None listed
Conditions
Brief summary
The aim of the study is the in vivo investigation of the plasma concentration and the renal excretion rates following Naltrexone implantation. This will allow us to determine the pharmacokinetic properties of the implants. In other words, the study assesses how quickly naltrexone is released following an implant and how quickly it is processed by the body. Blood and urine samples will be collected frequently over the 1st 72 hour and then at extended intervals to 6 months.
Interventions
This is a phase 1 pharmacokinetic trial of the naltrexone implant.
Subjects will be recruited from patients presenting for treatment for illicit opioid dependence as defined by DSM-1V criteria. Following collection of baseline data, blood and urine, the patient will be treated with a naltrexone implant as per standard clinic procedures. An intravenous cannula will be inserted at the time of implant administration for the collection of pharmacokinetic bloods at 2, 6, 12, 18, 22, 26, 30, 48 and
This is a phase 1 pharmacokinetic trial of the naltrexone implant. Subjects will be recruited from patients presenting for treatment for illicit opioid dependence as defined by DSM-1V criteria. Following collection of baseline data, blood and urine, the patient will be treated with a naltrexone implant as per standard clinic procedures. An intravenous cannula will be inserted at the time of implant administration for the collection of pharmacokinetic bloods at 2, 6, 12, 18, 22, 26, 30, 48 and 72 hours post-procedure. Patients will be requested to collect a 24 hoour urine sample beginning 24 hours after implant adminsitration. Following this initial intensive sampling schedule and removal of the cannula line, patients will continue to have blood collected at weekly, then fortnightly intervals during routine clinical follow up until 6 months post-procedure. Regular urine samples will be collected for urine drug screens. Self-reported health data will be collected during the 6 month observation period and the site of implant will be assessed for infection or allergic responses.
Sponsors
School of Psychiatry and Clinical Neurosciences, University of Western Australia
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Opioid dependence: no prior GMP naltrexone implants, informed consent
Exclusion criteria
No other naltrexone implants in the past 2 years
Outcome results
None listed