Insomnia study: Suvorexant
Official title The Effects of Orexin Antagonism on Fear Extinction in PTSD
ClinicalTrials.gov ID: NCT06788522
What this study is testing
What is Suvorexant?
Suvorexant is an investigational medicine, taken by mouth, being studied as a potential treatment for insomnia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether suvorexant, a medicine that blocks orexin, helps fear extinction in veterans with PTSD and insomnia.
- Who it's for
- You may be able to join if you are a veteran with PTSD and trouble sleeping.
- What's involved
- You will take suvorexant pills each night. You will come to the clinic for a few visits where they will check your sleep and fear responses.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- men and women
- a history of US military service
- capable of reading and understanding English
- able to provide written informed consent
- Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma
You likely can't join if
- Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months
- Mild alcohol use disorder with abstinence of 30 days will be allowed
- Mild marijuana use disorder will be allowed with abstinence for one week prior to participation
- Any other DSM-5 drug use disorder in the last 3 months will be excluded
- Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with...
- Exposure to trauma in the last 3 months
See the full eligibility criteria
- men and women
- a history of US military service
- capable of reading and understanding English
- able to provide written informed consent
- Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma
- Chronic full PTSD diagnosis \>3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score \> 30
- Insomnia indicated by insomnia severity index (ISI) score \> 14
- sertraline
- paroxetine
- fluoxetine
- fluvoxamine
- citalopram
- escitalopram
- Desvenlafaxine
- Duloxetine
- Levomilnacipran
- Venlafaxine
- For people who are in psychotherapy, treatment must be stable for 6 weeks
- Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control
- Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months
- Mild alcohol use disorder with abstinence of 30 days will be allowed
- Mild marijuana use disorder will be allowed with abstinence for one week prior to participation
- Any other DSM-5 drug use disorder in the last 3 months will be excluded
- Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features
- Exposure to trauma in the last 3 months
- Use of exclusionary antidepressant (trazodone, mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication
- Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS) or increased risk of suicide that necessitates additional therapy or...
- Pre-existing moderate sleep apnea or positive screen for sleep apnea by type III device (AHI\>15) in the absence of adherence to effective treatment (such as CPAP or oral device)
- Night shift work or extreme morning or evening tendencies in order to avoid the impact of circadian factors on subjective and objective sleep measures
- Neurologic disorder or systemic illness affecting CNS function
- unstable angina
- myocardial infarction within the past 6 months
- congestive heart failure
- preexisting hypotension or orthostatic hypotension
- heart block or arrhythmia
- chronic renal or hepatic failure
- pancreatitis
- severe chronic obstructive pulmonary disease
- History of severe traumatic brain injury as assessed by the Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI ID)
- Uncorrected hearing impairment
- Mild cognitive impairment assessed by the Montreal Cognitive Assessment (MOCA)
- Pregnancy, breastfeeding and/or refusal to use effective birth control (for women)
- Previous adverse reaction to a hypnotic
- Current use of benzodiazepines, strong inhibitors of CYP3A, or Digoxin
- The investigators will require that all participants do not consume heavy amounts of alcohol per week (\>7 drinks for women, \>14 drinks for men) or use illicit drugs for one week prior to participation
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.