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Clinical Trials/ACTRN12613000274774
ACTRN12613000274774
Recruiting
Phase 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 enrollmentMarch 7, 2013
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ConditionsCentral sleep apnoeachronic painRespiratory - Sleep apnoeaAnaesthesiology - Pain management

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Central sleep apnoea
Sponsor
Repatriation General Hospital
Enrollment
15
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 7, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Repatriation General Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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