Evidence map›Paper›PMID 21270789›Full record

Trial reportClinical pharmacology and therapeutics2011

Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films.

E C Strain, J A Harrison, G E Bigelow

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740243 (Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 3% 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.

NCT03740243 phase4withdrawnnot on this mapstarted 2018, after this paper: background citation

Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

TypeinterventionalSponsorStony Brook UniversityRan2018 to 2020Enrolled0ConditionsOpioid-use DisorderArmsBuprenorphine/naloxone, Buprenorphine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Pharmacological therapies for management of opium withdrawal.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
  4. Review
  5. Review
  6. 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 · 2018
    Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Thermal sensitivity as a measure of spontaneous morphine withdrawal in mice.Journal of pharmacological and toxicological methods
    Article
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

E C StrainDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA. estrain1@jhmi.edu
J A Harrison
G E Bigelow
Johns Hopkins University · US

Funding

EVALUATION OF OPIOID ANTAGONIST ACTIVITY IN HUMANSR01DA008045 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 1994 to 2010
$5.3M
Mentoring of Clinical Investigators in Patient Oriented ResearchK24DA023186 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 2007 to 2016
$1.8M
NIDA NIH HHS DA023186NIDA NIH HHS DA08045NIDA NIH HHS K24 DA023186NIDA NIH HHS R01 DA008045
6 · The paper itself

Abstract

A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.

Indexed as

Administration, SublingualAdultBuprenorphineBuprenorphine, Naloxone Drug CombinationDouble-Blind MethodDrug ApprovalDrug PackagingFemaleHumansMaleMedication SystemsMiddle AgedNaloxoneNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersBuprenorphineBuprenorphine, Naloxone Drug CombinationNaloxoneNarcotic AntagonistsTablets

Identifiers

PMID21270789
PMCPMC3225026
OpenAlexW2065431063

What OpenQuestion holds

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Read underepoch 390

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.