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
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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
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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
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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
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OpiatesRCT double blind double dummy trial of oral naltrexone
vs. implant naltrexone
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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
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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
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What about alcohol?
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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
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Total adult (15+) per capita consumption, in litres of pure alcohol, 2005a
Global Status Report on Alcohol and Health 2011, WHO
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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
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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
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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
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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
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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%
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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%
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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%
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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
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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
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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