California Addiction
Medical Group
Advanced Treatment of Opioid & Alcohol Addiction
Alcohol Abuse & the Opiate Epidemic
The #1 goal for recovering addicted patients is to decrease their relapse rate and therefore decrease the resulting death rates.
The most effective approach consists of:
Decrease Cravings & Attraction to Drugs
Provide Support and Psychological Infrastructures
Decrease triggers and Increase Environmental Changes
Naltrexone and Probuphine Implants
The effectiveness of Extended Release Naltrexone
Takes the Cravings Away
Extinguishes the Obsession of focusing on your Next Fix
Reduce Relapse Rate and Maintain Sobriety through Decreased Cravings
Comparison of Naltrexone Delivery Systems
| Naltrexone 50 mg Tablets |
Vivitrol Intramuscular |
Naltrexone Implant | |
|---|---|---|---|
| Delivery Method | Oral | Intramuscular Injection | Subcutaneous |
| Frequency of Administration | Every day | Every month | Every 3 -6 months |
| Advantages | Simple to administer | Don’t have to think about it for 30 days; Non-cyclic relatively constant blood levels | Don’t have to think about it for 90 – 180 days; Non-cyclic relatively constant blood levels; Gives patient a more reasonable time to form the mindset of not using by allowing psychological, social and behavioral modification treatment methods to be effective; Acts as an additional “insurance” not to use again. |
| Disadvantages | Compliance major disadvantage: Must take daily so it is easy to start using again by just stop taking it for a few days. | Painful injection at site of administration; 30 day effectiveness period is generally not enough time to form the mindset of not using; | Although the active ingredient, Naltrexone, has been FDA approved since 1984, its delivery in the form of an implant has not. However, this extended release implant is compounded by a licensed pharmacy under strict quality control and sterilization standards. Requires outpatient surgery center implantation, however recovery is rapid typically uneventful. |
An Evidence Based Approach to Treatment
The use of Compounded Naltrexone Implants was published in an AMA associated peer reviewed journal.
Demonstrated the efficacy of Naltrexone controlled extended release devices.
Compared the use of oral and intramuscular versus implanted Naltrxone.
Showed decreases in cravings & attraction to drugs.
Naltrexone implants significantly improved the rate of relapse and therefore lowered the death rates of these opiate dependent patients.
Naltrexone Implant
Naltrexone significantly improved the rate of relapse and therefore lowered the death rates of these opiate dependent patients with a confidence level of p< .01.
This study appeared in the AMA psychiatric literature network published in the Archives of General Psychiatry1. This was a double blinded, double dummy (cross-over) randomized controlled study recruiting over 300 patients. An additional earlier RCT was conducted and the results published with a p< .05 demonstrating the effectiveness of extended release Naltrexone2
1. Arch Gen Psychiatry, September 2012; 69(9): 973-981. Also see http://archpsyc.jamanetwork.com
2. British J of Psych (2009) 194, 541-546: 10.1192/bjp.bp.055319
Mode of Action
Naltrexone is an opiate antagonist binding to μ-opiate receptors. It was FDA approved for opiate addiction in 1984 and for alcohol in 1994. Vivitrol injections of extended release Naltrexone lasts about one month and was approved in 2006.
Although the active ingredient, Naltrexone, has been FDA approved since 1984, its delivery in the form of an implant has not. However, this extended release implant is compounded by a licensed pharmacy under strict quality control and sterilization standards and has been available for over 15 years. It typically remains in the subcutaneous tissue of the left or right abdominal quadrant for 3 – 6 months, then biodegrades and is dissolved. Depending on pellet design and the patient’s metabolism, Naltrexone blood levels remain therapeutic during this time period.
Comprehensive Medical Assessment
Internal Medicine Pre-op Exam includes detailed medical history of the opiate and/or alcohol abuse and dependency:
Physical Exam with particular emphasis on signs of substance abuse and pre-operative clearance
Psychiatric Examination to determine patient’s probable success as a result of this procedure
Resting 12 lead EKG with rhythm strip
Laboratory including related co-morbidities i.e. STDs, HepC etc and pre-op CBC c diff, metabolic screen, blood coagulation + Urine Toxicology screen for a minimum of 12 commonly abused substances
The Procedure
On the day of the implant the patient is admitted to a fully licensed and certified surgical outpatient center and again undergoes a witnessed urine toxicology screen.
Patient is prepared per standard protocol for a pre-surgical subcutaneous procedure. Intravenous anesthetic is administered and a small 1 to 1.5cm incision is made in order to insert the Naltrexone implant. The implant is biodegradable and dissolves in 3 or 6 months depending on the compounding pharmacy that manufactured it.
Post surgical monitoring is done over the next 3-6 months and Includes immediate wound healing and urinary Naltrexone metabolite level
Patient Qualifications
The patient must have an extensive history of alcohol or opiate abuse with multiple attempts at treatment in licensed detox and recovery facilities resulting in relapses and failure. Must be clean, sober and stable for at least 30 days. Must have at least a 7-10 day prior exposure to Naltrexone in any form prior to entering this program.
Probuphine Implant
Appropriate Candidates for this treatment approach to the opiate addiction epidemic
This method is only appropriate for opiate (not alcohol addicted) patients who have been maintained on a low daily dose of sublingual Suboxone (buprenorphine) and have been stable for at least 60 days on a maximum dose of 4mg per day.
This implant, the procedure utilized to implant, and specific physician training requirements were FDA approved in 2016 while the active drug buprenorphine (a partial opiate agonist) was approved in 2002 for opiate detox.
