Naltrexone Treatment for Prolonged Grief Disorder (PGD)

Prolonged Grief Disorder Clinical Trial

— PGD  

Official title:

Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04547985
• Other study ID #: 20-04021873
• Status: Terminated
• Phase: Phase 4
• Start date: January 5, 2021
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older.

2. Lives within a reasonable distance from NYPH for convenient clinic visits.

3. Can speak, read, and write English proficiently.

4. Meet diagnostic criteria for PGD based on the DSM guidelines

5. 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.

6. 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:

1. 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.

2. 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.

3. Prior history of recently active (e.g. within the past 3 months) opioid dependence.

4. 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).

5. Possible future use of opioids during the study (e.g. for surgery).

6. 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.

7. Currently pregnant, lactating, or planning to become pregnant during the study.

8. Active hepatitis or liver disease.

9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal on initial laboratory examination.

10. Screen positive for active suicidal thoughts or behaviors.

Related Conditions & MeSH terms

• Prolonged Grief Disorder

Intervention

Drug:
• Naltrexone HCl 50 MG Oral Tablet
Generic, oral tablet.
• Placebo
Composed of filler material and encapsulated to appear identical to naltrexone.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kakarala SE, Roberts KE, Rogers M, Coats T, Falzarano F, Gang J, Chilov M, Avery J, Maciejewski PK, Lichtenthal WG, Prigerson HG. The neurobiological reward system in Prolonged Grief Disorder (PGD): A systematic review. Psychiatry Res Neuroimaging. 2020 Sep 30;303:111135. doi: 10.1016/j.pscychresns.2020.111135. Epub 2020 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Prolonged Grief Disorder symptom severity as assessed by Prolonged Grief-13 (PG-13)	Change in PGD symptom severity will be measured by using Prolonged Grief-13 (PG-13), a self-rated scale consisting of 11 items. For this study, we have added an additional item inquiring about loneliness to be congruent with DSM criteria and SCIP. This 5-point Likert-type of measurement tool evaluates the intensity and severity of the PGD. The validity and reliability of the PG-13 was tested and validated in previous studies.	Weekly for 12 weeks.
Primary	Change in Prolonged Grief Disorder severity as assessed by Structured Clinical Interview for PGD (SCIP)	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 ? > 0.8 agreement between trainee and trainer.	Every 4 weeks for 8 weeks
Secondary	Change in strength of subjectively perceived closeness of a social relationship as measured by the Inclusion of the other in the Self (IOS) Scale	The IOS is a self-reported pictorial tool use to measure the subjectively perceived closeness of a relationship. The tool asks respondents to select one of seven pairs of increasingly overlapping circles that best represents their relationship with another, with more overlap signifying a closer relationship. This scale possesses good reliability, with (a = .93) for the entire sample, (a = .87) for family, (a = .92) for friendship, and (a = .95) for romantic relationships. Test-retest reliability shows similar findings, with (a = .83) for the entire sample, (a = .85) for family, (a = .86) for friendship, and (a = .85) for romantic relationships.	Every 4 weeks for 12 weeks