessationR21DA034164 · NIDA · JOHNS HOPKINS UNIVERSITY · PI UMBRICHT, ANNIE · 2012 to 2013
$424k
NIDA NIH HHS DA034164NIDA NIH HHS R01 DA035246NIDA NIH HHS R21 DA034164NIDA NIH HHS R21 DA035327
6 · The paper itself

Abstract

introductionVarenicline (Chantix) is a first-line treatment for smoking cessation but does not produce cessation in many individuals. It may be possible to improve abstinence by co-administering varenicline with other medications. Zonisamide (Zonegran) has a similar pharmacologic profile to topiramate, which has been shown to reduce smoking, but is better tolerated. This study evaluated whether combined zonisamide and varenicline reduced tobacco withdrawal and increased abstinence among smokers trying to quit, relative to varenicline and placebo.

methodsThis was a double-blind, randomized, placebo-controlled pilot trial of zonisamide + varenicline versus placebo + varenicline for smoking cessation. Smokers received brief counseling and study medications, and completed weekly assessments for 10 consecutive weeks. The primary outcome was continuous abstinence rates (biochemically verified) during the final 4 weeks of treatment.

resultsResults are presented as intent-to-treat and completer analyses. Seventy-four individuals were enrolled; 45 completed the study. Overall, 14.9% (intent-to-treat) and 25.0% (completer) of participants maintained sustained abstinence during the final 4 weeks of treatment. There were no differences between groups for biochemically-verified smoking, but zonisamide + varenicline reduced self-reported smoking, nicotine withdrawal, and craving compared to placebo + varenicline.

conclusionsZonisamide decreased nicotine withdrawal and craving, though not of sufficient magnitude to modify smoking behavior. The sample size was small and low rates of abstinence across groups suggest the study population was difficult to treat. Additional evaluation of zonisamide or other medications that increase GABA or decrease glutamate in larger or more diverse populations may yield positive clinical benefit for nicotine/tobacco cessation. IMPLICATIONS: This study provides support for layering novel medications with varenicline for smoking cessation, for investigating medications that target the GABA and glutamate system, and for assessing the contribution that reductions in nicotine withdrawal have on ultimate cessation outcomes.

Indexed as

AdultHumansIsoxazolesNicotinic AgonistsSmoking CessationSubstance Withdrawal SyndromeVareniclineZonisamideIsoxazolesNicotinic AgonistsVareniclineZonisamide

Identifiers

PMID26476459
PMCPMC5942620
OpenAlexW2325140881

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.