Ramelteon for Complex Insomnia in Veterans With PTSD

• Status: Withdrawn
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Collaborator: The VA Western New York Healthcare System

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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