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

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury; Sleep Disordered Breathing

Intervention: Buspirone (Drug); Trazodone (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Abdulghani Sankari, PhD, Principal Investigator, Affiliation: John D. Dingell VA Medical Center, Detroit, MI

Overall contact:
Abdulghani Sankari, PhD, Phone: (313) 576-1000, Ext: 63499, Email: Abdulghani.Sankari@va.gov

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.

Clinical Details

Official title: Pathogenesis of Sleep Disordered Breathing in Spinal Cord Injury Patients

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: CO2 reserve (Delta-PETCO2-AT)

Secondary outcome: AHI (apnea/hypopnea index)

Detailed description: Randomized placebo controlled cross-over study. Each subject will be studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; the patients will be blinded to whether they are taking trazodone or placebo; buspirone cannot be blinded because it is dosed twice a day and is up titrated during the two weeks of administration. The initial dose of Buspirone is 15 mg daily (7. 5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached. After the two week treatment a sleep study will be repeated. Trazodone will be given at 100 mg dose before bed-time. (2) Cross over medication for two weeks will be followed by a second sleep study followed by two weeks washout. (3) Cross over medication for two weeks will be followed by another sleep study. To assess the clinical effect of the drug on breathing during sleep a qualitative polysomnography will be performed for 2 hours the same night after taking the drug/placebo. This will allow the determination of ventilatory changes and the determination of the number of respiratory events (apnea/hypopnea index).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnant and lactating females

- Demyelinating SCI

- Heart failure, vascular disease, or stroke

- History of head trauma ->loss of consciousness >24h

- Advanced COPD, liver disease, and chronic kidney disease

- BMI >38 kg/m2

- Blood pressure at rest > 160 /95 mmHg

- 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

- MAO inhibitors [such as Marplan, Nardil, Parmate, Emsam]

- Other prohibited concomitant medications include haloperidol, trazodone, or

triazolam

Locations and Contacts

Abdulghani Sankari, PhD, Phone: (313) 576-1000, Ext: 63499, Email: Abdulghani.Sankari@va.gov

John D. Dingell VA Medical Center, Detroit, MI, Detroit, Michigan 48201, United States; Recruiting
Abdulghani Sankari, PhD, Phone: 313-576-1000, Ext: 63499, Email: Abdulghani.Sankari@va.gov
M S Badr, MD, Phone: (313) 374-2038, Email: sbadr@med.wayne.edu
Abdulghani Sankari, PhD, Principal Investigator
Additional Information

Starting date: May 2015
Last updated: May 27, 2015

Page last updated: August 23, 2015

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