None listed
Conditions
Brief summary
Buprenorphine and methadone are medications used in the treatment of opioid dependence. Buprenorphine is a partial opioid agonist, meaning it has a ceiling effect, and thus transferring from a full opioid agonist such as methadone can be challenging because of the risk of causing precipitated opioid withdrawal for the patient. Current standard practice is to reduce Methadone doses to lowest dose possible , wait until the patient is in moderate withdrawal, then commence buprenorphine. This can be a time-consuming process, often requiring hospital admission for a week, or even longer in some cases, putting additional strain on public health systems. Micro-dosing is a novel approach to transitioning patients on full-agonist opioids (heroin, methadone, oxycodone, morphine) to buprenorphine using very small doses of buprenorphine concurrently with a full opioid agonist. The aim of this prospective dual arm, clinical trial is to establish a safe micro-dosing regimen for completing transfers from methadone to buprenorphine, and compare outcomes in patients that undergo micro-dose transfers from methadone to buprenorphine to those completing a standard of care transfer. Our hypothesis is that micro-dosing is a safe method for transitioning patients from methadone to buprenorphine in the community.
Interventions
Transfer of patients from methadone to buprenorphine using micro-dosing technique.
Dosing regimen (where X is current dose of methadone):
Day 1: Methadone Xmg daily per oral liquid; Buprenorphine 0.2mg twice a day sublingual tablet
Day 2: Methadone Xmg daily per oral liquid; Buprenorphine 0.4mg twice a day sublingual tablet
Day 3: Methadone Xmg daily per oral liquid; Buprenorphine 2mg daily sublingual tablet
Day 4: Methadone Xmg daily per oral liquid; Buprenorphine 4mg daily sublingual tablet
Da
Transfer of patients from methadone to buprenorphine using micro-dosing technique. Dosing regimen (where X is current dose of methadone): Day 1: Methadone Xmg daily per oral liquid; Buprenorphine 0.2mg twice a day sublingual tablet Day 2: Methadone Xmg daily per oral liquid; Buprenorphine 0.4mg twice a day sublingual tablet Day 3: Methadone Xmg daily per oral liquid; Buprenorphine 2mg daily sublingual tablet Day 4: Methadone Xmg daily per oral liquid; Buprenorphine 4mg daily sublingual tablet Day 5: Methadone Xmg daily per oral liquid; Buprenorphine 8mg daily sublingual tablet Day 6: Methadone 1/2 Xmg per oral liquid; Buprenorphine 16mg daily sublingual tablet Day 7: Methadone 1/4 Xmg per oral liquid; Buprenorphine 16-32mg daily sublingual tablet OR 16-32mg subcutaneous injection, at the discretion of the treating physician From day 8, the intervention has ceased, and patients can be treated with buprenorphine at the discretion of the treating physician in line with current guidelines and recommendations. Patients are to be reviewed each day prior to their morning dose. Supervised dosing will occur for all morning dosing. Unsupervised dosing will occur only the evening doses on days 1 and 2. These doses will be given to the patient on the morning of day 1 and 2 respectively.
Sponsors
Drug Health Services, Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged greater than or equal to 18 years - Able to provide consent and comply with the study protocol - Prescribed a stable dose of methadone for 5 days or more for opioid dependence - Wanting to transfer to buprenorphine
Exclusion criteria
Pregnant Unable to provide consent or comply with the study protocol Contraindication to buprenorphine therapy Allergy to buprenorphine therapy Not currently prescribed methadone
Outcome results
None listed