Evidence map›Paper›PMID 33522931›Full record

ArticleTrials2021

Naltrexone treatment for prolonged grief disorder: study protocol for a randomized, triple-blinded, placebo-controlled trial.

James Gang, James Kocsis, Jonathan Avery, Paul K Maciejewski, Holly G Prigerson

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
4.2field-weighted citation impact, top 6% 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.

NCT04547985 phase4terminatednot on this map

Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study

TypeinterventionalSponsorWeill Medical College of Cornell UniversityRan2021 to 2023Enrolled9ConditionsProlonged Grief DisorderArmsNaltrexone HCl 50 MG Oral Tablet, Placebo
NCT06140420 phase4terminatednot on this mapstarted 2023, after this paper: background citation

Naltrexone Treatment for Prolonged Grief Disorder: A Proof of Concept Study

TypeinterventionalSponsorTexas Tech UniversityRan2023 to 2025Enrolled7ConditionsNaltrexone HCl 50 MG Oral Tablet, PlaceboArmsNaltrexone Oral Product, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 37 citations in OpenAlex.

  1. Prolonged grief disorder in later life: advancing our understanding of biopsychosocial mechanisms to guide future personalized interventions.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026
    Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Prolonged Grief Disorder: Unveiling Neurobiological Mechanisms for a Shared Path Forward.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2024
    Article
  7. Prolonged grief disorder in ICD-11 andThe Australian and New Zealand journal of psychiatry · 2023
    Review
  8. 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

5 authors at 1 institution in 1 country.

James GangCenter for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.
James KocsisDepartment of Psychiatry, Weill Cornell Medicine, New York, NY, USA.
Jonathan AveryDepartment of Psychiatry, Weill Cornell Medicine, New York, NY, USA.
Paul K MaciejewskiCenter for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.
Holly G PrigersonCenter for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA. hgp2001@med.cornell.edu.ORCID http://orcid.org/0000-0002-7075-4268
Cornell University · US

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Psychosocial Approaches to Better Understanding & End-Stage Cancer Care (PROTECT)R35CA197730 · NCI · WEILL MEDICAL COLL OF CORNELL UNIV · PI Holly Gwen Prigerson · 2015 to 2026
$11.2M
NCATS NIH HHS TR002384NCATS NIH HHS UL1 TR002384NCI NIH HHS R35 CA197730NIH HHS 5R35CA197730-05
6 · The paper itself

Abstract

backgroundThere is a lack of effective pharmacotherapy for prolonged grief disorder (PGD). Evidence suggests that the neurobiology of PGD involves the same circuitry as the reward pathway. Based upon this evidence, we hypothesize that PGD can be conceptualized as a disorder of addiction and therefore could benefit from being treated with medications that are currently used to treat such disorders. One such medication is naltrexone, which is currently used to treat alcohol and opioid dependence. Oral naltrexone was chosen for its mechanism of action, safety, and convenience. The primary aim of this study is to establish the efficacy of using oral naltrexone as a pharmacological treatment for PGD. Specifically, we hypothesize that participants receiving naltrexone will demonstrate reduced PGD symptoms when compared to placebo. METHODS/

designThis is a randomized, placebo-controlled, triple-blinded (to healthcare professionals/study staff, participants, and data analysts) study in which we propose to enroll 48 participants who meet criteria for Prolonged Grief Disorder (PGD). Participants will be randomly assigned to the naltrexone 50 mg oral arm or placebo arm; medications will be over-encapsulated to appear identical. Participants will take their assigned medication for 8 weeks, with clinic visits every 4 weeks to assess symptom severity, social closeness, and adverse reactions. Weekly surveys of Prolonged Grief-13-Revised (PG-13-R) will be used to relate naltrexone use to changes in PGD symptom severity. Follow-up 4 weeks after their last visit will assess the longevity of treatment, as well as any lingering adverse reactions. DISCUSSION: This study is the first to investigate the use of oral naltrexone as pharmacological treatment for PGD. The acute and debilitating nature of the disorder, in addition to the increased risk of comorbidities, highlights the need for pharmacological treatment like naltrexone that can act more rapidly, may help those for whom psychotherapy may not be effective, and/or may augment psychotherapy to promote PGD symptom grief resolution.

trial registrationClinicalTrials.gov NCT04547985 . Registered on 8/31/2020.

Indexed as

NaltrexoneOpioid-Related DisordersComorbidityGriefHumansRandomized Controlled Trials as TopicResearch DesignNaltrexoneNaltrexonePharmacological treatmentProlonged grief disorderRandomized control trial

Identifiers

PMID33522931
PMCPMC7848251
OpenAlexW3114869761

What OpenQuestion holds

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LicenceCC BY
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.