Optimising Management of acute pain in Opioid Substitution Therapy patients: A pilot laboratory randomised study

Phase 3

Completed

• Conditions: Acute pain in opioid dependence; Mental Health - Addiction; Anaesthesiology - Pain management

• Registration Number: ACTRN12612000288820
• Lead Sponsor: Sydney Local Health District - Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-12
• Study Completion: 2017-08-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain threshold and tolerance using a cold pressor model of pain[Cold pressor intervention occurs at 2h post baseline. Methadone or buprenorphine (+/- naloxone) administration occurs at baseline. Gabapentin is administered at t = 60 min. Oxycodone is administered at t = 90 min.]