Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000682246
Ethics application status
Approved
Date submitted
6/08/2009
Date registered
11/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An open-label, phase 3 study of the safety of the O’Neil Long Acting Naltrexone Implant treatment for substance dependence
Scientific title
An open-label, phase 3 study of the safety of the O’Neil Long Acting Naltrexone Implant treatment for substance dependence
Universal Trial Number (UTN)
Trial acronym
SOCKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
substance dependence 243468 0
morbidity and mortality 243469 0
Condition category
Condition code
Mental Health 239770 239770 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary objective is the assessment of the safety of O'Neil Long-Acting Naltrexone Implants for the treatment of substance dependence both during and after its treatment effects have diminished. Patients will be treated with naltrexone implants.

Naltrexone implants ("O'Neil Implant") consisting of naltrexone loaded poly [trans- (DL)lactide microspheres compressed into tablets with a poly(DL)lactide coating will be inserted into the lower abdomen through a small (approximately 7mm) incision under local anaesthetic as a one-off procedure at commencement of the 12-month study. Each implant’s total weight is approximately 3.1 g with a naltrexone drug loading of 60%. Patient retreatment during the 12-month study is allowed following return to regular heroin use defined as greater than 3 times per month, or in the event of attendance to accident and emergency or hospitalisation for accidental opioid overdose. Persons weighing under 63 kg will be treated by insertion of two, and those over 63kg by insertion of three naltrexone implants.
Intervention code [1] 237085 0
Treatment: Drugs
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240535 0
Several clinical trials have been completed up to publication stage. Adverse Event reported during these trials are as summarised below:

Vomiting from withdrawal
Difficulty with erections
Bleeding, swelling and pain around
implant site
Diarrhoea
Pain at implant site at times
Swollen implant site
Headache
Wound oozing
Redness at implant site
Wound slightly gaping and bruising
leg pain
Acute methadone withdrawal (SAE)
Wound site infection
Left side implant tender
Serous exudation from wound site
Small purulent pimple at wound site
Infected implant site
Mild, intermittent allergy to implant
Insomnia
Abdominal Rash
Discomfort over implant pellets
Weight loss (although more likely
result of excessive amphetamine use)
Infection
Exacerbation of pre-existing depression
Nausea, vomiting from detoxification

Many of the above events are likely associated with withdrawal effects from opioid detoxification.

Adverse events will be assessed through self-reporting, patient questionnaires and during routine clinic visits, as well as those recorded in hospital admissions and health service utilisation records obtained from the Western Australian Data Linkage System.
Timepoint [1] 240535 0
The twelve month primary endpoint will occur at 12 months after implantation. Outcomes are recorded at weeks 1,2,4,8,12,24,39, and 52 post implant.
Primary outcome [2] 240536 0
Adverse events as recorded in hospital admissions and health service utilization records obtained from the Western Australian Data Linkage System.
Timepoint [2] 240536 0
Twelve months post treatment.
Secondary outcome [1] 257104 0
Outcomes are recorded at weeks 1,2,4,8,12,24,39, and 52 post implant. Drug use and relapse patterns will be assessed through self-reporting, patient questionnaires and during routine clinic visits, as well as those recorded in hospital admissions and health service utilisation records obtained from the Western Australian Data Linkage System.
Timepoint [1] 257104 0
Timepoints are recorded at weeks 1,2,4,8,12,24,39, and 52 post implant. Drug use and relapse patterns will be assessed through self-reporting, patient questionnaires and during routine clinic visits, as well as those recorded in hospital admissions and health service utilisation records obtained from the Western Australian Data Linkage System.

Eligibility
Key inclusion criteria
1.Primary diagnosis of substance dependence (defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria).

2.Able and willing to comply with requirements of the protocol.

3.Able and willing to provide written informed consent.

4.Willing to undergo standard detoxification (if required) and implant procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Participation in another clinical drug trial during the last 12 weeks.

2.Women during the lactation period, or pregnant as confirmed by positive urine pregnancy.

3.Severe psychiatric disease, in the opinion of the investigator, which will interfere with the subject's ability to provide research data and informed consent.

4.Subjects who, in the opinion of the investigator, are not likely to complete the study for what ever reason.

5.Subjects with any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data and full physical examination. Stable medical conditions unlikely to affect patient safety or the outcome of the investigation may be acceptable if agreed by the study monitor appointed by the sponsor.

6.Patient lives outside the Perth metropolitan area or cannot provide sufficient contact details to make follow-up over a sustained period successful.

7.Medical condition which requires narcotic treatment for control of pain.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who meet the inclusion/exclusion criteria as assessed by the research and medical staff will be enrolled in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Open cohort
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Use of the WA Data Linkage System to reduce loss to follow-up. Re-implantation upon relapse to substance use or following accidental overdose.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237463 0
Commercial sector/Industry
Name [1] 237463 0
Go Medical Industries Inc
Country [1] 237463 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Go Medical Industries Inc
Address
200 Churchill Ave
Subiaco 6008 WA
Australia
Country
Australia
Secondary sponsor category [1] 236949 0
None
Name [1] 236949 0
Address [1] 236949 0
Country [1] 236949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239591 0
University of Western Australia Human Research Ethics Committee (UWA HREC)
Ethics committee address [1] 239591 0
The University of Western Australia
HREC
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Ethics committee country [1] 239591 0
Australia
Date submitted for ethics approval [1] 239591 0
Approval date [1] 239591 0
15/04/2009
Ethics approval number [1] 239591 0
RA/4/1/2310

Summary
Brief summary
An assessment of the safety and efficacy O'Neil Long-Acting Naltrexone Implants for the treatment of substance dependence both during and after its treatment effects have diminished. Adverse events and substance abuse will be monitored for 12 months post implantation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30016 0
Address 30016 0
Country 30016 0
Phone 30016 0
Fax 30016 0
Email 30016 0
Contact person for public queries
Name 13263 0
Chin-Tark Chan
Address 13263 0
200 Churchill Ave
Subiaco 6008 WA
Australia
Country 13263 0
Australia
Phone 13263 0
+61 (0)8 9388 1700
Fax 13263 0
+61 (0)8 9382 4952
Email 13263 0
[email protected]
Contact person for scientific queries
Name 4191 0
Prof Gary Hulse
Address 4191 0
Professor of Addiction Medicine
University of Western Australia
School of Psychiatry & Clinical Neurosciences,
Unit for Research and Education in Drugs and Alcohol,
D Block, Sir Charles Gairdner Hospital, Nedlands, WA 6009
Country 4191 0
Australia
Phone 4191 0
+61 (0)8 93462280
Fax 4191 0
+61 (0)8 93463828
Email 4191 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.