Naltrexone Treatment for Prolonged Grief Disorder (PGD)

Phase 4

Terminated

Conditions: Prolonged Grief Disorder

Interventions: Drug: Naltrexone HCl 50 MG Oral Tablet
Drug: Placebo

Registration Number: NCT04547985

Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone	Naltrexone HCl 50 MG Oral Tablet	24 randomized patients will take naltrexone daily for 8 weeks
Placebo	Placebo	24 randomized patients will take placebo daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)	Baseline and 8 Weeks	Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP)	Every 4 weeks for 8 weeks	Eligibility for the study and change in symptom severity will be measured by SCIP. This structured clinical interview is adapted to the DSM-5-TR criteria for PGD. Interviewers will be trained to standard which will be a κ \> 0.8 agreement between trainee and trainer.
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13	Baseline and 12 weeks	Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Strength of Subjectively Perceived Closeness of a Social Relationship as Measured by the Inclusion of the Other in the Self (IOS) Scale	Every 4 weeks for 12 weeks	The Inclusion of Other in the Self (IOS) Scale is a self-reported pictorial tool used to measure the subjectively perceived closeness of a relationship. Respondents choose a pair of seven circles with different degrees of overlap. 1=no overlap; 2=little overlap; 3=some overlap; 4=equal overlap; 5=strong overlap; 6=very strong overlap; 7=most overlap. The tool asks respondents to select one of seven pairs of increasingly overlapping circles that best represent their relationship with another, with more overlap signifying a closer relationship. This scale possesses good reliability, with (α=.93) for the entire sample, (α=.87) for family, (α=.92) for friendship, and (α=.95) for romantic relationships. Test-retest reliability shows similar findings, with (α=.83) for the entire sample, (α=.85) for family, (α=.86) for friendship, and (α=.85) for romantic relationships. Minimum Score: 1 - reflecting the least amount of overlap Maximum Score: 7 - reflecting the most amount of overlap