The effects of minocycline on breathing during sleep in patients prescribed opioid drugs for chronic pain.

Phase 2

Recruiting

• Conditions: Central sleep apnoea; chronic pain; Respiratory - Sleep apnoea; Anaesthesiology - Pain management

• Registration Number: ACTRN12613000274774
• Lead Sponsor: Repatriation General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Age 18-65 years.
-On prescribed oral long acting opioids within pre-specified dose ranges (morphine 40 – 500 mg /day, oxycodone 30 – 350mg/day or methadone 20 – 100 mg/day) .
-Central sleep apnoea index greater or equal to 5 /hr.
Chronic pain patients will only be included if they are prescribed and taking the opioid medication mentioned above, so chronic pain by itself will not be an inclusion.

Exclusion Criteria

-Clinically significant respiratory (e.g. COPD), cardiovascular (e.g. congestive cardiac failure, previous cerebro-vascular accident) or metabolic disorders.
-Major psychiatric illness.
-History of substance abuse.
-Contra-indications to minocycline use, ie. Known allergies to tetracycline, severe renal insufficiency, systemic lupus erythematosus, pregnancy or breastfeeding, concurrent prescription and non-prescription medications, vitamins, nutritional supplements, or herbal products with known interactions with tetracylines (e.g. Vitamin A/retinoids).
-Marked daytime sleepiness Epworth Sleepiness Scale (ESS) equal to or greater than 15.
-Morbid obesity BMI equal to or greater than 35 kg/m2.
-Concurrent central sleep apnoea treatment and unwilling or unable to come off treatment for in-laboratory study nights.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of patients with central apnoea index <5 /hr[3 days after starting administration of minocycline]

Secondary Outcome Measures

Name	Time	Method
analgesia effectiveness scored by Brief Pain Inventory (BPI)[3 days after starting administration of minocycline];CO2 respiratory control sensitivity during wake, using pseudorandom binary stimulation test[3 days after starting administration of minocycline]