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

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

Background: Tramadol 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. Methods: Prescription 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. Results: Use of breakthrough withdrawal medication differed significantly (p< 0.05) among groups in both phases; the 200. mg group received the least amount in Phase 1, and the 600. mg group received the most in both phases. In Phase 1, tramadol 200. mg 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. Conclusions: ER tramadol 200. mg 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.

Original languageEnglish
Pages (from-to)188-197
Number of pages10
JournalDrug and Alcohol Dependence
Volume133
Issue number1
DOIs
StatePublished - Nov 1 2013

Bibliographical note

Funding Information:
This study was supported by the National Institute on Drug Abuse (NIDA) R01 DA027068 (MRL) and T32 DA007304 and by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health grant UL1RR033173 . NIDA had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Keywords

  • Efficacy
  • Opioid withdrawal
  • Prescription opioid dependence
  • Randomized clinical trial
  • Tramadol
  • Treatment

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)

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