Evidence map›Paper›PMID 35470371›Full record

Trial reportAlcohol and alcoholism (Oxford, Oxfordshire)2022

The Effects of Menstrual Cycle Hormones on Responses to Varenicline and Naltrexone Among Female Heavy Drinking Smokers.

ReJoyce Green, Daniel J O Roche, Lara A Ray

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcohol and alcoholism (Oxford, Oxfordshire), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 39% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. 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

3 authors at 2 institutions in 1 country.

ReJoyce GreenDepartment of Psychology, University of California, Los Angeles, CA, USA.ORCID 0000-0003-1892-0289
Daniel J O RocheDepartment of Psychiatry, University of Maryland Baltimore, Baltimore, MD, USA.ORCID 0000-0001-6298-1519
Lara A RayDepartment of Psychology, University of California, Los Angeles, CA, USA.ORCID 0000-0002-5734-9444
University of California, Los Angeles · USUniversity of Maryland, Baltimore · US

Funding

Combining Varenicline and Naltrexone for Smoking Cessation in Heavy DrinkersR01DA041226 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI RAY, LARA A. · 2015 to 2017
$2.1M
Clinical Neuroscience of Alcoholism: Integrating Neuroscience and Clinical TrialsK24AA025704 · NIAAA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LARA A. RAY · 2018 to 2026
$1.3M
Development of minocycline as a neuroimmune therapy for alcohol use disorderK01AA026005 · NIAAA · UNIVERSITY OF MARYLAND BALTIMORE · PI ROCHE, DANIEL · 2017 to 2021
$925k
California Tobacco Related Disease Research Program T30DT0950NIAAA NIH HHS K01 AA026005NIAAA NIH HHS K24AA025704NIDA NIH HHS R01 DA041226NIDA NIH HHS R01DA041226
6 · The paper itself

Abstract

aimsWomen often experience poorer smoking cessation outcomes in comparison to men. Menstrual cycle phase and sex hormones may influence smoking behavior and alter response to opioid antagonist medications. Less is known about the effects of sex hormones in response to pharmacotherapy for female heavy drinking smokers.

methodsThis study is a secondary analysis of premenopausal female heavy drinking smokers who completed a 12-week randomized clinical trial comparing varenicline plus placebo versus varenicline plus naltrexone for smoking cessation and drinking reduction. Participants (n = 26; total observations = 66) provided saliva samples for assays of progesterone (P4) and estradiol (E2) post-randomization at Weeks 4, 8 and 12. We examined the effects of P4/E2 ratio and medication on smoking and drinking outcomes.

resultsFor drinking outcomes, there was a significant interaction for percent days abstinent (b = 0.017, P = 0.05), suggesting that greater P4/E2 ratio is associated with greater percent days abstinent for women assigned to the varenicline plus naltrexone condition. There were no interaction effects for the remaining drinking outcomes (P's ≥ 0.12). Results found no significant interaction effect of P4/E2 ratio and medication on smoking abstinence (P = 0.19).

conclusionOur results imply that when women show a greater P4/E2 ratio, typically observed during the luteal phase of the menstrual cycle, they experience an added benefit of naltrexone, versus placebo, for drinking outcomes as shown by greater percent days abstinent. Additional studies in larger samples are warranted as sex hormones offer important information above and beyond comparing women versus men.

Indexed as

NaltrexoneSmokersDouble-Blind MethodFemaleHormonesHumansMaleMenstrual CycleVareniclineHormonesNaltrexoneVarenicline

Identifiers

PMID35470371
PMCPMC9465527
OpenAlexW4224930861

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.