The FDA has not given a specific approval for the administration of naltrexone by having it implanted under the skin of an individual. Prescription uses of naltrexone can be administered in several forms – as a pill and as a monthly injection. The implant is compounded for an individual only after a prescription is written by a medical doctor who has determined that his or patient is a good candidate for the implant. Only a licensed medical doctor can insert the implant into his or her patient who consents to this treatment option.
The implant is a specially compounded, implantable formulation of naltrexone that is made specifically for each individual program patient participant only after a prescription is written by medical caregiver who deems that the individual patient is a good candidate for the implant formulation. Compounding is a common and legal process used by licensed pharmacies to create special formulation and/or combinations of FDA approved drugs by prescription. The pharmacies that make each implant must strictly follow state and federal compounding laws. Naltrexone implants have been used successfully and safely worldwide for approximately 20 years. Tens of thousands of individuals worldwide have successfully undergone treatment for addiction with the use of naltrexone implants.
No. There have been no clinical trials testing the efficacy of the BioCorRx® Recovery Program. There may be clinical trials in the future.
No. Alcoholism and drug addiction is a chronic, complex, and multi-factorial disease. There is no magic cure. It should be considered a chronic brain disease. Alcoholism, as with most addictions, is a result of psychosocial AND physiological malfunctions. BOTH the physical aspect and the psychosocial/behavioral/emotional aspect of this disease should be addressed to have the highest chance of obtaining, and maintaining, sobriety.
This is a very good question. Our country’s treatment of addiction has been absurdly ineffective and misguided since its inception. We have done a great job with the psychosocial/behavioral aspect of addiction but still have abysmally low rates of sobriety. Why is that? It is because the physiologic and pharmacologic aspect of treatment has been ignored and under-developed. It would be unheard of to withhold insulin from an un-controlled diabetic and insist upon only providing intensive nutritional and exercise recommendations. Proper nutrition and exercise would certainly help, and that behavioral modification is required for success. But, quite simply, for many diabetics this would not be sufficient. Many diabetics require insulin in addition to dietary modification and motivation. The treatment of addiction should be approached in this comprehensive manner as well
Naltrexone is a very safe medication that has been used for many years. The implants are generally very well tolerated. Beside the side-effects mentioned above, program participants can report itching, tenderness, swelling, pain, irritation, inflammation, or infection around the surgical site. The majority of cases of irritation or inflammation resolve with time. Often, antihistamines and topical and/or oral steroids are used to help treat the local inflammation. In cases of infection, antibiotics may be needed. In the very unlikely case of severe infection or inflammation, a doctor may recommend removal of the implant. The implant is contraindicated in individuals with acute hepatitis, advanced liver disease, or kidney failure. Pregnant or breastfeeding women should consult with their physician before beginning Naltrexone treatment. The implant is surgically placed, and there will be a small linear surgical scar. Each individual scars differently. In some cases, a small nodule of fibrous tissue may remain palpable under the skin. Although very unlikely, as with any foreign body there is a risk of rejection, tissue breakdown, and necrosis.
Consult with a physician, but most medications can be taken while on naltrexone. It’s important to let the doctor know what medications are being taken prior to naltrexone therapy so that any contraindications can be determined. Naltrexone will block the effect of opioid pain relievers so it is important to notify medical personnel if you are receiving naltrexone treatment. It may also render cough and cold medications containing opioids ineffective. During naltrexone therapy, program participants carry a medical card that may be carried discreetly in one’s wallet or purse. In the event of that someone on naltrexone therapy requires pain relief due to any medical circumstances, alternative analgesia or high doses of opioid medication may be administered in the monitored hospital setting. There are a number of readily available alternative pain relievers that can be used in conjunction with naltrexone. Acetaminophen, aspirin, ibuprofen, naproxen, gabapentin, lidocaine patches, muscle relaxers, steroids, and various other alternative pain relief and anti-inflammatory medications may be effectively used while on naltrexone therapy. In addition, the implant can be removed and narcotics administered after naltrexone is out of the patient’s system. This can take several hours or days.
The BioCorRx® Recovery Program is comprehensive, so as to provide each one of program participant the highest opportunity for success. In addition to utilizing medicine to address the physical and neurobiological aspect of the disease, program participants will engage in intensive and individualized one-on-one sessions with licensed drug and alcohol counselors (most of whom are recovered addicts.) As discussed above, to obtain and maintain sobriety, the physical AND the psychosocial/behavioral aspect of addiction must be addressed. The naltrexone implant is a very effective tool that, in some people, virtually eliminates the physical cravings for an extended period of time. Once physical cravings are suppressed, the individual can then focus entirely on the equally important and difficult psychosocial aspect of the recovery. Study after study indicates that medical therapy in combination with counseling is superior to medical therapy or counseling alone. It is critical to understand that addiction is a lifelong struggle. Our program has remarkable success in assisting to accomplish sobriety in the vast majority of program participants. Once successfully enrolled in our program, and liberated from the shackles of alcohol or drug addiction, we strongly encourage and endorse long-term participation in support groups (12-step, or otherwise) to maintain personal focus, lifelong surveillance, and to offer a helping hand to others that fight a similar struggle.
IMPORTANT: Many program participants receiving the implant may feel that they are “cured” in a couple of months due to the effectiveness of the implant and therefore, do not remain as dedicated to their counseling sessions. There is no known cure for addiction. The implant is a very effective tool to relieve the burden of hyper-focused cravings but the psycho-social and behavioral component of the disease must be modified or relapse is almost certain. Clinics using the program have reported a very high success rate with those who completed the entire counseling portion of the program and much lower success rates with those who DO NOT complete the program. The Counseling is critical to success.