Status:
WITHDRAWN
Ramelteon for Complex Insomnia in Veterans With PTSD
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
The VA Western New York Healthcare System
Conditions:
Insomnia
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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. Continuou...
Detailed Description
Despite the overall improvement in PTSD symptomatology with CPAP therapy, adherence to CPAP is far worse in Veterans with PTSD (41%) compared to the general population with OSA (70%). Among the factor...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03265951
Start Date
January 1 2018
End Date
June 30 2020
Last Update
April 9 2021
Active Locations (1)
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1
Veterans Affairs Medical Center in Buffalo
Buffalo, New York, United States, 14215