Our Commitment to Clinical Safety & Important Safety Information
We understand the power of these sacred medicines.
While psychedelic therapy may be an appropriate option, it is not without risk.
Better U’s medical advisory team and Better U Medical Group continuously collaborates with other world experts and follows growing evidence-based practices to provide affordable psychiatric care for those seeking therapy. There has been a large movement to find medically guided, and evidence-based psychedelic care. We are pleased to see the prioritization of mental health and have worked diligently to safely bridge access to alternative treatments.
Although these healing modalities are ancient in many ways, the psychiatric application is cutting edge. In light of the diverse protocols in the community, here is an overview of how Better U ensures works at every step of our program.
At-Home Ketamine Therapy is not for everyone
We recognize that ketamine therapy is not for everyone. Further, virtually guided protocols require reliable social support and good physical health. Initial screening begins with an online assessment to identify any risk factors and gain insight to whether this treatment is medically appropriate. Patient safety is our absolute priority, and Better U does not extend services to anyone who meets the following criteria:
- Clients younger than 18
- Those pregnant or nursing
- Those struggling with acute substance dependence
- Psychotic disorder or those with history of unaddressed psychotic symptoms
- Bipolar disorder with severe mania
- Unstable medical conditions including but not limited to: hypertension, chronic cardiac disease, aneurysmal vascular disease, respiratory illnesses, seizure disorder, or thyroid disease
- History of intracerebral hemorrhage (brain bleeds), or hypersensity to esketamine, ketamine, or any components (need to have ingredients in compounded product to know whether allergies may exist)
- Moderate to severe liver disease
- History of elevated intraocular or intracranial pressure
- Other serious medical illness
- Those who do not meet the criteria for a psychiatric diagnosis under the current standard of care
In addition to following state and federal guidelines, our clinical criteria follows established evidence-based practices regarding the use of ketamine for psychiatric indications. These standards have been established by the American Psychiatric Association, the American Association of Psychedelics, and the American Psychedelic Practitioner Association.
Better U provides a platform for patients to connect with licensed-clinicians to determine whether ketamine therapy may be appropriate for those with treatment-resistant depression, PTSD and anxiety disorders. We strongly caution against the use of at-home ketamine treatments for those with more serious conditions that include severe bipolar disorder, substance use disorders, eating disorders, and more complicated issues. There are many instances when we may ask for medical clearance from the patient’s ongoing clinician. If our psychiatric providers feel any client is not an appropriate candidate for treatment, the client will receive a full refund and their psychiatric evaluation will be complimentary. *No refunds are available after initial psychiatric appointment as results are may vary and are not guaranteed.
Touch points every step of the way to provide as much support as you need.
Our care coordination team prioritizes education, compassion, safety, and love every step of the treatment journey. After the online assessment, a care coordinator reaches out to confirm medical history and review safety guidelines.
In order to approve treatment, clients meet with their psychiatric provider for an in-depth 30 minute medical and psychiatric evaluation. Our highly trained psychiatric providers follow a comprehensive medical protocol to ensure every qualified patient consistently receives a personalized treatment plan based on their needs. After a step-by-step explanation of the treatment process, education, safety, and therapeutic guidelines, our providers address any patient questions or concerns in order to allow an informed decision about their treatment.
*Better U’s treatment program consists of an initial period of dose acclimation followed by a short term maintenance plan to help propel healing and growth. Patients can check in with their psychiatric provider each month to monitor progress, review health changes, and update prescriptions as necessary. Patients are also encouraged to reach out to the care team at any time with questions or concerns between clinical meetings. All medical questions are relayed to the clinician for response.
In addition to ketamine therapy, our integration guides offer patients access to Better U’s proprietary Neuroplastic Therapy program with personalized routines and guided self-therapy exercises. Our expert medical team also hosts weekly classes to teach about preparation, integration, and various topics around mental health. These sessions provide essential guidance throughout the treatment process to help patients make the most of their treatment.
Education, Safety, and Support are our top priorities.
Better U clinicians carefully verify medical information to ensure relevant factors are considered before writing a prescription. This includes a comprehensive medical history, vital sign monitoring, and assessing psychiatric eligibility. If needed, we will ask for medical clearance or medical records to verify and properly assess fit.
Better U requires all patients to arrange an on-site Peer Support to be available during medical treatments. Peer Support must be an adult (usually a family member, significant other, close friend, or roommate) specified during the intake process and capable of fostering a secure space during ketamine treatments. The Peer Support must review our member portal and provide an attestation that they understand the requirements of the Peer Support role. Patients who cannot arrange for a Peer Support have the option to engage our virtual peer support team to be there for them during treatment.
The Hybrid Model. At home or in-office care, personalized to meet unique needs.
While some circumstances may allow for full telemedical care, our team has built a hybrid approach. For many patients, care begins in the office with their psychiatric provider monitoring the introduction to ketamine therapy. We use a slow taper dosing approach, adopted from evidence-based guidelines. Our clinical team regularly monitors client feedback to make sure dose changes are made when clinically appropriate. For certain patients, we refer them to our local clinic directory where they can receive additional support. SPRAVATO (esketamine) may also be available in-office in select states. For important safety information about SPRAVATO, please see the full prescribing information, including Boxed Warning and Medication Guide.
Our mission: consistently improving as the industry leader in medically guided, evidence-based, access to breakthrough treatments.
Better U’s curated psychedelic therapy protocol combines ketamine sessions (when appropriate) with psychiatric oversight, personalized coaching, educational classes, and integrative care. Our medical protocol is designed to help patients with treatment-resistant depression, anxiety, or PTSD find relief using the latest breakthroughs in holistic mental health care. We aspire to help patients become less reliant on medication and more focused on self-healing, self-growth, self-love, and self-transcendence.Our goal is to help patients achieve this self-improvement with minimal pharmacological intervention, once or twice a week. Our integration guides will continue to provide ongoing emotional support and educational guidance to improve harmony and balance within. Dosing and frequency are tapered down over time as appropriate.
Important Safety Information:
Ketamine can cause serious side effects, including:
- Sedation and dissociation. Ketamine may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Abuse and misuse. There is a risk for abuse and psychological dependence (typically seen in recreational users) with Ketamine treatment. You must inform your Better U clinical provider of any or signs of abuse and dependence before and during treatment with Ketamine.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
Ketamine is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
- How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
- Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- Suicide attempts
- Thoughts about suicide or dying
- Other unusual changes in behavior or mood
Do not take Ketamine if you:
- Have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- Have an abnormal connection between your veins and arteries (arteriovenous malformation)
- Have a history of bleeding in the brain
- Are allergic to esketamine or ketamine
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking Ketamine.
Before you take Ketamine, tell your healthcare provider about all of your medical conditions, including if you:
- Have heart or brain problems, including: high blood pressure (hypertension), slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- History of heart attack
- History of stroke
- Heart valve disease or heart failure
- History of brain injury or any condition where there is increased pressure in the brain
- Have liver problems
- Have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
- Are pregnant or plan to become pregnant. Ketamine may harm your baby. You should not take Ketamine if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with Ketamine.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with Ketamine.
- There is a pregnancy registry for women who are exposed to Ketamine during pregnancy. The purpose of the registry is to collect information about the health of women exposed to Ketamine and their baby. If you become pregnant during treatment with Ketamine, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- Are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Ketamine.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking Ketamine with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking Ketamine?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking Ketamine. Do not take part in these activities until the next day following a restful sleep.
What are the possible side effects of Ketamine?
Ketamine may cause serious side effects including:
- Increased blood pressure. Ketamine can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking Ketamine.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of Ketamine when used along with an antidepressant taken by mouth include:
- Feeling disconnected from yourself, your thoughts, feelings and things around you
- Feeling sleepy
- Spinning sensation
- Decreased feeling of sensitivity (numbness)
- Feeling anxious
- Lack of energy
- Increased blood pressure
- Feeling drunk
- Feeling very happy or excited
If these common side effects occur, they usually happen right after taking Ketamine and go away the same day.
These are not all the possible side effects of Ketamine.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ketamine is not FDA-approved for the treatment of depression or anxiety.
Internal research and data analysis to contribute to the emerging psychedelic industry.
At Better U, we believe that the future of psychedelic medicine require physician collaboration, social enterprise strategies, and a prioritization of patient care over financial gain. This is why we have allocated a large portion of our resources into research studies. We are soon publishing the first ever safety study analyzing the risk profile of our at-home therapy protocol. We plan to share this internal data and conduct IRB studies to advance the acceptance of psychedelic medicine.
A recent study was published around at-home ketamine therapy: