None listed
Conditions
Interventions
Subjects will be randomised to either the TDM group or to usual care. Each group will receive the same schedule of appointments for case management and three-monthly testing sessions. The usual care group will receive usual care from their clinic medical officer, including being able to request case increments. The TDM group will be transferred to the care of a study medical officer for 6 months, and be prescribed dose increments to achieve a trough plasma R-methadone concentration of 100ng/ml.
Subjects will be randomised to either the TDM group or to usual care. Each group will receive the same schedule of appointments for case management and three-monthly testing sessions. The usual care group will receive usual care from their clinic medical officer, including being able to request case increments. The TDM group will be transferred to the care of a study medical officer for 6 months, and be prescribed dose increments to achieve a trough plasma R-methadone concentration of 100ng/ml. Any subject in the TDM group already at 100ng/ml will have their trough concentrations raised to 200ng/ml using standard clinic protocols for dose increments. Patients will be monitored throughout for signs of adverse effects and dose changes will be adjusted accordingly under the supervision of an experienced senior medical officer. After targeted dose increments, trough concentrations will be measured again at 6 weeks and a final dose adjustment made. Testing sessions will be at 3 and 6 months and involve 2 days of observation.
Sponsors
The Langton Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Agree to and be capable of signing an informed consent form.In treatment at least 2 monthsOn a stable methadone dose for at least 4 weeksOn a methadone dose greater than or equal to 50mg/dayUse heroin 4 times or more in the last monthCurrent methadone prescriber consents to subject's participation in the research.
Exclusion criteria
Considered unwilling, unable or unlikely to comply with the study protocolPregnant or breast feedingUsing drugs and dietary components known to interact with methadone pharmacokinetics (including antipsychotics, fluvoxamine, St John's Wort, Grapefruit juice)Unstable medical conditions (liver disease with jaundico/ascites/encephalopathy, structural heart disease, psychosis.
Outcome results
None listed