None listed
Conditions
Brief summary
The study aims to examine the effect of buprenorphine for pain in opioid dependent people. Most research with buprenorphine for pain has been conducted using doses that are at least 10 times lower than those used in opioid dependent people. This study aims to examine if increasing doses of buprenorphine result in improved pain response in the dose ranges used for treatment of opioid dependence.
Interventions
Examining the effect of administering a participants usual daily dose of sublingual buprenorphine (range 4-16mg)(in the form of buprenorphine-naloxone) compared with 150% and 200% of the usual daily dose, in buprenorphine maintained participants on experimental pain threshold and tolerance using the cold pressor test. Each dose condition will be tested once (single-dose only). Participants will have three wash out days in between each study session. To maintain the blind participants will receiv
Examining the effect of administering a participants usual daily dose of sublingual buprenorphine (range 4-16mg)(in the form of buprenorphine-naloxone) compared with 150% and 200% of the usual daily dose, in buprenorphine maintained participants on experimental pain threshold and tolerance using the cold pressor test. Each dose condition will be tested once (single-dose only). Participants will have three wash out days in between each study session. To maintain the blind participants will receive the balance of their double dose, i.e. 100%. 50% or 0% of their usual dose at the end of the session so that participants receive a full 'double dose' (i.e. twice their usual maintenance dose) on the study day. Consistent with usual double dosing procedures, they will not receive a dose of buprenorphine on the day following the session. On the next two days of the washout period the participants usual dose will be administered. Study medication will be administered under supervised conditions and urine drug screening will be used to confirm substance use prior to each session.
Sponsors
South Eastern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Outcome results
None listed