Evidence map›Paper›PMID 17517480›Full record

Trial reportDrug and alcohol dependence2007

Sublingual buprenorphine/naloxone precipitated withdrawal in subjects maintained on 100mg of daily methadone.

James Rosado, Sharon L Walsh, George E Bigelow, Eric C Strain

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 10% 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

51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.

  1. Pooled it
  2. Management of opioid use disorders: a national clinical practice guideline.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    Guideline
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  12. Review
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  18. Early emergency department experience with 7-day extended-release injectable buprenorphine for opioid use disorder.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2023
    Article
  19. Article
  20. Article
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

4 authors at 2 institutions in 1 country.

James RosadoBehavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
Sharon L Walsh
George E Bigelow
Eric C Strain
Behavioral Pharma (United States) · USJohns Hopkins University · US

Funding

EVALUATION OF OPIOID ANTAGONIST ACTIVITY IN HUMANSR01DA008045 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 1994 to 2010
$5.3M
CLINICAL RESEARCH ON DRUG ABUSEK02DA000332 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 1997 to 2006
$884k
NIDA NIH HHS K02 DA000332NIDA NIH HHS K02 DA00332NIDA NIH HHS R01 DA008045NIDA NIH HHS R01 DA08045
6 · The paper itself

Abstract

rationaleAcute doses of buprenorphine can precipitate withdrawal in opioid dependent persons. The likelihood of this withdrawal increases as a function of the level of physical dependence.

objectivesTo test the acute effects of sublingual buprenorphine/naloxone tablets in volunteers with a higher level of physical dependence. The goal was to identify a dose that would precipitate withdrawal (Phase 1), then determine if withdrawal could be attenuated by splitting this dose (Phase 2).

methodsResidential laboratory study; subjects (N=16) maintained on 100mg per day of methadone. Phase 1: randomized, double blind, triple dummy, within subject study. Conditions were sublingual buprenorphine/naloxone (4/1, 8/2, 16/4, 32mg/8mg), intramuscular naloxone (0.2mg), oral methadone (100mg), or placebo. Medication conditions were randomized, but buprenorphine/naloxone doses were ascending within the randomization. Phase 2: Conditions were methadone, placebo, naloxone, 100% of the buprenorphine/naloxone dose that precipitated withdrawal in Phase 1 (full dose), and 50% of this dose administered twice in a session (split dose). Analyses covaried by trough methadone serum levels.

resultsSix subjects did not complete the study. Of the 10 who completed, 3 tolerated up to 32mg/8mg of buprenorphine/naloxone without evidence of precipitated withdrawal. For the seven completing both phases, split doses generally produced less precipitated withdrawal compared to full doses.

conclusionsThere is considerable between subject variability in sensitivity to buprenorphine's antagonist effects. Low, repeated doses of buprenorphine/naloxone (e.g., 2mg/0.5mg) may be an effective mechanism for safely dosing this medication in persons with higher levels of physical dependence.

Indexed as

Administration, SublingualAdultBuprenorphineCognition DisordersDouble-Blind MethodDrug CombinationsFemaleHumansMaleMethadoneMiddle AgedNaloxoneNeuropsychological TestsOpioid-Related DisordersPsychomotor DisordersSubstance Withdrawal SyndromeBuprenorphineDrug CombinationsMethadoneNaloxone

Identifiers

PMID17517480
PMCPMC2094723
OpenAlexW2060537745

What OpenQuestion holds

Textmetadata
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.