Evidence map›Paper›PMID 32246728›Full record

Trial reportThe American journal on addictions2020

Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended-Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens.

Sandra D Comer, Paolo Mannelli, Danesh Alam, Antoine Douaihy, Narinder Nangia, Sarah C Akerman, Abigail Zavod, Bernard L Silverman, Maria A Sullivan

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal on addictions, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. 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

9 authors at 5 institutions in 1 country.

Sandra D ComerDepartment of Psychiatry, Columbia University Irving Medical Center, New York, New York.
Paolo MannelliDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.ORCID 0000-0002-7834-6138
Danesh AlamNorthwestern Medicine Central DuPage Hospital, Winfield, Illinois.
Antoine DouaihyDepartments of Psychiatry and Medicine, Western Psychiatric Hospital, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Narinder NangiaAlkermes, Inc., Waltham, Massachusetts.
Sarah C AkermanAlkermes, Inc., Waltham, Massachusetts.
Abigail ZavodAlkermes, Inc., Waltham, Massachusetts.
Bernard L SilvermanAlkermes, Inc., Waltham, Massachusetts.
Maria A SullivanDepartment of Psychiatry, Columbia University Irving Medical Center, New York, New York.
Alkermes (United States) · USColumbia University Irving Medical Center · USCentral DuPage Hospital · USDuke Medical Center · USUniversity of Pittsburgh · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveWhen patients seek to discontinue buprenorphine (BUP) treatment, monthly injectable extended-release naltrexone (XR-NTX) may help them avoid relapse. The efficacy of low ascending doses of oral NTX vs placebo for patients transitioning from BUP to XR-NTX is evaluated in this study.

methodsIn a phase 3, hybrid residential/outpatient study, clinically stable participants with opioid use disorder (N = 101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment, were randomized (1:1) to 7 residential days of descending doses of BUP and low ascending doses of oral NTX (NTX/BUP, n = 50) or placebo (PBO-N/BUP, n = 51). Both groups received standing ancillary medications and psychoeducational counseling. Following negative naloxone challenge, participants received XR-NTX (day 8). The primary endpoint was the proportion of participants who received and tolerated XR-NTX.

resultsThere was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407). The mean number of days with peak Clinical Opiate Withdrawal Scale (COWS) score less than or equal to 12 during the treatment period (days 1-7) was similar for NTX/BUP and PBO-N/BUP groups (5.8 vs 6.3; P = .511). Opioid withdrawal symptoms during XR-NTX induction and post-XR-NTX observation period (days 8-11) were mild and similar between groups (mean peak COWS score: NTX/BUP, 5.1 vs PBO-N/BUP, 5.4; P = .464). Adverse events were mostly mild/moderate. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Low ascending doses of oral NTX did not increase induction rates onto XR-NTX compared with placebo. The overall rate of successful induction across treatment groups supports a brief BUP taper with standing ancillary medications as a well-tolerated approach for patients seeking transition from BUP to XR-NTX. (Am J Addict 2020;00:00-00).

Indexed as

BuprenorphineDrug SubstitutionNaltrexoneAdultDelayed-Action PreparationsDose-Response Relationship, DrugDrug MonitoringFemaleHumansMaleNarcotic AntagonistsOpioid-Related DisordersSubstance Withdrawal SyndromeTreatment OutcomeBuprenorphineDelayed-Action PreparationsNaltrexoneNarcotic Antagonists

Identifiers

PMID32246728
PMCPMC7383475
OpenAlexW3014710327

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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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.