Naltrexone Treatment for Prolonged Grief Disorder (PGD) (PGD)
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|ClinicalTrials.gov Identifier: NCT04547985|
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : December 27, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Prolonged Grief Disorder||Drug: Naltrexone HCl 50 MG Oral Tablet Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study|
|Actual Study Start Date :||January 5, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||January 2024|
Placebo Comparator: Placebo
24 randomized patients will take placebo daily for 8 weeks.
Composed of filler material and encapsulated to appear identical to naltrexone.
Active Comparator: Naltrexone
24 randomized patients will take naltrexone daily for 8 weeks
Drug: Naltrexone HCl 50 MG Oral Tablet
Generic, oral tablet.
- Change in Prolonged Grief Disorder symptom severity as assessed by Prolonged Grief-13 (PG-13) [ Time Frame: Weekly for 12 weeks. ]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.
- Change in Prolonged Grief Disorder severity as assessed by Structured Clinical Interview for PGD (SCIP) [ Time Frame: 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 strength of subjectively perceived closeness of a social relationship as measured by the Inclusion of the other in the Self (IOS) Scale [ Time Frame: Every 4 weeks for 12 weeks ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547985
|Contact: Francesco Ossofirstname.lastname@example.org|
|Contact: Hillary Winokeremail@example.com|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10021|
|Contact: Holly G Prigerson, PhD 617-459-3304 firstname.lastname@example.org|
|Principal Investigator:||Holly G Prigerson, PhD||Weill Medical College of Cornell University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Weill Medical College of Cornell University|
|Other Study ID Numbers:||
5R35CA197730-05 ( U.S. NIH Grant/Contract )
|First Posted:||September 14, 2020 Key Record Dates|
|Last Update Posted:||December 27, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents