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Opioid Receptor Antagonist
Naltrexone for Prolonged Grief Disorder (NPGD Trial)
Phase 4
Recruiting
Research Sponsored by Texas Tech University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Must not have
Active hepatitis or liver disease
Current prescription, non-prescription, or illicit opioid use, 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks for 8 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial studies the effectiveness of a medication to treat prolonged grief disorder (PGD). Participants monitored for 8 weeks with monthly visits.
Who is the study for?
This trial is for adults who live near NYPH, can communicate in English, and have been diagnosed with prolonged grief disorder. They must be willing to use contraception and not start any new psychiatric meds or therapy within the last 3 months. People using opioids, certain medications that affect the liver, or those with active hepatitis or abnormal liver tests cannot join.
What is being tested?
The study is testing if oral naltrexone helps people with prolonged grief disorder over an 8-week period compared to a placebo. Participants will visit monthly for symptom checks and monitoring of social connections and side effects.
What are the potential side effects?
Naltrexone may cause nausea, headache, dizziness, fatigue, sleep problems or anxiety. It might also lead to opioid withdrawal symptoms in those previously dependent on opioids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active hepatitis or another liver disease.
Select...
I am currently using opioids, including for cough, cold, or diarrhea.
Select...
I am not taking medications like Arava, Droleptan, Valium, or Mellaril that could harm my liver with naltrexone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 weeks for 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks for 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Prolonged Grief Disorder severity as assessed by Structured Clinical Interview for PGD
Change in Prolonged Grief Disorder symptom severity as assessed by the PGD-12
Secondary study objectives
Change in strength of subjectively perceived closeness of a social relationship as measured by the Inclusion of the other in the Self (IOS) Scale
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Comparator: NaltrexoneActive Control1 Intervention
24 randomized patients will take naltrexone daily for 8 weeks
Group II: Placebo Comparator: PlaceboPlacebo Group1 Intervention
24 randomized patients will take placebo daily for 8 weeks.
Find a Location
Who is running the clinical trial?
Texas Tech University Health Science CenterUNKNOWN
Texas Tech UniversityLead Sponsor
82 Previous Clinical Trials
9,231 Total Patients Enrolled