Prolonged Grief DisorderPhase 4PGDNCT04547985

Naltrexone Treatment for Prolonged Grief Disorder (PGD)

A Phase 4 study testing Naltrexone HCl 50 MG Oral Tablet in people with Prolonged Grief Disorder, run by Weill Medical College of Cornell University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Prolonged Grief Disorder
What is being tested?: Naltrexone HCl 50 MG Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2021to 16 Oct 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10021

Other trials in United States

About this study

Official title: Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study

Conditions: Prolonged Grief Disorder
Being tested: Naltrexone HCl 50 MG Oral Tablet, Placebo
Keywords: Naltrexone
Medical subject headings: Prolonged Grief Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Naltrexone HCl 50 MG Oral TabletDrug
Generic, oral tablet.
PlaceboDrug
Composed of filler material and encapsulated to appear identical to naltrexone.

Study groups in NCT04547985
Study group	Role	What they receive
Placebo	Placebo comparator	24 randomized patients will take placebo daily for 8 weeks. Receives: Drug: Placebo
Naltrexone	Active comparator	24 randomized patients will take naltrexone daily for 8 weeks Receives: Drug: Naltrexone HCl 50 MG Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)
Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies.
Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD.
Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
Measured: Baseline and 8 Weeks
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13
Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies.
Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD.
Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
Measured: Baseline and 12 weeks
Change in Number of Participants With Prolonged Grief Disorder 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 κ > 0.8 agreement between trainee and trainer.
Measured: Every 4 weeks for 8 weeks

Secondary outcomes (1)

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 Inclusion of Other in the Self (IOS) Scale is a self-reported pictorial tool used to measure the subjectively perceived closeness of a relationship. Respondents choose a pair of seven circles with different degrees of overlap. 1=no overlap; 2=little overlap; 3=some overlap; 4=equal overlap; 5=strong overlap; 6=very strong overlap; 7=most overlap.
The tool asks respondents to select one of seven pairs of increasingly overlapping circles that best represent 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.
Minimum Score: 1 - reflecting the least amount of overlap Maximum Score: 7 - reflecting the most amount of overlap
Measured: Every 4 weeks for 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 202116 Oct 2023

First posted14 Sep 2020
Study start5 Jan 2021
Primary completion16 Oct 2023
Study completion16 Oct 2023

Why it stopped: We are terminating the study due to low accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04547985
Sponsor's protocol ID: 20-04021873
Acronym: PGD
Status last verified: Aug 2024
First submitted: 31 Aug 2020
Last updated: 28 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 32629197
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.
PubMed 33522931

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Technology-supported Interventions for Prolonged Grief Disorder (PGD)
Prolonged Grief Disorder (PGD)
Not yet recruiting
Mechanisms Underlying Late-Life Prolonged Grief Disorder
Prolonged Grief Disorder
Active, not recruiting
Iyengar Yoga for Prolonged Grief Disorder
Prolonged Grief Disorder
Recruiting
Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder
Prolonged Grief Disorder (PGD)
Recruiting
A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department
Grief Disorder, Prolonged

All Prolonged Grief Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study
ClinicalTrials.gov ID: NCT04547985
Acronym / sponsor ID: PGD / 20-04021873
Conditions: Prolonged Grief Disorder
Keywords: Naltrexone
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: We are terminating the study due to low accrual.
Enrolment: 9 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: 5 Jan 2021 (actual)
Primary completion: 16 Oct 2023 (actual)
Study completion: 16 Oct 2023 (actual)
First posted: 14 Sep 2020 (actual)
Results: Posted 28 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo24 randomized patients will take placebo daily for 8 weeks.
Naltrexone	Active comparator	Drug: Naltrexone HCl 50 MG Oral Tablet24 randomized patients will take naltrexone daily for 8 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (10 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naltrexone HCl 50 MG Oral TabletGeneric, oral tablet.	Drug	Naltrexone
PlaceboComposed of filler material and encapsulated to appear identical to naltrexone.	Drug	Placebo

Primary outcome

Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)
Time frame: Baseline and 8 Weeks
Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13
Time frame: Baseline and 12 weeks
Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
Change in Number of Participants With Prolonged Grief Disorder 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 28 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	6
Naltrexone	3	3

Primary outcome: Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)

Time frame: Baseline and 8 Weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 4	Naltrexone n = 1
Baseline	44.75 (7.36)	39 (NA)
8 Weeks	25 (11.11)	40 (NA)

Population analysed: Four participants had dropped out of the study, and therefore, the required data for analysis was not collected.

Primary outcome: Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 4	Naltrexone n = 1
Baseline	44.75 (7.36)	39 (NA)
12 Weeks	25 (11.11)	41 (NA)

Population analysed: Four participants had dropped out of the study, and therefore, the required data for analysis was not collected.

Primary outcome: Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP)

Time frame: Every 4 weeks for 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 4	Naltrexone n = 1
4 weeks	3	1
8 weeks	1	1

Population analysed: Four participants had dropped out of the study, and therefore, the required data for analysis was not collected.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Naltrexone	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): Due to low accrual, only descriptive statistics are presented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32629197Kakarala 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.
Derived from this study: PubMed 33522931Gang 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.
Individual participant dataSharing planned: No

Related trials for Prolonged Grief Disorder

Recruiting
Technology-supported Interventions for Prolonged Grief Disorder (PGD)
Prolonged Grief Disorder (PGD)
Not yet recruiting
Mechanisms Underlying Late-Life Prolonged Grief Disorder
Prolonged Grief Disorder
Active, not recruiting
Iyengar Yoga for Prolonged Grief Disorder
Prolonged Grief Disorder
Recruiting
Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder
Prolonged Grief Disorder (PGD)
Recruiting
A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department
Grief Disorder, Prolonged

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly G Prigerson, PhD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Naltrexone HCl 50 MG Oral Tablet in people with Prolonged Grief Disorder, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13) (time frame: Baseline and 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547985, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.