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

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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000274774

Enrollment

Registered

2013-03-07

Start date

2013-03-12

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to find a new way of treating central sleep apnoea and drug tolerance caused by opioid medication prescribed for chronic pain. The medication tested in this study is Minocycline, a commonly used antibiotic with effects on the central nervous system's immune system. Hypothesis Minocycline will reduce the severity of central sleep apnoea in patients prescribed opioids for chronic pain. Minocycline will increase the analgesic efficacy of opioids prescribed to chronic pain patients.

Interventions

Minocycline hydrochloride, 100 mg will be administered orally, twice daily for 3 days. A washout period of at least 1 week will follow. The study is randomised so the washout is between placebo then minocycline, or minocycline then placebo. the study is double-blinded, so only the statistician in this study will know.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results