Ramelteon for Complex Insomnia in Veterans With PTSD
Withdrawn before enrolling · Phase 4
Conditions studied: Insomnia
In brief
Obstructive sleep apnea is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure is the most effective therapy but adherence to treatment is suboptimal. The overarching theme of the proposal is to compare usual care to Ramelteon, in a randomized, clinical trial, investigating the effectiveness of physiological versus pharmacological intervention on sleep quality of life, insomnia severity and CPAP adherence.
Key facts
- Study ID
- NCT03265951
- Run by
- State University of New York at Buffalo
- People needed
- 0
- Starts
- 2018-01-01
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2021-04-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years and ≤70 years old
- Diagnosis of PTSD as determined by the intake conducted through the PTSD Clinic or the Mental Health Clinic
- Documented obstructive sleep apnea by polysomnography (AHI≥5 or more/hour)
- CPAP non adherence defined as less than 70% of nights with >4h CPAP use despite addressing modifiable barriers for CPAP adherence
- Psychotherapeutic treatment stable for at least 4 weeks prior to randomization
- Capable of giving informed consent
You may not qualify if…
- Medical:
- Acute or unstable chronic medical illness
- History of narcolepsy and/or cataplexy Use of any of these medications: Fluvoxamine, fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); fluoroquinolones including ciprofloxacin, levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), others; HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; rifampin
- Treatment for seizure disorders
- Pregnant or lactating
- History of clinically significant hepatic impairment
- History of hypersensitivity, intolerance, or contraindication to ramelteon
- Unwilling to try or use CPAP
- Psychiatric/Behavioral:
- Diagnosis of current schizophrenia or schizoaffective disorder
- Diagnosis of a substance dependence/abuse disorder in the past year
- Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others
- Diagnosis of bipolar disorder
- Consumption of more than two alcoholic beverages per night
- Receiving behavioral or pharmacological treatment for insomnia
Where it is running
- Veterans Affairs Medical Center in Buffalo — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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