Naltrexone HCl 50 MG Oral TabletPhase 4NPGDNCT06140420

Naltrexone for Prolonged Grief Disorder

A Phase 4 study testing Naltrexone Oral Product in people with Naltrexone HCl 50 MG Oral Tablet and Placebo, run by Texas Tech University at 1 site in United States.

Terminated

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

Official record

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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 to 120 yearsHealthy volunteers can take part
Conditions the study is for: Naltrexone HCl 50 MG Oral Tablet, Placebo
What is being tested?: Naltrexone Oral Product
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2023to 1 Feb 2025
Phase: Phase 4
Are there results?: None posted in the registry

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 to 120 years
All sexes
Healthy volunteers accepted
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).

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Tech Health Science Center
Lubbock, Texas, 79409

Other trials in United States

About this study

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

Conditions: Naltrexone HCl 50 MG Oral Tablet, Placebo
Being tested: Naltrexone Oral Product, Placebo

What participants receive

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

Naltrexone Oral ProductDrug
Generic, oral tablet.
PlaceboDrug
Oral Placebo

Study groups in NCT06140420
Study group	Role	What they receive
Placebo Comparator: Placebo	Placebo comparator	24 randomized patients will take placebo daily for 8 weeks. Receives: Drug: Placebo
Active Comparator: Naltrexone	Active comparator	24 randomized patients will take naltrexone daily for 8 weeks Receives: Drug: Naltrexone Oral Product

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 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.
Measured: 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.
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 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.
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.

1 Aug 20231 Feb 2025

First posted20 Nov 2023
Study start1 Aug 2023
Primary completion1 Feb 2025
Study completion1 Feb 2025

Why it stopped: Funding unexpectedly withdrawn

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Naltrexone HCl 50 MG Oral TabletStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06140420
Sponsor's protocol ID: TexasTechU6
Acronym: NPGD
Status last verified: May 2026
First submitted: 14 Nov 2023
Last updated: 18 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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
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

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Naltrexone Treatment for Prolonged Grief Disorder: A Proof of Concept Study
ClinicalTrials.gov ID: NCT06140420
Acronym / sponsor ID: NPGD / TexasTechU6
Conditions: Naltrexone HCl 50 MG Oral Tablet, Placebo
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding unexpectedly withdrawn
Enrolment: 7 participants (actual)
Lead sponsor: Texas Tech UniversityUniversity, hospital or other
Collaborators: Texas Tech University Health Sciences Center
Study start: 1 Aug 2023 (actual)
Primary completion: 1 Feb 2025 (actual)
Study completion: 1 Feb 2025 (actual)
First posted: 20 Nov 2023 (actual)
Results: Not posted in the source record

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Comparator: Placebo	Placebo comparator	Drug: Placebo24 randomized patients will take placebo daily for 8 weeks.
Active Comparator: Naltrexone	Active comparator	Drug: Naltrexone Oral Product24 randomized patients will take naltrexone daily for 8 weeks

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: 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).

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 Oral ProductGeneric, oral tablet.	Drug	Active Comparator: Naltrexone
PlaceboOral Placebo	Drug	Placebo Comparator: Placebo

Primary outcome

Change in Prolonged Grief Disorder symptom severity as assessed by the PGD-12
Time frame: Weekly for 12 weeks
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.
Change in Prolonged Grief Disorder severity as assessed by Structured Clinical Interview for PGD
Time frame: Every 4 weeks for 8 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.

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

The study was stopped early (reason given: Funding unexpectedly withdrawn). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Background: 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.
Results publication: 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.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Oral Product in people with Naltrexone HCl 50 MG Oral Tablet and Placebo, run by Texas Tech 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 18 May 2026. 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?

The study was stopped early (reason given: Funding unexpectedly withdrawn). Results are not available in the source record.

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 the PGD-12 (time frame: Weekly for 12 weeks). The study lists 2 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 NCT06140420, 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 18 May 2026.