Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

• Status: Completed
• Trial end date: 2019-04-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Buspirone; Trazodone

Criteria

Inclusion Criteria:

• Adults with SCI (>6months after spinal cord injury) at the T6 level/above

Exclusion Criteria:

• Pregnant and lactating females

• Heart failure, vascular disease, or stroke

• Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease

• BMI >38 kg/m2

• Mechanical ventilation dependence

• The following medications are not allowed (potential interaction with buspirone or inhibition of the CYP3A4 system):

• cimetidine

• ketoconazole

• ritonavir

• itraconazole

• erythromycin

• diltiazem

• verapamil

• Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]

• Other prohibited concomitant medications include haloperidol, trazodone, or triazolam