TERMINATED

Naltrexone for Prolonged Grief Disorder

Conditions

Naltrexone HCl 50 MG Oral Tablet Placebo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-01

Study Completion:2025-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06140420

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.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

Texas Tech Health Science Center

Lubbock, Texas, 79409

United States

Collaborators and Investigators

Sponsor: Texas Tech University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2025-02-01

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

Naltrexone HCl 50 MG Oral Tablet
Placebo