A Phase 4 interventional study of Naltrexone Oral Product and Placebo in Naltrexone HCl 50 MG Oral Tablet and Placebo, sponsored by Texas Tech University. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Texas Tech University · Phase 4, Interventional, and Treatment
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.
Texas Tech University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SSRIs for MDD) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included.
24 randomized patients will take placebo daily for 8 weeks.
Drug: Placebo
24 randomized patients will take naltrexone daily for 8 weeks
Drug: Naltrexone Oral Product
Generic, oral tablet.
Oral Placebo
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.
Time frame: 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.
Time frame: Every 4 weeks for 8 weeks
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.
Time frame: Every 4 weeks for 12 weeks
Plan to share: No
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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