Evidence map›Paper›PMID 31820289›Full record

Trial reportJournal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology2020

Randomized, Placebo-Controlled Trial of Targeting Neuroinflammation with Ibudilast to Treat Methamphetamine Use Disorder.

Keith G Heinzerling, Marisa Briones, April D Thames, Charles H Hinkin, Tianle Zhu, Ying Nian Wu, Steven J Shoptaw

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 32% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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  12. Role of Microglia in Psychostimulant Addiction.Current neuropharmacology · 2023
    Review
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  18. Toll-Like Receptor 4: A Novel Target to Tackle Drug Addiction?Handbook of experimental pharmacology · 2022
    Article
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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

7 authors at 2 institutions in 1 country.

Keith G HeinzerlingDepartment of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. kheinzerling@mednet.ucla.edu.ORCID 0000-0001-9746-5821
Marisa BrionesDepartment of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
April D ThamesDepartment of Psychology, University of Southern California, Los Angeles, CA, USA.
Charles H HinkinDepartment of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, CA, USA.
Tianle ZhuDepartment of Statistics, UCLA, Los Angeles, CA, USA.
Ying Nian WuDepartment of Statistics, UCLA, Los Angeles, CA, USA.
Steven J ShoptawDepartment of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
University of California, Los Angeles · USUniversity of Southern California · US

Funding

Randomized Trial of Ibudilast for Methamphetamine DependenceR01DA035054 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI HEINZERLING, KEITH GREGORY · 2012 to 2017
$3.3M
NIDA NIH HHS DA035054NIDA NIH HHS R01 DA035054
6 · The paper itself

Abstract

Methamphetamine (MA) triggers neuroinflammation and medications that counteract MA-induced neuroinflammation may reduce MA-induced neurodegeneration and improve neurocognition and treatment outcomes in MA use disorder. We performed a randomized, placebo-controlled trial to determine the safety and efficacy of ibudilast (IBUD), a phosphodiesterase inhibitor that reduces neuroinflammation, for the treatment of MA use disorder. Treatment-seeking volunteers with MA use disorder were randomly assigned to receive 12 weeks of IBUD 50 mg twice daily (N = 64) or placebo (N = 61) with medication management counseling. Participants visited the outpatient research clinic twice weekly to provide urine specimens for drug screens and undergo study assessments. The primary outcome was end of treatment MA-abstinence (EOTA) during weeks 11 and 12 of treatment. Serum IBUID levels were measured for IBUD participants during week 3 of treatment. There was no difference in EOTA for IBUD (14%) versus placebo (16%, p > 0.05). There was no correlation between serum IBUD levels and MA use during treatment and mean IBUD levels for participants with (mean = 51.3, SD = 20.3) and without (mean = 54.7, SD = 33.0, p = 0.70) EOTA. IBUD was well tolerated. IBUD did not facilitate MA abstinence in this outpatient trial. Whether targeting neuroinflammation, either with IBUD in other subgroups of MA users or clinical trial designs, or with other anti-inflammatory medications, is an effective strategy for treating MA use disorder is not clear. Graphical Abstract The proportion of urine drug screens negative for methamphetamine (MA) during the two week lead-in period (weeks -2 and - 1) and the 12 week medication treatment period (weeks 1-12) for ibudilast versus placebo.

Indexed as

AdultAmphetamine-Related DisordersCentral Nervous System StimulantsDouble-Blind MethodFemaleHumansIndolizinesInflammation MediatorsMaleMethamphetamineMiddle AgedPhosphodiesterase InhibitorsPyrazolesPyridinesTreatment OutcomeCentral Nervous System StimulantsibudilastIndolizinesInflammation MediatorsMethamphetaminePhosphodiesterase InhibitorsPyrazolesPyridinesIbudilastMethamphetamineNeuroinflammationPlaceboRandomized clinical trials

Identifiers

PMID31820289
PMCPMC8651052
OpenAlexW2994833118

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.