1 4 gram naltrexone implant delivers therapeutic blood levels for over 6 weeks n.
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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

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

Peter Coleman MD

The Coleman Institute

Richmond Va. USA

background
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
original wedgewood design
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
new wedgewood design
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
current study design
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
surgical procedures
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
lab procedures
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
results patient characteristics
Results – Patient Characteristics
  • 2 men and 4 women
  • Ages 22 to 63.
  • Median age 46
  • 4 Alcoholics and 2 Opiate Dependence
results patient completion
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
results adverse effects
Results – Adverse Effects
  • No patients developed inflammation or infection
  • No other adverse effects
conclusions
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
conflict of interest statement
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.