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Orexin Receptor Antagonist
Suvorexant for Insomnia (SUV Trial)
Phase 2
Waitlist Available
Led By Scott Lane, PhD
Research Sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 21 and 65
Currently experiencing PTSD symptoms at screening as indicated by PCL-5 cut-score > 30
Must not have
Use of suvorexant within 30 days of screening
Currently on prescription medication that contraindicates use of suvorexant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (30-days prior to baseline) and baseline through day 14
Summary
"This trial aims to see if a drug called suvorexant can help reduce insomnia in 76 men and women, both veterans and non-veterans aged 21-65, who have symptoms
Who is the study for?
This trial is for men and women aged 21-65, both veterans and non-veterans, who are experiencing symptoms of PTSD along with alcohol use disorder. Participants should be willing to attempt stopping drinking for two weeks and complete daily virtual diaries as well as in-person clinic visits.
What is being tested?
The study tests if suvorexant (SUV) can help reduce insomnia in participants with PTSD and AUD. After a week on placebo, they're randomly chosen to either continue with the placebo or switch to suvorexant for another two weeks while trying to abstain from alcohol.
What are the potential side effects?
While not specified here, common side effects of suvorexant may include drowsiness, headache, dizziness, abnormal dreams or nightmares. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
Select...
I am currently experiencing strong PTSD symptoms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken suvorexant in the last 30 days.
Select...
I am taking medication that cannot be combined with suvorexant.
Select...
My liver is not working properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (30-days prior to baseline) and baseline through day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (30-days prior to baseline) and baseline through day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Insomnia Severity Index (ISI) score from baseline to Day 14.
Secondary study objectives
Change in PTSD score as measured by the PTSD Checklist for DSM-5 (PCL-5) from baseline to Day 14.
Change in PTSD total symptom severity score as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to Day 14.
Change in cue-induced alcohol craving, as assessed by the Alcohol Urge Questionnaire (AUQ) during the alcohol condition, from baseline to day 14.
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: 10mg and 20mg Suvorexant (SUV)Active Control1 Intervention
Participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)).
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomly assigned to receive matched placebo (Days 0-13).
Find a Location
Who is running the clinical trial?
University of California, Los AngelesOTHER
1,569 Previous Clinical Trials
10,314,213 Total Patients Enrolled
20 Trials studying Alcoholism
4,253 Patients Enrolled for Alcoholism
The University of Texas Health Science Center, HoustonOTHER
957 Previous Clinical Trials
347,776 Total Patients Enrolled
8 Trials studying Alcoholism
7,914 Patients Enrolled for Alcoholism
Pharmacotherapies for Alcohol and Substance Use Disorders AllianceLead Sponsor
8 Previous Clinical Trials
269 Total Patients Enrolled
7 Trials studying Alcoholism
149 Patients Enrolled for Alcoholism
Scott Lane, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Lara Ray, PhDPrincipal InvestigatorUniversity of California, Los Angeles
7 Previous Clinical Trials
360 Total Patients Enrolled
7 Trials studying Alcoholism
360 Patients Enrolled for Alcoholism