Evidence map›Paper›PMID 22233189›Full record

Trial reportThe American journal of drug and alcohol abuse2012

The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal.

Paolo Mannelli, Kathleen Peindl, Li-Tzy Wu, Ashwin A Patkar, David A Gorelick

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of drug and alcohol abuse, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 28% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Opioid antagonists with minimal sedation for opioid withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Review
  3. Review
  4. Opioid Management: Initiating, Monitoring, and Tapering.Physical medicine and rehabilitation clinics of North America · 2020
    Review
  5. Article
  6. Intermittent blockade of OGFr and treatment of autoimmune disorders.Experimental biology and medicine (Maywood, N.J.) · 2018
    Review
  7. Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization.Medical sciences (Basel, Switzerland) · 2018
    Review
  8. Review
  9. Is it prime time for alpha2-adrenocepter agonists in the treatment of withdrawal syndromes?Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2014
    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

5 authors at 3 institutions in 1 country.

Paolo MannelliDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27705, USA. paolo.mannelli@duke.edu
Kathleen Peindl
Li-Tzy Wu
Ashwin A Patkar
David A Gorelick
Duke Medical Center · USDuke University Hospital · USNational Institutes of Health · US

Funding

Southern Consortium Node of the Clinical Trials NetworkU10DA013727 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2000 to 2015
$34.4M
Place of low-dose naltrexone in opiate detoxificationR21DA015469 · NIDA · THOMAS JEFFERSON UNIVERSITY · PI MANNELLI, PAOLO · 2003 to 2005
$557k
Intramural NIH HHSNIDA NIH HHS DA15469NIDA NIH HHS R21 DA015469NIDA NIH HHS U10 DA013727
6 · The paper itself

Abstract

backgroundThe management of withdrawal absorbs substantial clinical efforts in opioid dependence (OD). The real challenge lies in improving current pharmacotherapies. Although widely used, clonidine causes problematic adverse effects and does not alleviate important symptoms of opioid withdrawal, alone or in combination with the opioid antagonist naltrexone. Very low-dose naltrexone (VLNTX) has been shown to attenuate withdrawal intensity and noradrenaline release following opioid agonist taper, suggesting a combination with clonidine may result in improved safety and efficacy.

objectivesWe investigated the effects of a VLNTX-clonidine combination in a secondary analysis of data from a double-blind, randomized opioid detoxification trial.

methodsWithdrawal symptoms and treatment completion were compared following VLNTX (.125 or .25 mg/day) and clonidine (.1-.2 mg q6h) in 127 individuals with OD undergoing 6-day methadone inpatient taper at a community program.

resultsVLNTX was more effective than placebo or clonidine in reducing symptoms and signs of withdrawal. The use of VLNTX in combination with clonidine was associated with attenuated subjective withdrawal compared with each medication alone, favoring detoxification completion in comparison with clonidine or naltrexone placebo. VLNTX/clonidine was effective in reducing symptoms that are both undertreated and well controlled with clonidine treatment and was not associated with significant adverse events compared with other treatments. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Preliminary results elucidate neurobiological mechanisms of OD and support the utility of controlled studies on a novel VLNTX + low-dose clonidine combination for the management of opioid withdrawal.

Indexed as

AdolescentAdrenergic alpha-2 Receptor AgonistsAdultClonidineDisease ManagementDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHumansMaleMethadoneNaltrexoneNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersSubstance Withdrawal SyndromeAdrenergic alpha-2 Receptor AgonistsClonidineMethadoneNaltrexoneNarcotic Antagonists

Identifiers

PMID22233189
PMCPMC3578306
OpenAlexW2160053949

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.