Naltrexone for Prolonged Grief Disorder | NCT06140420

NCT06140420

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Texas Tech University Health Sciences Center	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo Comparator: Placebo	Placebo Comparator	24 randomized patients will take placebo daily for 8 weeks.	Drug: Placebo
Active Comparator: Naltrexone	Active Comparator	24 randomized patients will take naltrexone daily for 8 weeks	Drug: Naltrexone Oral Product

Name	Type	Description	Arm Group Labels	Other Names
Naltrexone Oral Product	Drug	Generic, oral tablet.	Active Comparator: Naltrexone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 (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.	Every 4 weeks for 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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 (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.

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Texas Tech Health Science Center		Lubbock	Texas	79409	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33522931	Background	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.
32629197	Result	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.