Pharmacokinetic and pharmacodynamic properties of oral, intramuscular and intravenous methadone in methadone maintenance patients - ROA-meth

• Conditions: Opioid dependence

• Registration Number: EUCTR2005-000108-15-GB
• Lead Sponsor: Institute of Psychiatry, Kings College London & South London and Maudsley NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-03
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified