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Trial registered on ANZCTR


Registration number
ACTRN12607000353493
Ethics application status
Approved
Date submitted
12/06/2007
Date registered
2/07/2007
Date last updated
14/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pharmacokinetic trial of Good Manufacturing Practice (GMP) naltrexone implants in a small cohort of illicit opioid dependent persons
Scientific title
A pharmacokinetic trial of Good Manufacturing Practice (GMP) naltrexone implants in a small cohort of illicit opioid dependent persons
Universal Trial Number (UTN)
Trial acronym
PK Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetic properties of a sustained release naltrexone implant in illicit opioid dependent persons 1910 0
Condition category
Condition code
Mental Health 2001 2001 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 1821 0
None
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2823 0
Blood levels of naltrexone and 6-beta-naltrexol over 72 hours.
Timepoint [1] 2823 0
Samples collected at 2, 6, 12, 18, 22, 26, 30, 36, 48 and 72 hours.
Primary outcome [2] 2824 0
Renal clearance by measuring the urinary concentration of naltrexone and 6-beta-naltrexol from all urine passed between 24 and 48 hours.
Timepoint [2] 2824 0
Between 24 and 48 hours.
Secondary outcome [1] 4765 0
1) Plasma concentration of naltrexone and 6-beta-naltrexol from 72 hours to 6 months determined from blood samples collected.
Timepoint [1] 4765 0
Post-procedure: 1, 2, 3, 4, 6 and 8 weeks, then monthly to 6 months.
Secondary outcome [2] 4766 0
2) Renal clearance by measuring the urinary concentration of naltrexone and 6-beta-naltrexol from 72 hours to 6 months.
Timepoint [2] 4766 0
Determined by 24 hour urine samples, and other samples collected at 1,3 and 6 months.
Secondary outcome [3] 4767 0
3) Other health outcome measures including evaluation of wound/implant site.
Timepoint [3] 4767 0
Baseline to 6 months

Eligibility
Key inclusion criteria
Opioid dependence: no prior GMP naltrexone implants, informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No other naltrexone implants in the past 2 years

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2142 0
Government body
Name [1] 2142 0
Commonwealth Government Australian Industries Grant
Country [1] 2142 0
Australia
Primary sponsor type
University
Name
School of Psychiatry and Clinical Neurosciences, University of Western Australia
Address
35, Stirling Highway, Crawley
Country
Australia
Secondary sponsor category [1] 1946 0
None
Name [1] 1946 0
n/a
Address [1] 1946 0
Country [1] 1946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3940 0
University of Western Australia, HREC
Ethics committee address [1] 3940 0
35, Stirling Highway, Crawley
Ethics committee country [1] 3940 0
Australia
Date submitted for ethics approval [1] 3940 0
Approval date [1] 3940 0
22/09/2006
Ethics approval number [1] 3940 0
RA/4/1/1554

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27635 0
Address 27635 0
Country 27635 0
Phone 27635 0
Fax 27635 0
Email 27635 0
Contact person for public queries
Name 11010 0
Dr Robert Tait
Address 11010 0
School of Psychiatry & Clinical Neurosciences
QE II Medical Centre
D Block
M 521
Nedlands WA 6009
Country 11010 0
Australia
Phone 11010 0
+61 8 93462281
Fax 11010 0
Email 11010 0
[email protected]
Contact person for scientific queries
Name 1938 0
Professor Gary Hulse
Address 1938 0
School of Psychiatry & Clinical Neurosciences
QE II Medical Centre
D Block
M 521
Nedlands WA 6009
Country 1938 0
Australia
Phone 1938 0
+61 8 93462280
Fax 1938 0
Email 1938 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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