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New treatment option for Sleep Initiation and Maintenance Disorders
Official title Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
ClinicalTrials.gov ID: NCT03642028
What this study is testing
What is Suvorexant?
Suvorexant is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sleep initiation and maintenance disorders.
Also referred to as Belsomra.
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
- Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease.
- 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, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide...
- Criterion A event meets DSM-5 criteria
- PTSD symptoms \>3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening
- Insomnia indicated by an ISI score \> 14
- people on non-exclusionary medications must be on a stable dose for at least 4 weeks prior to randomization, which includes the Selective Serotonin...
You likely can't join if
- DSM-5 alcohol, marijuana, and/or other drug use disorder in the last 3 months
- Mild alcohol use not meeting criteria for moderate or severe use disorder may be allowed on a case-by-case basis
- Mild or moderate marijuana use disorder may be allowed on a on a case-by-case basis
- Manic or psychotic episode in the last 5 years
- Exposure to trauma in the last 3 months
- Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS) or...
See the full eligibility criteria
- Men and Women, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide written informed consent
- Criterion A event meets DSM-5 criteria
- PTSD symptoms \>3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening
- Insomnia indicated by an ISI score \> 14
- people on non-exclusionary medications must be on a stable dose for at least 4 weeks prior to randomization, which includes the Selective Serotonin Reuptake Inhibitors (SSRIs) e.g.:
- Sertraline
- Paroxetine
- Fluoxetine
- Fluvoxamine
- Citalopram
- Escitalopram
- Serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g.:
- 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, e.g.:
- oral
- implantable
- injectable
- transdermal contraceptive
- intrauterine device
- double-barrier method
- Sleep apnea score \<30; if screening indicates mild or moderate sleep apnea (score between 5 and 30), referral will be provided
- DSM-5 alcohol, marijuana, and/or other drug use disorder in the last 3 months
- Mild alcohol use not meeting criteria for moderate or severe use disorder may be allowed on a case-by-case basis
- Mild or moderate marijuana use disorder may be allowed on a on a case-by-case basis
- Manic or psychotic episode in the last 5 years
- Exposure to trauma in the last 3 months
- 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 severe sleep apnea (score \>30) in the absence of adherence to effective treatment (such as CPAP or oral device) or positive screen for severe sleep apnea by type III device (score \> 30)
- Neurologic disorder or systemic illness affecting CNS function
- Chronic or unstable medical illness including:
- 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
- Mild cognitive impairment assessed by the Montreal Cognitive Assessment
- Pregnancy, breastfeeding and/or refusal to use effective birth control (for women)
- Narcolepsy
- Previous adverse reaction to a hypnotic
- Current use of benzodiazepines, strong CYP3A inhibitors, or Digoxin Prohibited:
- benzodiazepines
- strong CYP3A inhibitors
- Digoxin
- Furthermore, CNS depressants (e.g., benzodiazepines, opioids, alcohol) increase the risk of CNS depression when co-administered with suvorexant and will not be allowed for safety reasons.
- Since metabolism by CYP3A is the major elimination pathway for suvorexant, concomitant use of suvorexant with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone...
- All concomitant medication use will be monitored and documented
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- San Francisco, California, United States
- Salisbury, North Carolina, United States
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Long Beach, California, United States; San Francisco, California, United States; Salisbury, North Carolina, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.