A pilot study examining the analgesic effect of ascending buprenorphine doses in opioid dependent people

Phase 4

Completed

• Conditions: Pain; Opioid dependence; Anaesthesiology - Pain management; Mental Health - Addiction

• Registration Number: ACTRN12614001038684
• Lead Sponsor: South Eastern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-25
• Study Completion: 2018-05-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1.Being at least 18 - 60 years of age
2.Being of general good medical and psychiatric health
3.Female participants must not be pregnant or nursing, and must have agreed to use an acceptable method of birth control.
4.Be stable buprenorphine treatment, including being on a stable dose of buprenorphine (4-16mg/day) at least 10 days.
5.Be willing to and capable of signing an informed consent.
6.Primary language spoken is English

Exclusion Criteria

Potential participants must not:
1.Be dependent on alcohol, benzodiazepines, cannabis or other drugs of abuse that require immediate medical attention or be unsafe in the context of the study.
2.Be actively involved in another clinical trial.
3.Have a physiological, neurological or psychiatric illness (e.g. schizophrenia, Raynaud’s disease, urticaria, stroke) that would affect pain responses.
4.Be currently taking analgesic medication for a painful condition on a regular basis.
5.Be currently taking a medication known to affect pain response (e.g. antidepressants)
6.Be taking medications, herbal or vitamin supplements or other dietary supplements (eg grapefruit juice) that may interfere with the metabolism of the study medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain threshold (time with arm in the cold pressor bath until participant reports pain detection)[2 hours following buprenorphine dose];Pain tolerance (total time with arm in the cold pressor bath until participant removes their arm)[2 hours after buprenorphine dose]

Secondary Outcome Measures

Name	Time	Method
Respiration (breaths per minute) observation visually[Baseline, 1h 50min, 2h 10min ];Subjective effects of medication on 0 - 100mm Visual Analog Scale. Items measured on the scale include strength of drug effect, liking of drug effect, sedation, bad effects and intoxication. These measures are commonly assessed in drug administration studies.[One hour 50 minutes after buprenorphine administration];Blood pressure measures using a blood pressure machine[Baseline, 1h 50min, 2h 10min ];Oxygen saturation measured with a pulse oximeter[Baseline, 1h 50min, 2h 10min ];Cognitive effects measured with pen and paper test (DSST, Cancellation of 4s)[Baseline and one hour and 50 minutes ];Self reported pain measured with visual analog scale[2h];Placebo/blind assessment (participant reports on a pen and paper form which condition they think they received on a study day)[2h 20 minutes]