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

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

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

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

Opiates RCT double blind double dummy trial of oral naltrexone vs. implant naltrexone

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

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 % %621.43% Week % %320.00% Week % %423.53% Week %666.67%333.33% Total % % % Total Number of implants58

What about alcohol?

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 persons

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

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 Male Female

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 MaleFemale

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

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

Hospital Cost Savings 105 PatientsTotal Hospital Admissions AdmissionsPatientsCost (AUD) Before16256$ After867$ % Reduction46.9% 87.5% 32.3%

Mental Health Costs Savings 105 PatientsTotal Hospital Admissions AdmissionsPatientsCost (AUD) Before54325$ After1956$ % Reduction64.1% 76.0% 64.6%

Emergency Cost Savings 105 PatientsEmergency Department AdmissionsPatientsCost (AUD) Before31369$ After19210$ % Reduction38.7% 85.5% 38.8%

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

Conclusions Planned RCT or named patient work I am keen to collaborate with RCT work to validate the potential with implants in alcohol patients

Contact Information Dr George O’Neil Phone –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