stapleford-athens 2011 international addiction conference naltrexone implants for the treatment of...
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Stapleford-Athens 2011International Addiction Conference
Naltrexone Implants for the Treatment of Alcohol Dependence
Dr George O’[email protected]
Fresh Start Recovery ProgrammePerth, Western Australia
Physiology – changing physiology 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
Empowerment 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
OpiatesRCT double blind double dummy trial of oral naltrexone
vs. implant naltrexone
Implant vs. Injection (Vivitrol)Naltrexone blood concentrations
0
5
10
15
20
25
30
0 50 100 150 200 250 300 350 400 450
Tim e (days)
Na
ltre
xo
ne
(n
g/m
l)
Vivitrol 380mg IM O'Neil Triple implantsLog. (O'Neil Triple implants) Poly. (Vivitrol 380mg IM)
Estimated duration of therapeutic effectAssuming 4ng/ml, Go Medical = 100 days, Vivitrol 17daysAssuming 3ng/ml, Go Medical = 140 days, Vivitrol 21daysAssuming 2ng/ml, Go Medical = 200 days, Vivitrol 28daysAssuming 1ng/ml, Go Medical = 272 days, Vivitrol 31days
2010-11 Estimation of Use
Alcohol
Responses to questions: Have you had any drinks since last follow up?
Total No. Responder
sAbstinence
% Abstinence
of responders
Abstinence or
reduction in drinking
% of responders (RR <0.3)
(<3 DD/M)
Non-responders
% of Non-responders
Week 1 28 14 50.00% 22 78.57% 6 21.43%
Week 4 15 6 40.00% 12 80.00% 3 20.00%
Week 12 17 11 64.71% 13 76.47% 4 23.53%
Week 24 9 3 33.33% 6 66.67% 3 33.33%
Total 69 34 49.28% 53 76.81% 16 23.19%
Total Number of implants 58
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 300,000-600,000 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
Male Female
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 Patients Total Hospital Admissions
Admissions Patients Cost (AUD)
Before 162 56 $650 000
After 86 7 $440 000
% Reduction 46.9% 87.5% 32.3%
Mental Health Costs Savings
105 Patients Total Hospital Admissions
Admissions Patients Cost (AUD)
Before 543 25 $41 000
After 195 6 $14 500
% Reduction 64.1% 76.0% 64.6%
Emergency Cost Savings
105 Patients Emergency Department
Admissions Patients Cost (AUD)
Before 313 69 $113 500
After 192 10 $69 500
% Reduction 38.7% 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 • [email protected]• I am keen to collaborate with RCT work
to validate the potential with implants in alcohol patients
Contact Information• Dr George O’Neil• Email: [email protected]• 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