An open-label, phase 3 study of the safety of the O’Neil Long Acting Naltrexone Implant treatment for substance dependence

Phase 3

• Conditions: substance dependence; morbidity and mortality; Mental Health - Addiction

• Registration Number: ACTRN12609000682246
• Lead Sponsor: Go Medical Industries Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified