Mindbloom for Habit Change

Mindbloom pairs individuals with licensed clinicians who are trained to diagnose and treat anxiety, depression, and other mental health conditions.  If one of the licensed clinicians, in their medical judgment, decides that ketamine is an appropriate treatment for an individual based on a clinical assessment, then the clinician may prescribe ketamine tablets that are compounded by pharmacies under Section 503A of the federal Food, Drug, and Cosmetic Act (FDCA).  Drugs compounded under Section 503A do not require FDA approval, and as such the FDA has not determined that the compounded ketamine prescribed is safe and effective for anxiety, depression, or other mental health conditions.  The use of ketamine for anxiety, depression, and many other mental health conditions, however, is supported by a body of scientific literature.  (Data on file).

Ketamine is a Schedule III controlled substance. Other drugs containing ketamine, which (unlike compounded drugs) are subject to FDA’s approval requirements, have been FDA-approved as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia. However, those drugs have not been FDA-approved for anxiety, depression, or other mental health conditions, and they have not been FDA-approved in tablet form. The approved label is available here.

Ketamine may cause serious side effects, including but not limited to risks of: sedation; dissociation; psychiatric events or worsening of psychiatric disorders, including problems in people with schizophrenia, severe personality disorders, or other serious mental disorders; dependence, abuse and misuse; anxiety; increases in blood pressure or heart rate; respiratory depression (breathing becomes slower and shallower and the lungs fail to exchange carbon dioxide and oxygen efficiently); lower urinary tract and bladder symptoms, including frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size; altered sense of time; dry mouth; elevated intraocular or intracranial pressure; loss of appetite; confusion; nausea/vomiting; blurred vision; and slurred speech.

The FDA has advised that at-home administration of compounded ketamine may present additional risks because a health care provider is not available onsite to monitor for adverse outcomes resulting from sedation and dissociation.

Mindbloom’s protocols and guidance have been designed to minimize the likelihood of experiencing these side effects or other adverse effects, and should be followed carefully. Ketamine should only be taken as directed by the treating clinician.

Do not proceed with ketamine treatment if any of the following apply to you:

• Allergic to ketamine
• Symptoms of psychosis or mania
• Uncontrolled high blood pressure
• CHF or other serious heart problem
• Severe breathing problem
• History of elevated intraocular or intracranial pressure
• History of hyperthyroidism
• Other serious medical illness
• Pregnant, nursing, or trying to become pregnant

Ketamine has been found to cause moderate psychological dependency in some users.

• In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
• Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders
• Users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your clinician before proceeding with treatment
• The dissociative effects of ketamine may increase patient vulnerability and the risk of accidents

To promote positive outcomes and ensure safety, follow these ketamine treatment guidelines:

• Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep
• Refrain from taking benzodiazepines or stimulants for 24 hours prior to treatment
• Continue to take antihypertensive medication as prescribed
• Do not take ketamine while hungover or with alcoholic beverages
• Refrain from consuming solid foods within 3 hours prior to treatment and liquids within 1 hour prior to treatment
• Ketamine treatment should never be conducted without a peer treatment monitor physically present

A peer-reviewed study of Mindbloom’s client treatment outcomes was published in the Journal of Affective Disorders in 2022, titled At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial. The FDA has not evaluated head-to-head trials comparing the safety of ketamine to other medications that are FDA-approved for the treatment of depression, anxiety, or other psychiatric disorders. Although some clients report that they had more success with ketamine than with FDA-approved therapies, these outcomes may not be typical.

For more information about the informed consent that clients review and sign prior to treatment, please visit mindbloom.com/informed-consent.