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Evaluating Naltrexone's Efficacy in Reducing Symptom Severity of Patients with Prolonged Grief Disorder

Evaluating Naltrexone's Efficacy in Reducing Symptom Severity of Patients with Prolonged Grief Disorder in Zahedan in 2025: A Randomized, Triple-Blinded, Placebo-Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250611066174N1
Enrollment
50
Registered
2025-06-20
Start date
2025-07-16
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged grief disorder. Other reactions to severe stress

Interventions

Intervention 1: Intervention group: Intervention group: Naltrexone 50 mg (Al-Hawi Pharmaceutical [Iran]) will be administered daily for 8 weeks, starting the day after the first clinic visit, packaged

Sponsors

Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Meeting diagnostic criteria for PGD based on/in accordance with DSM criteria, which include: Death of a person who is dearer to the survivor than others Since the death, the person has had a grief reaction or a preoccupation with the deceased person, ruminating on their memories almost every day for the past month. As a result of the death of a loved one, experience at least 3 of the following symptoms nearly every day, for at least the past month: a) Identity disintegration (e.g., feeling that part of oneself has died); b) Feelings of marked disbelief about the death of the deceased; avoidance of reminders of the deceased; and intense emotional pain (e.g., anger, bitterness, sadness); c) Difficulty moving on with life (e.g., problems interacting with friends, pursuing interests, planning for the future); d) Emotional numbness; f) Feeling that my life is meaningless; and d) Intense loneliness (i.e., feeling alone or disconnected from others). If the patient is female, agree to use contraception and be willing and able to continue using contraception for the first 8 weeks of the study while taking naltrexone.

Exclusion criteria

Exclusion criteria: Taking psychiatric medications (such as SSRIs for MDD) Have received psychotherapy for mental illness in the past 3 months (participants who have received psychotherapy for more than 3 months can be included in the study) History of dependence on opioids or illicit drugs, alcohol or opioid antagonists, all opioid pain medications, certain cough and cold medications (e.g., codeine), and some antidiarrheal medications (e.g., loperamide). Possible use of opioids during the study (e.g., for surgery). 6. Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril), or any clinically relevant drug that has the potential to cause liver injury when taken concomitantly with naltrexone. Pregnancy or breastfeeding Active hepatitis or liver disease. Also. Increased ALT/AST > 5 and for kidney patients, decreased GFR below 30 mL/min. Having suicidal thoughts

Design outcomes

Primary

MeasureTime frame
Prolonged grief disorder symptoms. Timepoint: Weeks 1, 4, and 8 after intervention. Method of measurement: Standard Prolonged Grief Disorder Questionnaire PGD-13-R-Scale.;Cognitive flexibility. Timepoint: Weeks 1, 4, and 8 after intervention. Method of measurement: Standard Cognitive Flexibility Questionnaire (CFI) by Dennis and Vanderwaal.;Eagerness to communicate. Timepoint: Weeks 1, 4, and 8 after intervention. Method of measurement: WTC Communication Scale.;Suicidal tendencies. Timepoint: Weeks 1, 4, and 8 after intervention. Method of measurement: IPTS Suicidality Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Zohreh Sargazifar

Zahedan University of Medical Sciences

zohreh.ss1404@zaums.ac.ir+98 54 3329 5725

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026