Evidence map›Paper›PMID 23755929›Full record

Trial reportDrug and alcohol dependence2013

Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial.

Michelle R Lofwall, Shanna Babalonis, Paul A Nuzzo, Anthony Siegel, Charles Campbell, Sharon L Walsh

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

Trial report in Drug and alcohol dependence, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00980044 (Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 13% 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.

NCT00980044 phase2 / phase3completednot on this map

Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

TypeinterventionalSponsorMichelle LofwallRan2009 to 2012Enrolled53ConditionsSubstance Withdrawal SyndromeArmsTramadol, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Pleasure, addiction, and hypocretin (orexin).Handbook of clinical neurology · 2021
    Review
  11. Article
  12. Review
  13. Article
  14. Maintainence Treatment of Opioid Dependence with Tramadol.Journal of neurosciences in rural practice · 2017
    Article
  15. Article
  16. 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

6 authors at 2 institutions in 1 country.

Michelle R LofwallUniversity of Kentucky (UK), Department of Psychiatry, Lexington, KY 40509, USA; UK, Department of Behavioral Science, Lexington, KY 40502, USA; UK, Center on Drug and Alcohol Research, Lexington, KY 40502, USA. Electronic address: michelle.lofwall@uky.edu.
Shanna Babalonis
Paul A Nuzzo
Anthony Siegel
Charles Campbell
Sharon L Walsh
University of Kentucky · USUniversity of Kentucky HealthCare · US

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR000117 · NCATS · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2012 to 2015
$13.3M
KENTUCKY CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCEUL1RR033173 · NCRR · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2011 to 2011
$3.5M
RESEARCH TRAINING IN DRUG ABUSE BEHAVIORT32DA007304 · NIDA · UNIVERSITY OF KENTUCKY · PI RUSH, CRAIG R · 1998 to 2012
$3.1M
Efficacy of Extended Release Tramadol for Treating Prescription Opioid WithdrawalR01DA027068 · NIDA · UNIVERSITY OF KENTUCKY · PI LOFWALL, MICHELLE RENEE · 2009 to 2011
$1.1M
NCATS NIH HHS UL1 TR000117NCRR NIH HHS UL1 RR033173NIDA NIH HHS R01 DA027068NIDA NIH HHS T32 DA007304
6 · The paper itself

Abstract

backgroundTramadol is an atypical analgesic with monoamine and modest mu opioid agonist activity. The purpose of this study was to evaluate: (1) the efficacy of extended-release (ER) tramadol in treating prescription opioid withdrawal and (2) whether cessation of ER tramadol produces opioid withdrawal.

methodsPrescription opioid users with current opioid dependence and observed withdrawal participated in this inpatient, two-phase double blind, randomized placebo-controlled trial. In Phase 1 (days 1-7), participants were randomly assigned to matched oral placebo or ER tramadol (200 or 600 mg daily). In Phase 2 (days 8-13), all participants underwent double blind crossover to placebo. Breakthrough withdrawal medications were available for all subjects. Enrollment continued until 12 completers/group was achieved.

resultsUse of breakthrough withdrawal medication differed significantly (p<0.05) among groups in both phases; the 200mg group received the least amount in Phase 1, and the 600 mg group received the most in both phases. In Phase 1, tramadol 200mg produced significantly lower peak ratings than placebo on ratings of insomnia, lacrimation, muscular tension, and sneezing. Only tramadol 600 mg produced miosis in Phase 1. In Phase 2, tramadol 600 mg produced higher peak ratings of rhinorrhea, irritable, depressed, heavy/sluggish, and hot/cold flashes than placebo. There were no serious adverse events and no signal of abuse liability for tramadol.

conclusionsER tramadol 200mg modestly attenuated opioid withdrawal. Mild opioid withdrawal occurred after cessation of treatment with 600 mg tramadol. These data support the continued investigation of tramadol as a treatment for opioid withdrawal.

Indexed as

AdolescentAdultAnalgesics, OpioidCross-Over StudiesDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedOpioid-Related DisordersPrescription DrugsSubstance Withdrawal SyndromeTramadolAnalgesics, OpioidDelayed-Action PreparationsPrescription DrugsTramadolEfficacyOpioid withdrawalPrescription opioid dependenceRandomized clinical trialTramadolTreatment

Identifiers

PMID23755929
PMCPMC3786049
OpenAlexW2023709430

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.