Evidence map›Paper›PMID 33225963›Full record

Trial reportTrials2020

A novel human laboratory model for screening medications for alcohol use disorder.

Diana Ho, Brandon Towns, Erica N Grodin, Lara A Ray

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04249882 (A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT04249882 phase2completednot on this map

A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder

TypeinterventionalSponsorUniversity of California, Los AngelesRan2020 to 2022Enrolled53ConditionsAlcohol Use DisorderArmsPlacebo, Naltrexone, Varenicline
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Influence of sleep quality on lapse to alcohol use during a quit attempt.Alcohol and alcoholism (Oxford, Oxfordshire) · 2024
    Trial
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

4 authors.

Diana HoDepartment of Psychology, University of California, Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.
Brandon TownsDepartment of Psychology, University of California, Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.
Erica N GrodinDepartment of Psychology, University of California, Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.
Lara A RayDepartment of Psychology, University of California, Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA. lararay@psych.ucla.edu.

Funding

A NOVEL HUMAN LABORATORY MODEL FOR SCREENING MEDICATIONS FOR ALCOHOL USE DISORDERR21AA027180 · NIAAA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI RAY, LARA A. · 2019 to 2021
$540k
NIAAA NIH HHS R21 AA027180NIAAA NIH HHS R21AA027180
6 · The paper itself

Abstract

backgroundAlcohol use disorder (AUD) is a highly prevalent, chronic relapsing disorder with a high disease burden in the USA. Pharmacotherapy is a promising treatment method for AUD; however, the few FDA-approved medications are only modestly effective. Medications development for AUD is a high priority research area, but the cumbersome drug development process hinders many potential compounds from reaching approval. One area with major opportunities for improvement is the process of screening novel compounds for initial efficacy, also known as early phase 2 trials. Early phase 2 trials incorporate human laboratory paradigms to assess relevant clinical constructs, such as craving and subjective responses to alcohol. However, these controlled paradigms often lack the ecological validity of clinical trials. Therefore, early phase 2 trials can be more efficient and clinically meaningful if they combine the internal validity of experimental laboratory testing with the external validity of clinical trials. To that end, the current study aims to develop and validate a novel early efficacy paradigm, informed by smoking cessation literature, to screen novel medications for AUD. As an established AUD medication, naltrexone will serve as an active control to test both the practice quit attempt model and the efficacy of a promising AUD pharmacotherapy, varenicline.

methodsIndividuals with current AUD reporting intrinsic motivation to change their drinking will complete a week-long "practice quit attempt" while on study medication. Participants are randomized and blinded to either naltrexone, varenicline, or placebo. During the practice quit attempt, participants will complete daily visits over the phone and fill out online questionnaires regarding their drinking, alcohol craving, and mood. Additionally, participants will undergo two alcohol cue-reactivity sessions. DISCUSSION: The successful completion of this study will advance medications development by proposing and validating a novel early efficacy model for screening AUD pharmacotherapies, which in turn can serve as an efficient strategy for making go/no-go decisions as to whether to proceed with clinical trials.

trial registrationClinicalTrials.gov NCT04249882 . Registered on 31 January 2020.

Indexed as

AlcoholismAlcohol DrinkingHumansLaboratoriesNaltrexoneVareniclineNaltrexoneVareniclineAlcohol use disorderClinical trialMedications developmentMedications screeningNaltrexoneVarenicline

Identifiers

PMID33225963
PMCPMC7681966

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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.