Evidence map›Paper›PMID 29912798›Full record

Trial reportJournal of clinical psychopharmacology2018

Phase IIb Trial of an α7 Nicotinic Receptor Partial Agonist With and Without Nicotine Patch for Withdrawal-Associated Cognitive Deficits and Tobacco Abstinence.

Randi Melissa Schuster, Gladys N Pachas, Luke Stoeckel, Corinne Cather, Mireya Nadal, David Mischoulon, David A Schoenfeld, Haiyue Zhang, Christine Ulysse, Elisabeth B Dodds and 5 more

Open access · greenAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 37% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

15 authors at 2 institutions in 1 country.

Randi Melissa Schuster
Gladys N Pachas
Luke Stoeckel
Corinne Cather
Mireya Nadal
David Mischoulon
David A Schoenfeld
Haiyue ZhangDepartment of Biostatistics, Massachusetts General Hospital, Boston, MA.
Christine UlysseDepartment of Biostatistics, Massachusetts General Hospital, Boston, MA.
Elisabeth B Dodds
Sara Sobolewski
Vicenta Hudziak
Ailish Hanly
Maurizio Fava
A Eden Evins
Massachusetts General Hospital · USHarvard University · US

Funding

Proof-of-Concept Trial of an Alpha-7 Nicotinic Agonist for Nicotine DependenceR01DA030992 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI EVINS, A EDEN, FAVA, MAURIZIO · 2011 to 2015
$5.9M
Mentoring in Addiction Treatment ResearchK24DA030443 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI EVINS, A EDEN · 2010 to 2020
$2.0M
Cognitive Recovery With Cannabis Abstinence Among High School-Aged AdolescentsK23DA042946 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI SCHUSTER, RANDI MELISSA · 2017 to 2021
$1.1M
NIDA NIH HHS K23 DA042946NIDA NIH HHS K24 DA030443NIDA NIH HHS R01 DA030992
6 · The paper itself

Abstract

PURPOSE/

backgroundThe objective of this study was to determine whether a novel α7 nicotinic acetylcholine receptor partial agonist improves cognition during nicotine withdrawal and improves abstinence rates. To do so, the effect of the α7 nicotinic acetylcholine receptor partial agonist, encenicline, on cognition and abstinence was evaluated when given as monotherapy and when combined with transdermal nicotine patch (nicotine replacement therapy [NRT]).

methodsAdult daily smokers, n = 160, who were motivated to quit smoking completed cognitive testing at satiated baseline and after overnight abstinence and then were randomized to receive a 12-week trial of encenicline 1 mg twice daily or identical placebo the day of the overnight abstinent cognitive testing. In the first 6 weeks of the 12-week encenicline administration, participants were also randomized to 6 weeks of NRT patch or placebo patch. Primary outcomes were cognition during abstinence and 7-day point-prevalence abstinence at week 12.

resultsNo beneficial effects of encenicline were observed on cognition or abstinence when compared with placebo or when combined with NRT compared with placebo capsule + NRT. Of the 4 conditions, abstinence rates were lowest among those assigned to encenicline alone.

conclusionsBeneficial effects of NRT were observed on cognitive and abstinence outcomes when combined with encenicline compared with encenicline plus placebo patch. Addition of NRT to encenicline improved odds of abstinence approximately 3-fold compared with encenicline plus placebo patch. We conclude that encenicline, 1 mg/d, did not improve abstinence-associated cognitive impairment or abstinence rates as monotherapy or adjunctive therapy to NRT patch.

Indexed as

Tobacco Use Cessation DevicesAdultalpha7 Nicotinic Acetylcholine ReceptorCognitive DysfunctionDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleNicotineNicotinic AgonistsSubstance Withdrawal SyndromeTobacco Use Cessationalpha7 Nicotinic Acetylcholine ReceptorNicotineNicotinic Agonists

Identifiers

PMID29912798
PMCPMC6019566
OpenAlexW2808009711

What OpenQuestion holds

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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.