Naltrexone for Prolonged Grief Disorder

Description

This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.

Conditions

Naltrexone HCl 50 MG Oral Tablet, Placebo

Study Overview

Study Details

Study overview

This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.

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

Naltrexone for Prolonged Grief Disorder

Condition
Naltrexone HCl 50 MG Oral Tablet
Intervention / Treatment

-

Contacts and Locations

Lubbock

Texas Tech Health Science Center, Lubbock, Texas, United States, 79409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years of age or older.
  • * Lives within a reasonable distance from NYPH for convenient clinic visits.
  • * Can speak, read, and write English proficiently.
  • * Meet diagnostic criteria for PGD based on the DSM guidelines
  • * If a female patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while she is taking the study drug. Female patients who are planning to use oral hormonal contraception during this time must have initiated it at least 2 months prior to the baseline visit.
  • * If a male patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while he is taking the study drug.
  • * Having recently started psychotherapy for any psychiatric illness within the past 3 months; participants who have been receiving psychotherapy for longer than 3 months can be included.
  • * Prior history of recently active (e.g. within the past 3 months) opioid dependence.
  • * Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including opioid antagonists for alcohol or opioid dependence, all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide).
  • * Possible future use of opioids during the study (e.g. for surgery).
  • * Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril), or any other clinically relevant medication that has potential to cause liver injury with concurrent use of naltrexone.
  • * Currently pregnant, lactating, or planning to become pregnant during the study.
  • * Active hepatitis or liver disease.
  • * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal on initial laboratory examination. Screen positive for active suicidal thoughts or behaviors.

Ages Eligible for Study

18 Years to 120 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Texas Tech University,

Study Record Dates

2025-07