Evidence map›Paper›PMID 34120336›Full record

Trial reportAlcoholism, clinical and experimental research2021

Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder.

John J Mariani, Martina Pavlicova, Cale Basaraba, Agnieszka Mamczur-Fuller, Daniel J Brooks, Adam Bisaga, Kenneth M Carpenter, Edward V Nunes, Frances R Levin

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Cyclic Nucleotide Phosphodiesterases in Alcohol Use Disorders: Involving Gut Microbiota.The international journal of neuropsychopharmacology · 2023
    Article
  6. 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

9 authors at 4 institutions in 1 country.

John J MarianiDivision on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.ORCID 0000-0002-9535-7744
Martina PavlicovaDepartment of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.
Cale BasarabaMental Health Data Science Division, New York State Psychiatric Institute, New York, NY, USA.
Agnieszka Mamczur-FullerSupervised Release Program, New York City Criminal Justice Agency, New York, NY, USA.
Daniel J BrooksDivision on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Adam BisagaDivision on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Kenneth M CarpenterDivision on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Edward V NunesDivision on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Frances R LevinDivision on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
New York State Department of State · USColumbia University · USNew York City Police Department · USNew York State Office of Mental Health · US

Funding

PHARMACOLOGICAL TREATMENT OF MARIJUANA DEPENDENCEP50DA009236 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI KLEBER, HERBERT DAVID · 1994 to 2013
$39.4M
Drug Abuse Treatment Development and Research MentoringK24DA022412 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI NUNES, EDWARD V. · 2007 to 2016
$1.7M
Anticonvulsant Pharmacotherapy for Sedative-Hypnotic Use DisordersK23DA021209 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MARIANI, JOHN J · 2006 to 2010
$884k
Gabapentin for Abstinence Initiation in Alcohol DependenceR21AA017691 · NIAAA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI MARIANI, JOHN J · 2010 to 2011
$432k
NIAAA NIH HHS R21 AA017691NIDA NIH HHS K23 DA021209NIDA NIH HHS K24 DA022412NIDA NIH HHS P50 DA009236
6 · The paper itself

Abstract

backgroundDespite advances in the development of pharmacotherapy for alcohol use disorder (AUD), there remains a need for medications that can be administered to actively drinking outpatients to promote a reduction in harmful alcohol consumption. The primary aim of this pilot study was to determine whether high-dose gabapentin (3600 mg/daily) is more effective than placebo in reducing harmful alcohol consumption in outpatients with AUD.

methodsForty patients (27 men) who met DSM-IV-TR criteria for alcohol dependence and reporting at least 4 heavy drinking days (HDD) per week were recruited at a single site. Participants were actively drinking at study entry and received double-blind gabapentin (3600 mg/day; n = 19) or placebo (n = 20) for 8 weeks. Study medication was titrated over 5 days and administered in three divided doses (1200 mg three times per day). The proportion of HDD (primary outcome) and percent days abstinent (PDA; secondary outcome) were analyzed using generalized longitudinal mixed models with the predictors being study arm, week, study arm by week interaction, and corresponding baseline drinking measure.

resultsThere was a significant interaction between study arm and week for the proportion of HDD per week, F (7, 215) = 3.33, p = 0.002 . There was also a significant interaction between study arm and week for PDA per week, F (7, 215) = 3.11, p = 0.004. The overall retention rate was 67.5% with no significant difference in time-to-dropout between treatment groups. There were no serious adverse events. No participants were removed from the trial due to the development of moderate-to-severe alcohol withdrawal (CIWA-Ar ≥ 13).

conclusionsGabapentin treatment rapidly titrated to a dosage of 3600 mg/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD. High-dose gabapentin is potentially a feasible approach to treating AUD and deserving of further study.

Indexed as

AdultAlcoholismAnticonvulsantsDrug MonitoringFemaleGabapentinHumansMaleMiddle AgedPatient DropoutsPilot ProjectsAnticonvulsantsGabapentinalcohol use disordergabapentinpharmacotherapy

Identifiers

PMID34120336
PMCPMC8462978
OpenAlexW3168295476

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.