Trial reportPharmacotherapy2009
Electrocardiographic effects of lofexidine and methadone coadministration: secondary findings from a safety study.
Trial report in Pharmacotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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.
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.
Who cites it
10 citing papers in PubMed, 24 citations in OpenAlex.
- Effect of lofexidine on cardiac repolarization during treatment of opioid withdrawal.Drug and alcohol dependence · 2019Trial
- The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal.The American journal of drug and alcohol abuse · 2012Trial
- Clonidine blocks stress-induced craving in cocaine users.Psychopharmacology · 2011Trial
- Review
- The Role of Lofexidine in Management of Opioid Withdrawal.Pain and therapy · 2019Review
- Pharmacologic Treatment of Opioid Use Disorder: a Review of Pharmacotherapy, Adjuncts, and Toxicity.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2018Review
- Drug-drug interactions and QT prolongation as a commonly assessed cardiac effect - comprehensive overview of clinical trials.BMC pharmacology & toxicology · 2016Review
- A systematic review of the cardiotoxicity of methadone.EXCLI journal · 2015Review
- Pharmacological strategies for detoxification.British journal of clinical pharmacology · 2014Review
- Cardiac Assessment of Individuals with Opioid Use Disorder under Methadone Treatment.Journal of research in pharmacy practiceArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
STUDY
objectiveTo determine the electrocardiographic effects of coadministration of lofexidine and methadone.
designProspective, double-blind study.
settingOutpatient drug treatment research clinic.
participantsFourteen adults (mean +/- SD age 34.9 +/- 5.3 yrs) with physical dependence on opioids.
interventionParticipants were stabilized on methadone maintenance therapy, reaching a target dose of 80 mg/day. After 3 weeks of methadone stabilization, participants received lofexidine 0.4 mg or placebo once/day, each for 1 week, administered at the same time as methadone. From weeks 3-8, all subjects received lofexidine, with the dose escalated each week in 0.2-mg increments so that by week 8, participants were receiving lofexidine 1.6 mg/day. Electrocardiograms (ECGs) were obtained at baseline (before methadone), after stabilization with methadone, and after lofexidine coadministration during peak plasma lofexidine levels. MEASUREMENTS AND MAIN
resultsPrespecified outcome measures of mean and maximal changes in heart rate, and PR, QRS, and QTc intervals were obtained after stabilization with methadone and after lofexidine 0.4 mg coadministration. Repeated-measures regression showed no significant changes in heart rate or PR, QRS, or QTc interval after methadone stabilization, but a significant decrease in heart rate (mean +/- SD -8.0 +/- 7.3 beats/min, p=0.0006) after starting lofexidine. When data were analyzed by using maximal ECG response, again, no significant changes were noted during methadone induction compared with baseline, but significant changes did occur in all four ECG parameters when lofexidine was coadministered: decreased heart rate (mean +/- SD -9.6 +/- 5.8 beats/min, p<0.0001) and increased PR interval (+11.1 +/- 19.8 msec, p=0.026), QRS interval (+3.7 +/- 4.3 msec, p=0.002), and QTc interval (+21.9 +/- 40.8 msec, p=0.018). In three female participants, the change in QTc interval from baseline was clinically significant (> 40 msec).
conclusionOur preliminary data suggest that coadministration of lofexidine and methadone induces QTc interval prolongation. This drug combination should be prescribed cautiously, with ECG monitoring. Furthermore, because the participants with the largest changes in QTc interval in our study were female, women may be at highest risk.
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What OpenQuestion holds
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.