None listed
Conditions
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.
Interventions
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
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.
Sponsors
Go Medical Industries Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed