Evidence map›Paper›PMID 27269956›Full record

Trial reportJournal of clinical psychopharmacology2016

Safety of Intravenous Methamphetamine Administration During Ibudilast Treatment.

Dustin Z DeYoung, Keith G Heinzerling, Aimee-Noelle Swanson, John Tsuang, Benjamin A Furst, Yi Yi, Ying Nian Wu, David E Moody, David M Andrenyak, Steven J Shoptaw

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04631471 (Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.0field-weighted citation impact, top 15% 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.

NCT04631471 phase3recruitingnot on this mapstarted 2021, after this paper: background citation

Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy

TypeinterventionalSponsorCambridge University Hospitals NHS Foundation TrustRan2021 to 2026Enrolled400ConditionsMyelopathy, Spinal Cord DiseasesArmsIbudilast, Cervical decompressive surgery, Matching placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Randomized, Placebo-Controlled Trial of Targeting Neuroinflammation with Ibudilast to Treat Methamphetamine Use Disorder.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2020
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Chemokines, cytokines and substance use disorders.Drug and alcohol dependence · 2021
    Review
  14. Article
  15. A Mutation inThe Journal of neuroscience : the official journal of the Society for Neuroscience · 2020
    Article
  16. Review
  17. 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

10 authors at 1 institution in 1 country.

Dustin Z DeYoungFrom the *Center for Behavioral and Addiction Medicine, Department of Family Medicine, David Geffen School of Medicine at UCLA, Los Angeles; †Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford; ‡Department of Psychiatry, Harbor-UCLA Medical Center, Torrance; §Department of Statistics, University of California, Los Angeles, CA; and ∥Center for Human Toxicology, Department of Pharmacology and Toxicology, University of Utah, Salt Lake City, UT.
Keith G Heinzerling
Aimee-Noelle Swanson
John Tsuang
Benjamin A Furst
Yi Yi
Ying Nian Wu
David E Moody
David M Andrenyak
Steven J Shoptaw
UCLA Medical Center · US

Funding

Phase I Safety Interaction Trial of Ibudilast with MethamphetamineR01DA029804 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SHOPTAW, STEVEN J · 2010 to 2012
$1.1M
NIDA NIH HHS R01 DA029804
6 · The paper itself

Abstract

backgroundMethamphetamine dependence is a significant public health concern without any approved medications for treatment. We evaluated ibudilast, a nonselective phosphodiesterase inhibitor, to assess the safety and tolerability during intravenous methamphetamine administration. We conducted a randomized, double-blind, placebo-controlled, within-subjects crossover clinical trial.

methodsParticipants received ibudilast (20 mg twice daily followed by 50 mg twice daily) and placebo, with order determined by randomization, and then underwent intravenous methamphetamine challenges (15 and 30 mg). We monitored cardiovascular effects, methamphetamine pharmacokinetics, and reported adverse events.

resultsIbudilast treatment had similar rates of adverse events compared with placebo, and there was no significant augmentation of cardiovascular effects of methamphetamine. Pharmacokinetic analysis revealed no clinically significant change in maximum concentration or half-life of methamphetamine with ibudilast.

conclusionsMethamphetamine administration during ibudilast treatment was well tolerated without additive cardiovascular effects or serious adverse events, providing initial safety data to pursue ibudilast's effectiveness for the treatment of methamphetamine dependence.

Indexed as

Central Nervous System StimulantsMethamphetamineOutcome Assessment, Health CareAdministration, IntravenousAdultAmphetamine-Related DisordersCross-Over StudiesDouble-Blind MethodFemaleHumansIndolizinesMaleMiddle AgedPhosphodiesterase InhibitorsPyrazolesPyridinesCentral Nervous System StimulantsibudilastIndolizinesMethamphetaminePhosphodiesterase InhibitorsPyrazolesPyridines

Identifiers

PMID27269956
PMCPMC4927401
OpenAlexW2418272444

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.