THIS INFORMED CONSENT FOR LOW-DOSE NALTREXONE (THE "CONSENT") SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (THE "MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").
This informed consent is for the use of low-dose naltrexone (LDN), a prescription medication used off-label for the treatment of various conditions, including chronic pain, autoimmune diseases, and mental health. The purpose of this consent is to provide you with information about the risks, benefits, and safety considerations associated with LDN treatment in order for you to make an informed decision as to whether or not to proceed with treatment, as well as to obtain your agreement to adhere to the treatment protocol as prescribed by your Medical Group healthcare provider (“Healthcare Provider”). Please read this form carefully and ask any questions you have before signing.
Naltrexone is an FDA-approved medication, FDA approved and used primarily in the treatment and management of alcohol and opioid dependence. It is an opioid agonist, which means that it binds to the opioid receptors in the body to make a person feel like they are receiving an opioid, but without the negative side effects, thereby alleviating cravings and withdrawal symptoms in individuals struggling with opioid addiction and facilitating recovery, promoting sustained abstinence, and reducing the likelihood of relapse and fatal overdose. Low-dose naltrexone has emerged as an off-label use of naltrexone as a treatment option for chronic conditions like pain, autoimmune diseases, and inflammation. LDN works by modulating the immune system and increasing the production of endogenous opioids, which may lead to pain relief and other benefits. In the treatment of alcohol and opioid abuse, the typical dose is 50 to 100 mg. The off-label use of low-dose naltrexone (0.5–6 mg) is not approved by the FDA.
While LDN can potentially improve various health conditions, it may also cause side effects.
Adverse effects are uncommon and generally minor. However, nightmares, vivid dreams or insomnia are possible. Sleep issues and dream states are most often temporary and should subside in days to weeks of using this medication. You must not increase the dose if you are still having these symptoms and should contact your Healthcare Provider.
Other uncommon reactions could include, but are not limited to:
While on LDN you will not get typical pain relief from any opiate analgesic (codeine, morphine, dilaudid, fentanyl, methadone etc.) If you need to take any of these, or if having surgery, you need to discontinue LDN for at least 3 days prior to taking opiate analgesic drugs. You may talk to your doctor about taking aspirin (ASA), Ibuprofen (Advil) or acetaminophen (Tylenol) if you need a pain-reliever. These medications are not affected by LDN.
Low-Dose Naltrexone (LDN) is contraindicated in the following situations:
Your Healthcare Provider will determine the appropriate dosage and titration of LDN based on your specific condition and medical history. Typical full doses range from 3 mg to 4.5 mg daily, depending on the condition being treated. The starting dose is usually lower and gradually increased every 2 weeks as tolerated until the maximum dose is reached. You will take this medication at night before bed.
You understand that all Clinical Services will be provided via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following:
Electronic systems used will incorporate network and software security protocols to protect the confidentiality of customer identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.
Due to state licensure requirements for healthcare providers, you have to physically be in the state that your Healthcare Provider is licensed in during your telehealth visit. By agreeing to this Consent, you are confirming that you will only opt in to care when you are in your state of residence or in one of our locations. Furthermore, you are confirming that your state of residence is one in which the Medical Groups are licensed to treat.
PLEASE NOTE: THE MEDICAL GROUPS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, ARE CONSIDERING HARMING YOURSELF OR OTHERS, OR ARE OTHERWISE IN IMMINENT DANGER, YOU SHOULD DIAL 9-1-1 AND/OR GO TO THE NEAREST EMERGENCY ROOM.
You should seek emergency help or follow-up care when recommended by any healthcare provider or when otherwise needed. You should never discontinue medications or stop a course of treatment without first contacting your primary care provider or other medical professionals for advice. You should not delay treatment or advice from your primary care provider or other medical professionals based on information provided by the Healthcare Provider(s) via the Superpower Platform.
All laws and protections for in-person medical care also apply to telehealth care. This includes confidentiality of information, access to medical records, and sharing of information that could identify you personally. You may decide that you do not want to use the Clinical Services at any time, seek treatment elsewhere and/or with in-person offerings.
Please sign below to acknowledge your understanding and agreement of the following terms in order to proceed with treatment with LDN therapy with a Medical Group Healthcare Provider via the Superpower Platform:
BY SIGNING THIS INFORMED CONSENT, YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDED ABOUT LOW DOSE NALTREXONE (LDN) TREATMENT, INCLUDING THE RISKS, BENEFITS, AND SAFETY CONSIDERATIONS. YOU AGREE TO ADHERE TO THE TREATMENT PROTOCOL AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER AND TO REPORT ANY SEVERE SIDE EFFECTS OR CONCERNS TO YOUR HEALTHCARE PROVIDER PROMPTLY.
Take your medication exactly as directed and written on your prescription label. Use LDN exactly as directed by your Healthcare Provider. Do not use more of it, do not use it more often, and do not use it for a longer time than your Healthcare Provider ordered. By FDA law, this medication is not for resale nor can it be returned for refund. Do not let anyone else take your medication. This medication is intended for use solely by the person for whom it is prescribed and should not be shared with any other individuals. Please follow the directions of your prescribing Healthcare Provider and on your prescription label carefully. If you need further explanation or have questions, please ask your prescribing Healthcare Provider to explain any part you do not understand.
You understand that the Healthcare Provider prescribing LDN holds a professional license issued by the professional licensing board or agency in the state where they practice. You can report a complaint relating to the care provided by contacting the appropriate state professional licensing board.
You acknowledge that there are no guarantees or assurances made with respect to the results of taking the LDN prescribed for you, and there are no guarantees that there will not be side effects and complications.
You understand that LDN may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your prescribing Healthcare Provider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your Medical Group prescribing Healthcare Provider updated as to any changes in your health conditions and history during treatment with LDN, and you agree there shall be no liability on the part of the Medical Groups, the Healthcare Providers or Superpower if you fail to do so.
BY CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE LOW DOSE NALTREXONE TREATMENT THROUGH THIS SERVICE. YOU CERTIFY THAT YOU ARE NOT CONSENTING ON BEHALF OF A MINOR CHILD, AS THIS SERVICE DOES NOT PROVIDE TREATMENT TO INDIVIDUALS UNDER THE AGE OF 18.
MEMBER NAME:___________________________
SIGNATURE:_____________________________
DATE:__________________________________
