Trial reportDrug and alcohol dependence2008
A Phase 3 placebo-controlled, double-blind, multi-site trial of the alpha-2-adrenergic agonist, lofexidine, for opioid withdrawal.
Trial report in Drug and alcohol dependence, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled 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.
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
32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- A systematic review of brief, freely accessible, and valid self-report measures for substance use disorders and treatment.Drug and alcohol dependence · 2023Pooled it
- Pharmacological therapies for management of opium withdrawal.The Cochrane database of systematic reviews · 2018Pooled it
- Alpha₂-adrenergic agonists for the management of opioid withdrawal.The Cochrane database of systematic reviews · 2016Pooled it
- Gabapentin and D-cycloserine alone and in combination with naloxone in methadone-maintained humans responding under a naloxone novel-response discrimination procedure.Behavioural pharmacology · 2025Trial
- Sublingual dexmedetomidine (BXCL501) reduces opioid withdrawal symptoms: findings from a multi-site, phase 1b/2, randomized, double-blind, placebo-controlled trial.The American journal of drug and alcohol abuse · 2023Trial
- Guanfacine extended-release for cannabis use disorder: a pilot feasibility trial.The American journal of drug and alcohol abuse · 2020Trial
- Assessment of safety, cardiovascular and subjective effects after intravenous cocaine and lofexidine.Progress in neuro-psychopharmacology & biological psychiatry · 2014Trial
- Comparative profiles of men and women with opioid dependence: results from a national multisite effectiveness trial.The American journal of drug and alcohol abuse · 2011Trial
- Safety and Efficacy of Lofexidine for Medically Managed Opioid Withdrawal: A Randomized Controlled Clinical Trial.Journal of addiction medicineTrial
- A Scoping Review of Non-Opioid Therapeutics for Opioid Withdrawal: Translational Relevance to Neonatal Opioid Withdrawal Syndrome (NOWS) Research.Clinical and translational science · 2026Article
- Review
- Adrenoceptors: A Focus on Psychiatric Disorders and Their Treatments.Handbook of experimental pharmacology · 2024Review
- Treatment of Opioid Withdrawal Syndrome Triggered by Oxycodone/Naloxone with Dexmedetomidine.Journal of hospice and palliative care · 2023Article
- Noradrenergic circuits and signaling in substance use disorders.Neuropharmacology · 2022Review
- Improving Translational Research Outcomes for Opioid Use Disorder Treatments.Current addiction reports · 2021Article
- Lofexidine for acute opioid withdrawal: A clinical case series.The mental health clinician · 2020Article
- The role of catecholamines in modulating responses to stress: Sex-specific patterns, implications, and therapeutic potential for post-traumatic stress disorder and opiate withdrawal.The European journal of neuroscience · 2020Review
- Efficacy of lofexidine for mitigating opioid withdrawal symptoms: results from two randomized, placebo-controlled trials.Journal of drug assessment · 2020Article
- Stress, craving and mood as predictors of early dropout from opioid agonist therapy.Drug and alcohol dependence · 2019Article
- The Role of Lofexidine in Management of Opioid Withdrawal.Pain and therapy · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 6 institutions in 1 country.
Funding
Abstract
contextLofexidine is an alpha-2-adrenergic receptor agonist that is approved in the United Kingdom for the treatment of opioid withdrawal symptoms. Lofexidine has been reported to have more significant effects on decreasing opioid withdrawal symptoms with less hypotension than clonidine.
objectiveTo demonstrate that lofexidine is well tolerated and effective in the alleviation of observationally defined opioid withdrawal symptoms in opioid dependent individuals undergoing medically supervised opioid detoxification as compared to placebo.
designAn inpatient, Phase 3, placebo-controlled, double-blind, randomized multi-site trial with three phases: (1) opioid agonist stabilization phase (days 1-3), (2) detoxification/medication or placebo phase (days 4-8), and (3) post detoxification/medication phase (days 9-11). SUBJECTS: Sixty-eight opioid dependent subjects were enrolled at three sites with 35 randomized to lofexidine and 33 to placebo.
main outcome measureModified Himmelsbach Opiate Withdrawal Scale (MHOWS) on study day 5 (second opioid detoxification treatment day).
resultsDue to significant findings, the study was terminated early. On the study day 5 MHOWS, subjects treated with lofexidine had significantly lower scores (equating to fewer/less severe withdrawal symptoms) than placebo subjects (least squares means 19.5+/-2.1 versus 30.9+/-2.7; p=0.0019). Lofexidine subjects had significantly better retention in treatment than placebo subjects (38.2% versus 15.2%; Log rank test p=0.01).
conclusionsLofexidine is well tolerated and more efficacious than placebo for reducing opioid withdrawal symptoms in inpatients undergoing medically supervised opioid detoxification.
Indexed as
Identifiers
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.