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Opioid Antagonist

Naltrexone for Prolonged Grief Disorder (PGD Trial)

Phase 4
Waitlist Available
Led By Holly G Prigerson, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks for 8 weeks
Awards & highlights

PGD Trial Summary

This trial is testing whether oral naltrexone helps people with prolonged grief disorder. People will take the medication for 8 weeks and have monthly check-ins to see how they're doing.

Eligible Conditions
  • Prolonged Grief Disorder
  • Preimplantation Genetic Diagnosis

PGD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks for 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks for 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Prolonged Grief Disorder severity as assessed by Structured Clinical Interview for PGD (SCIP)
Change in Prolonged Grief Disorder symptom severity as assessed by Prolonged Grief-13 (PG-13)
Secondary outcome measures
Change in strength of subjectively perceived closeness of a social relationship as measured by the Inclusion of the other in the Self (IOS) Scale

PGD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: NaltrexoneActive Control1 Intervention
24 randomized patients will take naltrexone daily for 8 weeks
Group II: PlaceboPlacebo Group1 Intervention
24 randomized patients will take placebo daily for 8 weeks.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,310 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,263 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,300 Total Patients Enrolled

Media Library

Naltrexone HCl 50 MG Oral Tablet (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04547985 — Phase 4
Prolonged Grief Disorder Research Study Groups: Placebo, Naltrexone
Prolonged Grief Disorder Clinical Trial 2023: Naltrexone HCl 50 MG Oral Tablet Highlights & Side Effects. Trial Name: NCT04547985 — Phase 4
Naltrexone HCl 50 MG Oral Tablet (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04547985 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor admitting new participants at the moment?

"Affirmative. Clinicaltrials.gov has documented the availability of this medical trial, which was originally posted on May 1st 2021 and updated most recently in November 18th 2022. 48 patients from one centre need to be enrolled for participation."

Answered by AI

Is Naltrexone being tested in other research studies?

"Presently, there are 46 active clinical trials investigating Naltrexone with 12 of those being in the third stage. These experiments span a total of 161 locations, particularly concentrated around New york City."

Answered by AI

What is the maximum capacity allowed for participation in this research project?

"Affirmative. This clinical trial, initially posted on May 1st 2021, is still actively recruiting candidates according to data hosted on clinicaltrials.gov. The medical study requires 48 patients from a single site."

Answered by AI

What medical conditions commonly necessitate the utilization of Naltrexone?

"Naltrexone has been approved for use in long-term weight management, increased physical activity, and the alleviation of chronic pain."

Answered by AI

Has the United States Food and Drug Administration (FDA) authorized Naltrexone for use?

"There is a wealth of evidence affirming Naltrexone's safety, thus it receives a stellar score of 3."

Answered by AI
~2 spots leftby Apr 2025