Naltrexone Treatment for Prolonged Grief Disorder (PGD)
Stopped: We are terminating the study due to low accrual.
United States9 participantsStarted 2021-01-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
â. 18 years of age or older.
â. Lives within a reasonable distance from NYPH for convenient clinic visits.
â. Can speak, read, and write English proficiently.
â. Meet diagnostic criteria for PGD based on the DSM guidelines
â. 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.
â. 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
â. 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.
â. 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.
â. Prior history of recently active (e.g. within the past 3 months) opioid dependence.
â. 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).
What they're measuring
1
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)
Timeframe: Baseline and 8 Weeks
2
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13
Timeframe: Baseline and 12 weeks
3
Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP)
Timeframe: Every 4 weeks for 8 weeks
Trial details
NCT IDNCT04547985
SponsorWeill Medical College of Cornell University
â. Possible future use of opioids during the study (e.g. for surgery).
â. 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.
â. Currently pregnant, lactating, or planning to become pregnant during the study.