Evidence map›Paper›PMID 30079432›Full record

Trial reportPsychopharmacology2018

Assessment of pioglitazone and proinflammatory cytokines during buprenorphine taper in patients with opioid use disorder.

Jennifer R Schroeder, Karran A Phillips, David H Epstein, Michelle L Jobes, Melody A Furnari, Ashley P Kennedy, Markus Heilig, Kenzie L Preston

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01517165 (Pioglitazone as an Aid During Buprenorphine Taper), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.3field-weighted citation impact, top 23% 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.

NCT01517165 phase1terminatednot on this map

Pioglitazone as an Aid During Buprenorphine Taper

TypeinterventionalSponsorNational Institute on Drug Abuse (NIDA)Ran2012 to 2015Enrolled24ConditionsOpioid-Related DisordersArmsPioglitazone, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  4. Article
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  6. Article
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  8. Article
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  11. Article
  12. Review
  13. Neuroimmune signaling in alcohol use disorder.Pharmacology, biochemistry, and behavior · 2019
    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

8 authors at 3 institutions in 2 countries.

Jennifer R SchroederJohns Hopkins Bayview Medical Center, Baltimore, MD, 21224, USA.
Karran A PhillipsNational Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.
David H EpsteinNational Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.
Michelle L JobesNational Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.
Melody A FurnariNational Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.
Ashley P KennedyNational Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.
Markus HeiligCenter for Social and Affective Neuroscience, IKE, Linköping Univ, 58183, Linköping, Sweden.
Kenzie L PrestonNational Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA. kpreston@intra.nida.nih.gov.ORCID http://orcid.org/0000-0003-0603-2479
National Institutes of Health · USJohns Hopkins University · USLinköping University · SE

Funding

Real-Time Assessment of Drug Use, Along with Mental States and EnvironmentsZIADA000499 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI EPSTEIN, DAVID · 2009 to 2025
$19.9M
New approaches to addiction treatmentZIADA000624 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI EPSTEIN, DAVID · 2018 to 2025
$9.6M
Prevention of Relapse in AddictionZ01DA000536 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI PRESTON, KENZIE · 2007 to 2008
$2.3M
Intramural NIH HHS ZIA DA000624NIDA NIH HHS Z01 DA000536
6 · The paper itself

Abstract

backgroundPreliminary evidence suggested that the PPARγ agonist pioglitazone reduces opioid-withdrawal symptoms, possibly by inhibiting increases in proinflammatory cytokines.

methodsA randomized, placebo-controlled clinical trial was conducted utilizing two different study designs (entirely outpatient, and a combination of inpatient and outpatient) to evaluate the safety and efficacy of pioglitazone as an adjunct medication for people with opioid physical dependence undergoing a buprenorphine taper. Participants were stabilized on buprenorphine/naloxone (sublingual, up to 16/4 mg/day), then randomized to receive oral pioglitazone (up to 45 mg/day) or placebo before, during, and after buprenorphine taper. Outcome measures included the Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale, use of rescue medications to alleviate opioid withdrawal symptoms, and opioid-positive urine specimens. Cerebrospinal fluid (CSF) and plasma were collected during the taper in a subset of participants for measurement of proinflammatory cytokines.

resultsThe clinical trial was prematurely terminated due to slow enrollment; 40 participants per group were required for adequate statistical power to test study hypotheses. Twenty-four participants enrolled; 17 received at least one dose of study medication (6 pioglitazone, 11 placebo). SOWS scores were higher in the pioglitazone arm than in the placebo arm after adjusting for use of rescue medications; participants in the pioglitazone arm needed more rescue medications than the placebo arm during the post-taper phase. SOWS scores were positively correlated with monocyte chemoattractant protein-1 (MCP-1) in CSF (r = 0.70, p = 0.038) and plasma (r = 0.77, p = 0.015). Participants having higher levels of plasma MCP-1 reported higher SOWS, most notably after the buprenorphine taper ended.

conclusionsResults from this study provide no evidence that pioglitazone reduces opioid withdrawal symptoms during buprenorphine taper. High correlations between MCP-1 and opioid withdrawal symptoms support a role of proinflammatory processes in opioid withdrawal.

trial registrationclinicaltrials.gov identifier: NCT01517165.

Indexed as

AdultAnalgesics, OpioidBuprenorphineCytokinesDouble-Blind MethodFemaleHumansMaleMiddle AgedNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPioglitazoneSubstance Withdrawal SyndromeAnalgesics, OpioidBuprenorphineCytokinesNarcotic AntagonistsPioglitazoneBuprenorphineCytokinesOpioid dependenceOpioid withdrawalPioglitazone

Identifiers

PMID30079432
PMCPMC7286070
OpenAlexW2886925611

What OpenQuestion holds

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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.