ACTRN12612000288820
Completed
Phase 3
Optimising management of acute pain in opioid substitution therapy patients: A pilot laboratory randomised study.
Sydney Local Health District - Royal Prince Alfred Hospital0 sites21 target enrollmentStarted: March 12, 2012Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sydney Local Health District - Royal Prince Alfred Hospital
- Enrollment
- 21
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
- •(1\) patients with stable OST dose for \>4weeks (methadone and buprenorphine groups)
- •or opiate naive ie have never been dependent on opiates and have not used any opiates in the last 4 weeks (control group);
- •(2\) participants opioid substitution dose between 40\-100mg of methadone or 8\-24mg buprenorphine;
- •(3\) aged 18 – 65 yrs; and
- •(4\) participants give informed consent
Exclusion Criteria
- •(1\) severe acute medical or psychiatric conditions
- •(2\) pregnancy
- •(3\) are currently using or dependent to other substances such as alcohol, benzodiazepines, cocaine, psychostimulants or heroin;
- •(4\) moderate or severe pain within 4 weeks prior to the study
- •(5\) are currently participating in another research project that may interfere with the present study;
- •(6\) on medications with significant pharmacokinetic/dynamic interaction with study medications
- •(7\) cold urticaria
- •Eligible participants will be deemed healthy by the study physician. Participants with a current pain condition will be excluded from the study as concurrent pain conditions may confound the results from the cold pressor test, which is being used as a model for acure pain. One arm of the study involves healthy volunteers, and the other two arms of the study are a group pf patients on methadone and a group of patients on buprenorphine.
Investigators
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