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Opioid Receptor Antagonist

Naltrexone for Prolonged Grief Disorder (NPGD Trial)

Phase 4

Recruiting

Research Sponsored by Texas Tech University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 4 weeks for 8 weeks

Awards & highlights

NPGD Trial Summary

This trial studies the effectiveness of a medication to treat prolonged grief disorder (PGD). Participants monitored for 8 weeks with monthly visits.

Who is the study for?

This trial is for adults who live near NYPH, can communicate in English, and have been diagnosed with prolonged grief disorder. They must be willing to use contraception and not start any new psychiatric meds or therapy within the last 3 months. People using opioids, certain medications that affect the liver, or those with active hepatitis or abnormal liver tests cannot join.Check my eligibility

What is being tested?

The study is testing if oral naltrexone helps people with prolonged grief disorder over an 8-week period compared to a placebo. Participants will visit monthly for symptom checks and monitoring of social connections and side effects.See study design

What are the potential side effects?

Naltrexone may cause nausea, headache, dizziness, fatigue, sleep problems or anxiety. It might also lead to opioid withdrawal symptoms in those previously dependent on opioids.

NPGD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

NPGD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks for 8 weeks

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

Change in Prolonged Grief Disorder symptom severity as assessed by the PGD-12

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

NPGD Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Comparator: NaltrexoneActive Control1 Intervention

24 randomized patients will take naltrexone daily for 8 weeks

Group II: Placebo Comparator: PlaceboPlacebo Group1 Intervention

24 randomized patients will take placebo daily for 8 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Texas Tech University Health Science CenterUNKNOWN

Texas Tech UniversityLead Sponsor

81 Previous Clinical Trials

9,116 Total Patients Enrolled

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 targeting elderly people as participants?

"The current enrollment criteria for this trial requires participants to be at least 18 years old and no older than 120."

Answered by AI

Is it feasible for me to partake in the ongoing medical research?

"Potential participants must not have received a placebo and be located within the accepted age bracket (18-120) in order to qualify. This trial can accomodate up to 48 individuals."

Answered by AI

How many participants are involved in this medical experiment?

"Indeed, the clinicaltrials.gov portal conveys that this study is actively seeking patients. The experiment was first posted on August 1st 2023 and has since been updated to its current version on November 14th of the same year. This trial seeks a total of 48 people from one site."

Answered by AI

Has the U.S. Food and Drug Administration authorized Active Comparator: Naltrexone?

"The safety of Naltrexone has been firmly established with prior research, earning it a score of 3 on the scale."

Answered by AI

Are there any open slots for participants in this research endeavor?

"As per the records on clinicaltrials.gov, this study is actively recruiting for participants. It was first posted August 1st 2023 and had its latest update November 14th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Naltrexone for Prolonged Grief Disorder

Jonathan Singer 2023. "Naltrexone for Prolonged Grief Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06140420.