Evidence map›Paper›PMID 25062287›Full record

Trial reportThe American journal of drug and alcohol abuse2015

An open-label pilot trial of N-acetylcysteine and varenicline in adult cigarette smokers.

Erin A McClure, Nathaniel L Baker, Cassandra D Gipson, Matthew J Carpenter, Amanda P Roper, Brett E Froeliger, Peter W Kalivas, Kevin M Gray

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in The American journal of drug and alcohol abuse, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05903014 (Effectiveness of N-Acetylcysteine in Motivational Enhancement Therapy for Nicotine Addiction), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
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.

NCT05903014 phase4completednot on this mapstarted 2023, after this paper: background citation

Effectiveness of N-Acetylcysteine in Motivational Enhancement Therapy for Nicotine Addiction: Study on the Dopaminergic Pathways, Changes in Functional Connectivity of fMRI Bold, and Changes in Smoking Abstinence

TypeinterventionalSponsorIndonesia UniversityRan2023 to 2023Enrolled90ConditionsNicotine Dependence, Nicotine AddictionArmsn-acetylcysteine, Motivational Enhancement Therapy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Zonisamide Reduces Withdrawal Symptoms But Does Not Enhance Varenicline-Induced Smoking Cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Current psychiatry · 2018
    Article
  17. Review
  18. Glutamate Transport: A New Bench to Bedside Mechanism for Treating Drug Abuse.The international journal of neuropsychopharmacology · 2017
    Review
  19. Article
  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

8 authors at 3 institutions in 3 countries.

Erin A McClureDepartments of Psychiatry and Behavioral Sciences .
Nathaniel L Baker
Cassandra D Gipson
Matthew J Carpenter
Amanda P Roper
Brett E Froeliger
Peter W Kalivas
Kevin M Gray
Institute of Behavioral Sciences · JPMedical University of South Carolina · USFaculty of Public Health · GB

Funding

Selective Restoration of KCNQ Channel Inhibition in the PFC to Inhibit Cue-InducP50DA015369 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ASTON-JONES, GARY S. · 2003 to 2017
$18.6M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
Drug Abuse Research Training (DART) ProgramR25DA020537 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI KATHLEEN T. BRADY, Sudie E Back · 2006 to 2026
$6.3M
A Randomized Controlled Trial of Varenicline for Adolescent Smoking CessationU01DA031779 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI GRAY, KEVIN M · 2012 to 2016
$3.3M
NCATS NIH HHS UL1 TR000062NCATS NIH HHS UL1TR000062NIDA NIH HHS P50 DA015369NIDA NIH HHS P50DA015369NIDA NIH HHS R25 DA020537NIDA NIH HHS U01 DA031779NIDA NIH HHS U01DA031779
6 · The paper itself

Abstract

backgroundVarenicline (VAR) has demonstrated superior efficacy over other smoking cessation pharmacotherapies, though 50-60% of those treated do maintain abstinence. Some preclinical findings suggest that new nicotine dependence pharmacotherapies should target the glutamatergic system, given its demonstrated role in addiction. Attention has been given to N-acetylcysteine (NAC), which appears to restore normal glutamate signaling in animal models. It is possible that NAC and VAR may work in concert to promote abstinence at higher rates than with either medication alone.

objectiveTo demonstrate the feasibility and safety of co-administering NAC and VAR in nicotine-dependent participants.

methodsParticipants (n = 19) were daily cigarette smokers, and did not need to be seeking treatment. They received 4 weeks of open-label treatment with NAC (1200 mg twice daily) and VAR (1 mg twice daily, following titration) and were assessed weekly for adverse events (AEs), smoking, craving and withdrawal.

resultsSixteen participants reported a total of 40 AEs, and most were mild (88%). The most commonly reported AE was nausea (15%). Medication adherence, assessed via self-reports and pill counts, was excellent (98%). Exploratory analyses showed reductions in cigarettes per day, though point prevalence abstinence at the end of the study was low.

conclusionsThese preliminary data provide the first demonstration of safety and feasibility of the co-administration of NAC and VAR in cigarette smokers. AEs were consistent with those typically reported for VAR and NAC. These data support future efficacy research on NAC and VAR for smoking cessation.

Indexed as

AcetylcysteineAdministration, OralAdolescentAdultAgedBenzazepinesDrug Administration ScheduleFemaleHumansMaleMiddle AgedNicotinic AgonistsPilot ProjectsQuinoxalinesSmokingSmoking CessationAcetylcysteineBenzazepinesNicotinic AgonistsQuinoxalinesVareniclineN-acetylcysteinepharmacotherapysafetysmoking cessationtolerabilityvarenicline

Identifiers

PMID25062287
PMCPMC4262740
OpenAlexW2048561835

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.