- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547985
Naltrexone Treatment for Prolonged Grief Disorder (PGD) (PGD)
October 20, 2023 updated by: Weill Medical College of Cornell University
Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hillary Winoker
- Phone Number: 646-962-7143
- Email: hiw4002@med.cornell.edu
Study Contact Backup
- Name: Francesco Osso
- Phone Number: 929-578-0305
- Email: fro4001@med.cornell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Generic, oral tablet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Weekly for 12 weeks.
|
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.
|
Every 4 weeks for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
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
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.
|
Every 4 weeks for 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Holly G Prigerson, PhD, Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2021
Primary Completion (Actual)
October 16, 2023
Study Completion (Actual)
October 16, 2023
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
September 11, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 20, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-04021873
- 5R35CA197730-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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