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What is the BioCorRx® Recovery Program (formerly the Start Fresh Program®)?
The BioCorRx Recovery Program is an outpatient medication-assisted treatment (MAT) program for alcohol and opioid drug addiction. The comprehensive program is comprised of two parts: (1) an implant, of a proprietary compounded formulation of the non-addictive medication, naltrexone. The naltrexone implant, which is prescribed by a licensed physician and implanted under the skin, can reduce the cravings for opioids and alcohol, and block opioid euphoric effect, over an extended period of time and (2) uniquely and specifically structured, intensive one-on-one addiction counseling program developed by BioCorRx, Inc.® (the “Counseling Program”).
What is naltrexone?
Naltrexone is an FDA approved medicine that serves as an opioid receptor antagonist. It is used primarily in the treatment of alcohol and opioid dependence. Naltrexone blocks certain receptors in the part of the brain that trigger dopamine release and reinforces the vicious and compulsive addiction feedback loop. When these areas of the brain are blocked, the craving for alcohol and opioids is eliminated or significantly reduced. And if alcohol is consumed, the pleasure is very limited and the uncontrollable cascade of relapse is much less likely. If opioids are used, it can block their effects.
Why is the elimination of cravings important? The freedom from the physical cravings for alcohol and drugs is critical. By removing the intrusive compulsion to drink or use, patients can refocus on their life, their relationships, their family, and the long term psychosocial-behavioral aspect of the recovery. It is of particular importance during the first six months of recovery.
Is the naltrexone implant FDA approved?
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 properly credentialed medical provider (MD, PA, DO or NP) who has determined that his or her patient is a good candidate for the implant. Only a licensed medical provider can insert the implant into a patient who consents to this treatment option. Regulations may vary by state in regards to what medical credentials are required to prescribe and/or insert the implant.
The implant is a specially compounded, implantable formulation of naltrexone that is made specifically for each individual program participant only after a prescription is written by a 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.
Explain what a compounded formulation is.
Have any clinical trials been conducted on the BioCorRx® Recovery Program?
No. There have been no clinical trials testing the efficacy of the BioCorRx® Recovery Program. There may be clinical trials in the future.
Is naltrexone addictive?
Naltrexone is not addictive, and there is no physical dependence. It does not produce a “high” or any feelings or sensations that could be considered pleasurable or addictive. In addition, there is no physical withdrawal or evidence of rebound drinking or using when naltrexone wears off or is discontinued.
Does naltrexone cure alcoholism or opioid addiction?
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.
Why have I not heard of medicines available to assist alcoholics and addicts in their struggle?
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.
What are the common side effects of naltrexone?
Naltrexone has proven record of safety. It is a very safe and well tolerated medicine. The most common side effects of naltrexone, that occur in the minority of patients are nausea, diarrhea, headache, dizziness, fatigue, insomnia and anxiety. If present, most side effects are mild and self-limiting. Often, it is difficult to determine whether the symptoms are true side effects, or a result of the body’s detoxification from chronic alcohol and drug dependence. Although exquisitely rare, in supra-therapeutic doses on pre-disposed individuals. Naltrexone has been noted to have inflammatory effects on the liver, so routine blood testing of liver function should be performed prior to treatment. Uncommonly, program participants may report depression or exacerbation of pre-existing mood disorders including suicidal ideation. For a more detailed report on side effects of naltrexone, click here.
What are the potential complications from receiving a naltrexone implant?
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 a 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.
How does naltrexone react with other medications?
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.
Can I just take the oral form of naltrexone?
Yes, you can. Naltrexone in the oral or injectable form does work, but there are distinct advantages to receiving a naltrexone implant. The implant releases a slow and steady dose of naltrexone into the body over many months resulting in consistent drug levels and long lasting effective suppression of the cravings and opioid effectiveness. There are significantly fewer fluctuations in the drug levels, which tends to maintain a more reliable and steady suppression of the cravings. Most importantly, having the implant removes the critical issue of daily medication compliance typically seen in most program participants dealing with addiction. When taking naltrexone orally a program participant often skips a dose or sleeps in too late, or forgets to pack the medication on travel or may be unable to get a refill, or more commonly, may be deceived into believing that they are now in control and no longer require the medicine. Each of these scenarios illustrate how medication non-compliance often leads to relapse.
What if I’m addicted to opioids (often referred to as Opiates), can I receive the implant?
Yes. Naltrexone is FDA approved for the treatment of opioid addiction but there are additional considerations that must be made. Opioid recovery should be managed by a medical caregiver who has training and experience in treating opioid addiction. The naltrexone implant used in the BioCorRx Recovery Program has been used successfully for many years by doctors in Australia to treat opioid addiction. BioCorRx does not render medical advice or make medical decisions in this regard. An independent prescribing doctor may deem he long-lasting compounded naltrexone implant as a safe and appropriate treatment for his patient in opioid recovery. Most doctors require that patients be at least 7 to 10 days opioid-free before receiving any type of naltrexone treatment. Please speak to a licensed physician about naltrexone use to opioid addiction treatment. There are associated risks if you attempt to abuse narcotics while on naltrexone. There is a life threatening risk of overdose if you attempt to overcome the antagonist properties of naltrexone. Furthermore, tolerance is dramatically lower after just a short time of opioid abstinence, so once the naltrexone implant has dissolved and is no longer providing effective levels in the serum, there is significantly higher risk of fatal drug overdose if relapse.
Why is the one-on-one intensive counseling program necessary?
The BioCorRx® Recovery Program is comprehensive, so as to provide each 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. This is strongly discouraged. 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.
Do we support AA and NA?
Absolutely! We have no association or affiliation with AA or other similar support groups, but our ultimate goal is simply to help as many individuals as possible become sober and maintain sobriety. We want program participants to be emancipated from the misery of their addiction and be able to realize and fully manifest their potential. We want to assist in giving them back their life. AA is a firmly established and successful organization that we support. It teaches a manner of living that can benefit anybody and establishes a mechanism that the alcoholic can support and help others with a similar struggle. It serves as a safe place to be constantly reminded of the risk of relapse, and provides additional tools and support to maintain long term sobriety. The benefit of fellowship and camaraderie of a group support in recovery cannot be overstated. We do not consider our program in conflict with AA. In fact, we believe that our program will assist AA, or any support group or recovery program in achieving lasting success with a higher percentage of their participants. We recognize that many people in the throes of addiction are incapable of concentrating and absorbing the teaching of counselors, therapists, and group meetings. And no matter how hard they try, some individuals are unsuccessful in the “white knuckle” approach. In addition, every person and every recovery journey is different and many individuals simply don’t thrive in the group setting. By eliminating the intrusive and overwhelming craving to drink, we find that program participants are better able to ingest, digest, and apply the teachings from their counselors, therapists, AA, alternative 12-step program, SMART recovery, or wherever they feel most comfortable so as to maintain long term sobriety.