Evidence map›Paper›PMID 24602363›Full record

Trial reportDrug and alcohol dependence2014

Extended release naltrexone injection is performed in the majority of opioid dependent patients receiving outpatient induction: a very low dose naltrexone and buprenorphine open label trial.

Paolo Mannelli, Li-Tzy Wu, Kathleen S Peindl, Marvin S Swartz, George E Woody

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 5% 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

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Opioid antagonists with minimal sedation for opioid withdrawal.The Cochrane database of systematic reviews · 2017
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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 2 institutions in 1 country.

Paolo MannelliDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States. Electronic address: paolo.mannelli@duke.edu.
Li-Tzy WuDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Kathleen S PeindlDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Marvin S SwartzDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
George E WoodyDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Duke Medical Center · USDuke University Hospital · US

Funding

Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ronald G Collman · 1999 to 2026
$78.6M
Southern Consortium Node of the Clinical Trials NetworkU10DA013727 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2000 to 2015
$34.4M
Delaware Valley Node of the Clinical Trials NetworkU10DA013043 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI WOODY, GEORGE EDWARD · 1999 to 2015
$25.8M
Substance Abuse & Treatment Gaps in Asians, Pacific Islanders & Multiple-race IndR01MD007658 · NIMHD · DUKE UNIVERSITY · PI WU, LI-TZY · 2013 to 2017
$1.8M
Treatment/Substance Use Disorders/HIV Risk ReductionK05DA017009 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI WOODY, GEORGE EDWARD · 2003 to 2012
$1.3M
MDMA and Other Hallucinogen Use: Onset and Abuse/DependenceR01DA019623 · NIDA · DUKE UNIVERSITY · PI WU, LI-TZY · 2007 to 2013
$1.1M
Classification of Substance Use Severity and Treatment Outcomes: NIDA CTN StudiesR33DA027503 · NIDA · DUKE UNIVERSITY · PI WU, LI-TZY · 2010 to 2012
$1.1M
NIAID NIH HHS P30 AI045008NIDA NIH HHS K05 DA017009NIDA NIH HHS KO5DA-17009NIDA NIH HHS R01 DA019623NIDA NIH HHS R01DA019623NIDA NIH HHS R33 DA027503NIDA NIH HHS R33DA027503NIDA NIH HHS U10 DA013043NIDA NIH HHS U10DA013727NIDA NIH HHS U10DA-13043NIMHD NIH HHS R01 MD007658NIMHD NIH HHS R01MD007658
6 · The paper itself

Abstract

backgroundThe approval of extended release injectable naltrexone (XR-NTX; Vivitrol(®)) has introduced a new option for treating opioid addiction, but studies are needed to identify its place within the spectrum of available therapies. The absence of physiological opioid dependence is a necessary and challenging first step for starting XR-NTX. Outpatient detoxification gives poor results and inpatient detoxification is either unavailable or too brief for the physiological effects of opioids to resolve. Here we present findings from an open label study that tested whether the transition from opioid addiction to XR-NTX can be safely and effectively performed in an outpatient setting using very low dose naltrexone and buprenorphine.

methodsTwenty treatment seeking opioid addicted individuals were given increasing doses of naltrexone starting at 0.25mg with decreasing doses of buprenorphine starting at 4 mg during a 7-day outpatient XR-NTX induction procedure. Withdrawal discomfort, craving, drug use, and adverse events were assessed daily until the XR-NTX injection, then weekly over the next month.

resultsFourteen of the 20 participants received XR-NTX and 13 completed weekly assessments. Withdrawal, craving, and opioid or other drug use were significantly lower during induction and after XR-NTX administration compared with baseline, and no serious adverse events were recorded.

conclusionsOutpatient transition to XR-NTX combining upward titration of very low dose naltrexone with downward titration of low dose buprenorphine was safe, well tolerated, and completed by most participants. Further studies with larger numbers of subjects are needed to see if this approach is useful for naltrexone induction.

Indexed as

AdultBuprenorphineCravingDelayed-Action PreparationsDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansInjections, IntramuscularMaleMiddle AgedNaltrexoneNarcotic AntagonistsOpioid-Related DisordersOutpatientsSubstance Withdrawal SyndromeBuprenorphineDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsAddictionDetoxificationMinority recruitmentOpioid agonistOpioid antagonistPharmacotherapy

Identifiers

PMID24602363
PMCPMC4017322
OpenAlexW1988132987

What OpenQuestion holds

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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.