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What is Naltrexone?

Naltrexone is a 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 triggers dopamine release and reinforces the vicious and compulsive addiction feedback loop. When these areas of the brain are blocked, the craving for alcohol and opiates 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 opiates are used, they will have no effect.

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, our patients can refocus on their life, their relationships, their family, and the long term psycho-social-behavioral aspect of the recovery. It is of particular importance during the first six months of recovery.

Is Naltrexone FDA approved?

Yes. Naltrexone was FDA approved in the pill form for the treatment of opiate addiction in 1984, and alcohol addiction in 1995.

Explain a compounded formulation.

The implant is a specially compounded, implantable formulation of naltrexone that is made specifically for each individual patient only after a prescription is written by a 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 formulations and/or combinations of FDA approved drugs upon a doctor’s 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 many years. Tens of thousands of patients have successfully undergone treatment.

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 Opiate 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 psycho-social AND physiological malfunctions.  BOTH the physical aspect and the psycho-social/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 psycho-social/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 a miserably controlled diabetic patient and instead only provide intensive nutritional and exercise classes and sessions on how to cook and eat healthier. Those classes and meeting 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 manner as well.

What are the common side effects of Naltrexone?

Naltrexone is a very safe and well tolerated medicine. The most common side effects of naltrexone 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 the body’s detoxification from chronic alcohol dependence. Although exquisitely rare, in supra-therapeutic doses Naltrexone has been noted to have toxic effects on the liver, so routine blood testing of liver function should be performedprior to treatment and periodically during treatment. Uncommonly, patients may report depression or exacerbation of pre-existing mood disorders.

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, patients 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, anti-histamines and topical and/or oral steroidsare 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 patients with acute hepatitis, advanced liver disease, or kidney failure. Pregnant or breast feeding 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 or 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, our patients carry a medical card that may be carried discreetly in one’s wallet or purse. In the event of an emergency that someone requires pain relief due to any medical circumstances, alternative analgesia may be administered in the hospital setting. 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. 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.

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. 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 compliance from these notoriously unreliable and non-compliant patients. If a patient skips a dose, or sleeps in too late, or forgets to pack it on travel, or to get a refill, or more commonly, if they delude themselves into thinking they are now in control and no longer require the medicine, they will be high risk for a relapse.

What if I’m addicted to Opiates, can I have the implant?

Yes and No. Naltrexone is also FDA approved for the treatment of opiate addiction. Patients must be completely off all opiates for 7-10 days prior to beginning Naltrexone therapy. In some cases, Addiction Patch Protocol may assist opiate addicts in their detox. If successfully clear of opiates, the patient would then possibly be a candidate for Naltrexone therapy.

Why is the One-on-One intensive counseling program necessary?

Our program is comprehensive, so as to provide each one of our patients with the highest opportunity for success. In addition to utilizing medicine to address the physical and neuro-biological aspect of the disease, our patients will participate in intensive and individualized one-on-one sessions with our licensed drug and alcohol counselors (most of whom are recovered alcoholics.) As discussed above, to obtain and maintain sobriety, the physical AND the psycho-social/behavioral aspect of addiction must be addressed. The Naltrexone implant is a very effective tool that 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 psycho-social aspect of the addiction. Study after study indicates that medical therapy in combination with counseling is superior to medical therapy alone. It is critical to understand that addiction is a lifelong struggle. Our program has remarkable success in establishing sobriety in the vast majority of our patients. 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.

Do we support AA?

Absolutely! We have no association or affiliation with AA, but our ultimate goal is simply to help as many individuals as possible become sober, and maintain sobriety. We want our patients 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 comaraderie 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 in achieving lasting success with a higher percentage of their participants. We recognize that many people in the throws of the 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 patient, and every recovery, 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 our patients can then ingest, digest, and apply the teachings from their counselors, therapists, AA, alternative 12-step program, or wherever they feel most comfortable with so as to maintain long term sobriety.

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