Opioid dependence
Conditions
Interventions
physeptone 50mg/ml
Product Name: Physeptone 25mg//ml
Trade Name: Methadone mixture DTF 1mg/ml
Product Name: Methadone Mixture DTF 1mg/ml
Pharmaceutical Form: Oral solution
INN or Proposed INN: Methadone hydrochloride BP 1mg/ml
Other descriptive name: Ph
physeptone 50 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methadone hydrochloride solution for injection
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type
Sponsors
Institute of Psychiatry, Kings College London & South London and Maudsley NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are: (1) patients who have been in oral methadone maintenance treatment for at least 6 weeks; (2) on a stable methadone dose between 40 and 200mg for at least 2 weeks; (3) aged between 18 and 65 years; (4) a history of having injected drugs in the past 6 months. (5) able and willing to participate in the study procedures (e.g. no impending prison sentence) and provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The main exclusion criteria are 1. a significant medical condition which may significantly impact upon PK and PD measures, including severe psychiatric comorbidity, severe hepatic or renal disease, pregnancy, chronic pain conditions; 2. concurrent medications which may significantly alter methadone metabolism or response, particularly CYP3A inducers or inhibitors; 3. currently dependent to other substances such as alcohol, benzodiazepines, cocaine, amphetamines or heroin, which may be interfere with study outcome measures; 4. poor venous access, such that cannula insertion and blood sampling is likely to be difficult; 5. currently participating in another research project that may interfere with the present study (or vice versa) or have done so in the past 3 months; 6. not proficient in English to the extent that they cannot understand clinical and research procedures involved in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this project is to characterise differences in the pharmacokinetics and pharmacodynamics (i.e., metabolism and response) of methadone administered by the intravenous, intramuscular and oral routes in methadone maintenance patients. The principal objective of the study will be to compare mean values and the degree of individual variability in methadone bioavailability for the oral and intramuscular routes in comparison to the intravenous route. ;Secondary Objective: Secondary objectives of the project will be: (1) to characterise the impact of administration route on safety of injectable methadone maintenance treatment with regard to possible risks of (a) QTc prolongation, (b) hypoxemia, and (c) parameters of sedation; and (2) to investigate saliva methadone concentrations as an alternative to plasma methadone concentrations for studies of the pharmacokinetics and pharmacodynamics of methadone. ;Primary end point(s): Bioavailability (mean AUC for methadone plasma levels); physiological (e.g. PO2, respiratory rate, blood pressure) and subjective measures of drug effects | — |
Countries
United Kingdom
Outcome results
None listed