CONSENT FOR NALTREXONE MAINTENANCE THERAPY WITH Pellet Injection

The NaltrexZone

This document confirms our conversations concerning your medical problems. The following are some of the items discussed with you. This list is not inclusive of all items or factors discussed or related to your medical problem including the procedure to be performed.

PATIENT:__________________AGE:_______DATE:_________

1 . HOW NALTREXONE WORKS

I hereby authorized The NaltrexZone as designated to perform a procedure known as naltrexone maintenance therapy (therapy) including the implantation of the depot-naltrexone pellet (pellet).

By signing this form, I agree to the have a pellet injectioned in my body. Naltrexone blocks the effects of opiates, such as heroin. Naltrexone is not a cure for my addiction. If you have used opiates within the last week, you will go into withdrawal from the pellet.

If you use opiates while on naltrexone, nothing will happen unless the naltrexone wears off. Of course, for your treatment for addiction to be effective, you will need to go to support meetings such as a 12-Step Recovery Program.

During the therapy, a pellet which contains naltrexone will be inserted under the skin. The naltrexone is expected to be released from the pellet over time. This will prolong the opiate blocking condition. The effect of the pellet lasts approximately 60 days. I agree that the pellet should not be removed from my body by myself. If I experience any problems with the pellet I have been advised to contact The NaltrexZone. The NaltrexZone is not required to remove the pellet unless it is medically indicated.

Naltrexone is a medically accepted Food and Drug Administration (FDA) approved drug for the treatment of drug addiction and alcoholism. Furthermore, the implantation method is a medically accepted method of administering many drugs. However, implanting naltrexone under the skin is a new way to deliver naltrexone.

Naltrexone has not been approved by the FDA for use in pellets. The naltrexone used in the pellet will be compounded by a pharmacy. It will not come from a drug manufacturer.

The alternative to this method of treatment is to take naltrexone orally. Naltrexone has been approved by the FDA for this use and has been widely used for this purpose. This involves taking one pill each day.

The benefit of the pellet is that it will release the naltrexone over a long period of time. This means that you will not need to take naltrexone orally each day while the implant is active (which may be up to 60 days or more).

If I use opiates while on naltrexone, I will experience no euphoria unless the naltrexone wears off. If I start using heroin again, I understand I could die if I took my usual dose of heroin right away.

2. PELLET INJECTION

The implant will be inserted under the skin. An antiseptic will be applied first to clean the area. Then, a local anesthetic (Xylocaine) will be given. I understand that I may feel burning when this happens. Then, the pellet will be inserted. Afterwards, the wound will be bandaged.

I have been encouraged to return to The NaltrexZone to check the effect of the pellet, have an additional pellet insertion or to take oral naltrexone (ReVia) to maintain the opiate blocking condition.

3. POSSIBLE RISKS AND SIDE EFFECTS

The risks from the implantation of the pellet include possible infection, soreness, bruising, swelling and scarring at the incision site. In addition, I understand I may also feel some discomfort afterwards at the spot where the pellet was placed. There is also the possibility that the pellet will not be effective for the full 60 days. There is also the risk that the pellet will not work at all. The effectiveness of the pellet can be monitored. Because oral naltrexone has no significant side effects, it is not expected that there will be significant side effects with the pellet. It is possible though, that implanting the pellet will result in new side effects.

I recognize that during the course of the procedure, unforeseen conditions may necessitate additional or different procedures than those explained. I, therefore, further authorize and request that The NaltrexZone perform such procedures as deemed necessary and desirable, including admitting me to a hospital for continued treatments. The authority granted under this paragraph 4 shall extend to remedy conditions that are not known to or could not reasonably be anticipated by the above physicians and medical professionals at the time the therapy is commenced.

I consent to the administration of local, intravenous and/or general anesthetic agents by The NaltrexZone The risk of anesthesia has been explained to me.

I am aware that the practice of Medicine and Surgery is not an exact science and I acknowledge that no guarantees have been made or implied to me as to the results of the procedure or my satisfaction with the results; nor are there any guarantees against unforeseeable and/or unexpected results.

4. FOLLOW UP AND AFTER CARE

I agree to inform The NaltrexZone of any change in my address, and I agree to cooperate with them in my care and comply with their instructions or prescriptions until completely discharged from their care.

I have been provided with written instructions pertaining to the period after the implantation of the pellet.

I understand that in order for my treatment for addiction to be effective, I will need to attend support meetings such as participation in a 12-step recovery program. I understand that I will be contacted for follow up. I understand that The NaltrexZone recommends that I return for a follow up appointment at least once after the therapy.

I have carefully read the foregoing consent for the therapy. This consent form has been explained to me and I have had an opportunity to ask questions concerning it.

I understand and accept the above and hereby authorize The NaltrexZone, to perform the therapy.

 I understand and accept the above and hereby authorize The NaltrexZone and/or their assistants to perform the therapy.

Signed and dated: