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1.4 Gram Naltrexone Implant delivers therapeutic blood levels for over 6 weeks

1.4 Gram Naltrexone Implant delivers therapeutic blood levels for over 6 weeks. Peter Coleman MD The Coleman Institute Richmond Va. USA. Background. Oral Naltrexone approved in the US in 1984 Minimal use in practice because of poor compliance

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1.4 Gram Naltrexone Implant delivers therapeutic blood levels for over 6 weeks

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  1. 1.4 Gram Naltrexone Implant delivers therapeutic blood levels for over 6 weeks Peter Coleman MD The Coleman Institute Richmond Va. USA

  2. Background • Oral Naltrexone approved in the US in 1984 • Minimal use in practice because of poor compliance • Naltrexone implants began being used since the late 1990s • Some of the earliest implants in widespread use were compounded by Wedgewood pharmacy • Since then a number of innovations and improvements

  3. Original Wedgewood Design • 1 gram implant • Study by Olsen et al. showed levels above 1ng per ml for median time of 55 days • Range of only 30 to 80 days

  4. New Wedgewood Design • 1.4 grams of Naltrexone Base • Small amount of Mg Stearate as lubricant • Same diameter • Same introducer – 3 ml beveled syringe • Tighter compression – 25 kP • Slightly longer length

  5. Current Study – Design • 6 patients who were scheduled to receive a Ntx implant • Informed consent • Exclusion if any Ntx in the previous 6 months • Therapeutic Naltrexone level defined as greater than 1 ng per ml

  6. Surgical Procedures • Routine sterile surgical procedure • 0.5 cc Triamcinolone Acetonide infused around the implant after wound sutured • 500 mg Cefazolin infused around the implant after wound sutured

  7. Lab procedures • Blood drawn 24 hours after implantation • Further blood draws at: • 4 weeks • 6 weeks • 8 weeks • Additional 2 week intervals until levels dropped below 0.5ng per ml • Blood analyzed at National Medical Services • Lab Sensitivity levels of 0.01 ng per ml with lowest cut off of 0.5ng per ml

  8. Results – Patient Characteristics • 2 men and 4 women • Ages 22 to 63. • Median age 46 • 4 Alcoholics and 2 Opiate Dependence

  9. Results – Patient Completion • 3 out of 6 completed the study as designed • The other three provided useful data • One patient relapsed on alcohol after 8 weeks and was lost to follow up • One provided blood levels until the end of week 12 and then was lost to follow up • One had a therapeutic level at week 14 and elected to get a new implant at that point

  10. Percentage of patients with Therapeutic Naltrexone levels

  11. Duration of Naltrexone levels over 1 ng per ml for each patient in the study

  12. Naltrexone blood levels over time 6 patients

  13. Results – Adverse Effects • No patients developed inflammation or infection • No other adverse effects

  14. Conclusions • All patients had therapeutic Naltrexone levels after 6 weeks • 83% had therapeutic levels after 8 weeks • 50% of patients had therapeutic levels after 14 weeks • Clearly a larger variation between patients • Blood levels at 24 hours may be somewhat predictive of duration of these implants

  15. Conflict of Interest statement • This research was supported by Wedgewood Pharmacy who provided free implants for the participants and a small stipend to the author to cover lab and office costs.

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