ACTRN12613000274774RecruitingPhase 2
A Phase IIa trial of patients on opioids for chronic pain, testing the efficacy of minocycline as a glial attenuator versus placebo on respiratory depression and analgesia.
Repatriation General Hospital0 sites15 target enrollmentStarted: March 7, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
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.
Investigators
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