2. Stapleford-Athens 2011 International Addiction Conference Naltrexone Implants for the Treatment of Alcohol Dependence Dr George O’Neil email@drgeorgeoneil.com Fresh Start Recovery Programme Perth, Western Australia

3. email@drgeorgeoneil.com Physiology – changing physiology Physiology – changing physiology Housing “where you know you belong” – The essence of a home is love, joy, peace, patience, gentleness, kindness and self control Housing “where you know you belong” – The essence of a home is love, joy, peace, patience, gentleness, kindness and self control Relationships – self, God, family, community Relationships – self, God, family, community Empowerment Empowerment Education, Employment, Exit from rehab, Entry to Society – occupational therapy, short term employment, career, university/training Education, Employment, Exit from rehab, Entry to Society – occupational therapy, short term employment, career, university/training Follow up- PHREE program

4. Naltrexone Oral registered for use in alcohol and opiate dependence Poor compliance with oral naltrexone Development of a sustained release naltrexone preparation Maintain blood levels above 1 to 2 ng/ml email@drgeorgeoneil.com

5. The O’Neil Long Acting Naltrexone Implant Subcutaneous implant Produced under Good Manufacturing Practice (GMP) Maintains blood levels above 1 to 2 ng/ml for ~6 months email@drgeorgeoneil.com

6. Opiates RCT double blind double dummy trial of oral naltrexone vs. implant naltrexone email@drgeorgeoneil.com

7. Implant vs. Injection (Vivitrol) Estimated duration of therapeutic effect Assuming 4ng/ml, Go Medical = 100 days, Vivitrol 17days Assuming 3ng/ml, Go Medical = 140 days, Vivitrol 21days Assuming 2ng/ml, Go Medical = 200 days, Vivitrol 28days Assuming 1ng/ml, Go Medical = 272 days, Vivitrol 31days email@drgeorgeoneil.com

8. 2010-11 Estimation of Use Alcohol Responses to questions: Have you had any drinks since last follow up? Total No. Responder s Abstinence % Abstinence of responders Abstinence or reduction in drinking % of responders (RR <0.3) (<3 DD/M) Non- responders % of Non- responders Week 1281450.00%2278.57%621.43% Week 415640.00%1280.00%320.00% Week 12171164.71%1376.47%423.53% Week 249333.33%666.67%333.33% Total693449.28%5376.81%1623.19% Total Number of implants58 email@drgeorgeoneil.com

10. What about alcohol?

12. Major disease and injury categories causally linked to alcohol Neuropsychiatric disorders: –Epilepsy –4.6% of global disability adjusted life years Gastrointestinal diseases: –liver cirrhosis and pancreatitis Cancer: –cancers of the colorectum, female breast, larynx, liver, oesophagus, oral cavity and pharynx. Intentional injuries: –linked to suicide and violence. Unintentional injuries: –This include road traffic accidents, falls, drowning, poisoning Cardiovascular diseases: –the beneficial cardio protective effect of drinking disappears with heavy drinking occasions. –detrimental effects on hypertension, cardiac dysrhythmias and haemorrhagic stroke Fetal alcohol syndrome and pre-term birth complications: Diabetes mellitus: –heavy drinking is detrimental 1 Year Alcohol use disorders 300,000-600,000 persons email@drgeorgeoneil.com

13. Total adult (15+) per capita consumption, in litres of pure alcohol, 2005a Global Status Report on Alcohol and Health 2011, WHO email@drgeorgeoneil.com

14. Prevalence of Heavy Episodic Drinking in Americas Global Status Report on Alcohol and Health 2011, WHO HED >60g of Alcohol on at least one occasion in the past 7 days email@drgeorgeoneil.com Male Female

15. Prevalence of Heavy Episodic Drinking in Rest of the World Global Status Report on Alcohol and Health 2011, WHO HED >60g of Alcohol on at least one occasion in the past 7 days email@drgeorgeoneil.com MaleFemale

16. Cochrane 2010 – Opioid Antagonist for Alcohol Dependence 50 RCTs 7793 participants Average use 3 months Average benefit –1 per 9 patients helped Compliance general poor Potential for sustained release too sparse for conclusions Gastrointestinal symptoms common email@drgeorgeoneil.com

17. Alcohol Research Used WA Data Linkage System, ethics (2008) Cross match alcohol patients treated with naltrexone implants against: –Hospital admission –Emergency (ED) attendances –Mental health (MH) out-patient 12 months before treatment and 12 months after treatment email@drgeorgeoneil.com

18. Hospital Cost Savings 105 PatientsTotal Hospital Admissions AdmissionsPatientsCost (AUD) Before16256$650 000 After867$440 000 % Reduction46.9% 87.5% 32.3% email@drgeorgeoneil.com

19. Mental Health Costs Savings 105 PatientsTotal Hospital Admissions AdmissionsPatientsCost (AUD) Before54325$41 000 After1956$14 500 % Reduction64.1% 76.0% 64.6% email@drgeorgeoneil.com

20. Emergency Cost Savings 105 PatientsEmergency Department AdmissionsPatientsCost (AUD) Before31369$113 500 After19210$69 500 % Reduction38.7% 85.5% 38.8% email@drgeorgeoneil.com

21. Results in the First Year Following Naltrexone Implants in Alcohol Patients Patients number requiring ED, MH and admissions all decreased by >75% Costs decreased in each area by >30%, with 64% in MH Numbers of admissions decreased by >40% with 64% in MH Cost savings for the 56 requiring admission = $3763 AUD per patient email@drgeorgeoneil.com

22. Conclusions Planned RCT or named patient work email@drgeorgeoneil.com I am keen to collaborate with RCT work to validate the potential with implants in alcohol patients email@drgeorgeoneil.com

24. Contact Information Dr George O’Neil Email: email@drgeorgeoneil.comemail@drgeorgeoneil.com Phone +61 893881991 –Perth (GMT+8) 6-8am or 7-11pm –London (GMT) 10-12pm or 11am-3pm –New York (GMT-5) 5-7pm or 6-10am –Los Angeles (GMT-8) 2-4pm email@drgeorgeoneil.com