Using naltrexone to treat prolonged grief disorder
Naltrexone Treatment for Prolonged Grief Disorder: A Proof of Concept Study
This study is testing if a medication called naltrexone can help people with prolonged grief disorder feel better over eight weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Texas Tech University Academic / other |
| Locations | 1 site (Lubbock, Texas) |
| Trial ID | NCT06140420 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of oral naltrexone in treating prolonged grief disorder (PGD) over an 8-week period. Participants will be randomly assigned to receive either naltrexone or a placebo, with monthly visits to monitor symptom severity, social connectedness, and any adverse reactions. The study aims to determine if naltrexone can alleviate the symptoms associated with PGD, which can significantly impact an individual's quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the diagnostic criteria for PGD and can attend clinic visits in Lubbock, Texas.
Not a fit: Patients who have recently started medications for psychiatric illnesses or those who do not meet the diagnostic criteria for PGD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from prolonged grief disorder.
How similar studies have performed: While the use of naltrexone for PGD is a novel approach, similar studies exploring pharmacological treatments for grief-related disorders have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: • Having recently started taking/prescribed medications for any psychiatric illness (e.g. SSRIs for MDD) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included. * 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.
Where this trial is running
Lubbock, Texas
- Texas Tech Health Science Center — Lubbock, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jonathan D Singer, PhD
- Email: jonsinge@ttu.edu
- Phone: 7757228066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.