Naltrexone for Prolonged Grief Disorder (NCT06140420) | Clinical Trial Compass
TerminatedPhase 4
Naltrexone for Prolonged Grief Disorder
Stopped: Funding unexpectedly withdrawn
United States7 participantsStarted 2023-08-01
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 – 120 Years
SexALL
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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 dependen…
What they're measuring
1
Change in Prolonged Grief Disorder symptom severity as assessed by the PGD-12
Timeframe: Weekly for 12 weeks
2
Change in Prolonged Grief Disorder severity as assessed by Structured Clinical Interview for PGD