Evidence map›Paper›PMID 38408060›Full record

Trial reportPloS one2024

Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems.

Judith I Tsui, Sarah L Rossi, Debbie M Cheng, Sally Bendiks, Marina Vetrova, Elena Blokhina, Michael Winter, Natalia Gnatienko, Miroslav Backonja, Kendall Bryant and 2 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 9% 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, 2 syntheses or guidelines pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. 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

12 authors at 6 institutions in 2 countries.

Judith I TsuiDepartment of Medicine, Division of General Internal Medicine University of Washington School of Medicine/Harborview Medical Center, Seattle, Washington, United States of America.ORCID 0000-0003-0877-5399
Sarah L RossiDepartment of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, Massachusetts, United States of America.ORCID 0000-0002-4168-5267
Debbie M ChengDepartment of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, Unites States of America.
Sally BendiksDepartment of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, Massachusetts, United States of America.
Marina VetrovaPavlov University, St. Petersburg, Russian Federation.
Elena BlokhinaPavlov University, St. Petersburg, Russian Federation.
Michael WinterBiostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts, United States of America.
Natalia GnatienkoDepartment of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, Massachusetts, United States of America.
Miroslav BackonjaNational Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Maryland, United States of America.
Kendall BryantHIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland, United States of America.
Evgeny KrupitskyPavlov University, St. Petersburg, Russian Federation.ORCID 0000-0002-0529-4525
Jeffrey H SametDepartment of Medicine, Section of General Internal Medicine, Boston University School of Medicine/Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, Massachusetts, United States of America.
Boston Medical Center · USBoston University · USFirst Pavlov State Medical University of St. Petersburg · RUNational Institute on Alcohol Abuse and Alcoholism · USNational Institutes of Health · USUniversity of Washington · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Translational ScienceP30AI042853 · NIAID · MIRIAM HOSPITAL · PI CURT G BECKWITH, DEBBIE M. CHENG · 1998 to 2026
$51.7M
URBAN ARCH (2/5) Biostatistics and Data Management Core (BDM)U24AA020779 · NIAAA · BOSTON UNIVERSITY MEDICAL CAMPUS · PI CHENG, DEBBIE M. · 2011 to 2020
$3.6M
URBAN ARCH (1/5) Administrative Coordinating Core (Admin Core)U24AA020778 · NIAAA · BOSTON MEDICAL CENTER · PI SAMET, JEFFREY H. · 2011 to 2020
$3.5M
Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation among HIV-Infected Persons with Alcohol ProblemsUH3AA026193 · NIAAA · BOSTON MEDICAL CENTER · PI SAMET, JEFFREY H., TSUI, JUDITH · 2019 to 2021
$1.0M
Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation among HIV-Infected Persons with Alcohol ProblemsUH2AA026193 · NIAAA · BOSTON MEDICAL CENTER · PI SAMET, JEFFREY H., TSUI, JUDITH · 2017 to 2018
$385k
NIAAA NIH HHS U24 AA020778NIAAA NIH HHS U24 AA020779NIAAA NIH HHS UH2 AA026193NIAAA NIH HHS UH3 AA026193NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI042853
6 · The paper itself

Abstract

backgroundTo estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain.

methodsWe conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks.

resultsParticipants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively.

conclusionNeither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use. CLINICAL

trial registrationClinicalTrials.gov (NCT4052139).

Indexed as

Alcohol-Related DisordersChronic PainHIV InfectionsAdultDouble-Blind MethodFemaleGabapentinHumansMaleMiddle AgedNaltrexonePain ManagementTreatment OutcomeGabapentinNaltrexone

Identifiers

PMID38408060
PMCPMC10896547
OpenAlexW4392154069

What OpenQuestion holds

Textmetadata
LicenceCC0
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.