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

Completed · Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injury, Sleep Disordered Breathing

In brief

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.

Key facts

Study ID

NCT02458469

Run by

VA Office of Research and Development

People needed

15

Starts

2015-05-14

Expected to finish

2019-04-12

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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