Evidence map›Paper›PMID 27159341›Full record

Trial reportJournal of addiction medicine

Effect of Lowering the Dose of Varenicline on Alcohol Self-administration in Drinkers With Alcohol Use Disorders.

Terril L Verplaetse, Brian P Pittman, Julia M Shi, Jeanette M Tetrault, Sabrina Coppola, Sherry A McKee

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Efficacy of Varenicline in the Treatment of Alcohol Dependence: An Updated Meta-Analysis and Meta-Regression.International journal of environmental research and public health · 2023
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Promoting activity of (α4)Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2020
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. 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

6 authors.

Terril L VerplaetseDepartment of Psychiatry (TLV, BPP, SC, SAM); and Department of Internal Medicine (JMS, JMT), Yale University School of Medicine, New Haven, CT.
Brian P Pittman
Julia M Shi
Jeanette M Tetrault
Sabrina Coppola
Sherry A McKee

Funding

Research Training Fellowship in Substance use and Addiction (RTFSA)T32DA007238 · NIDA · YALE UNIVERSITY · PI BRIAN D. KILUK, ISMENE L. PETRAKIS · 1988 to 2026
$5.7M
Translational Neuroscience Research in Alcoholism (TNRA-TP)T32AA015496 · NIAAA · YALE UNIVERSITY · PI PETRAKIS, ISMENE L. · 2005 to 2014
$1.6M
Does Guanfacine, an alpha2 adrenergic agonist, attenuate stress-induced drinking?R01AA022285 · NIAAA · YALE UNIVERSITY · PI MCKEE, SHERRY ANN · 2014 to 2017
$1.5M
Dose ranging study of varenicline on human alcohol self-administration behaviorR01AA017976 · NIAAA · YALE UNIVERSITY · PI MCKEE, SHERRY ANN · 2009 to 2011
$1.0M
NIAAA NIH HHS R01 AA017976NIAAA NIH HHS R01 AA022285NIAAA NIH HHS T32 AA015496NIDA NIH HHS T32 DA007238
6 · The paper itself

Abstract

objectivesVarenicline (2 mg/d) has been shown to be efficacious in reducing alcohol consumption. A lower dose of varenicline may be effective in reducing alcohol use while minimizing the potential for side effects.

methodsThis double-blind, placebo-controlled investigation examined the effect of varenicline (0, 1, 2 mg/d) on alcohol consumption in nontreatment-seeking adults meeting the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for alcohol use disorders (N = 60). Following 7 days of medication pretreatment, participants were administered a low fixed dose of alcohol (0.3 g/dL), and subjective and physiologic responses were assessed. A 2-hour ad libitum alcohol self-administration period followed. We also explored relationships between plasma varenicline levels and consumption.

resultsOverall, frequency and severity of adverse events were minimal. The 1 mg/d dose reduced the frequency of insomnia compared with the 2 mg/d dose. The 2 mg/d varenicline dose versus placebo reduced alcohol craving and showed limited effect on reduced alcohol consumption. Alcohol craving and consumption did not differ between the 1 mg/d varenicline dose versus placebo. Trough varenicline plasma levels greater than or equal to 3 ng/mL were associated with reduced drinking and levels greater than or equal to 5 ng/mL were associated with reduced heavy drinking.

conclusionsOverall, we found no evidence supporting an effect of 1 mg/d varenicline on craving or consumption, suggesting that doses of varenicline less than 2 mg/d may not be effective in reducing alcohol-related outcomes. Importantly, results suggest that higher plasma levels of varenicline may be needed to maximize the effect of varenicline on alcohol consumption and should be investigated in drinkers meeting criteria for alcohol use disorders.

Indexed as

Outcome Assessment, Health CareAdultAlcohol-Related DisordersDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedNicotinic AgonistsVareniclineNicotinic AgonistsVarenicline

Identifiers

PMID27159341
PMCPMC4880525

What OpenQuestion holds

Textmetadata
LicenceTDM
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.