Naltrexone for Prolonged Grief Disorder

Placebo Clinical Trial

— NPGD  

Official title:

Naltrexone Treatment for Prolonged Grief Disorder: A Proof of Concept Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140420
• Other study ID #: TexasTechU6
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Texas Tech University
• Contact: Jonathan D Singer, PhD
• Phone: 7757228066
• Email: jonsinge[@]ttu.edu
• 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: Recruiting
• Enrollment: 48
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placebo

Intervention

Drug:
• Naltrexone Oral Product
Generic, oral tablet.
• Placebo
Oral Placebo

Locations

Country	Name	City	State
United States	Texas Tech Health Science Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	Texas Tech University Health Science Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gang J, Kocsis J, Avery J, Maciejewski PK, Prigerson HG. Naltrexone treatment for prolonged grief disorder: study protocol for a randomized, triple-blinded, placebo-controlled trial. Trials. 2021 Feb 1;22(1):110. doi: 10.1186/s13063-021-05044-8. — View Citation

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Prolonged Grief Disorder symptom severity as assessed by the PGD-12	Change in PGD symptom severity will be measured by using Prolonged Grief-13 (PGD-12), a self-rated scale consisting of 12 items. For this study, we have added an additional item inquiring about loneliness to be congruent with DSM-5-TR 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 PGD-12 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	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 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