Oral Ketamine Instructions and Consent
Consent form required prior to treatment.
Consent to Treatment:
I, the undersigned, hereby provide my informed consent to undergo oral Ketamine treatment with accompanying therapy sessions. I have been informed of the risks, benefits, evidence, and alternatives associated with this treatment.
Purpose and Benefits:
Ketamine treatment, combined with therapy sessions, may be utilized for the treatment of various mental health conditions, including but not limited to depression, anxiety, and post-traumatic stress disorder (PTSD). The potential benefits may include rapid relief from symptoms and improvement in overall mental well-being. Ketamine teaches you to let go of thought patterns and negative behaviors that no longer suit you.
History and Mechanism:
Ketamine, originally developed as an anesthetic, has gained attention for its potential therapeutic effects on mental health. Research suggests that ketamine may positively impact individuals with treatment-resistant depression, anxiety, and PTSD. Ketamine's mechanism of action involves the modulation of neurotransmitters like glutamate, which plays a role in mood regulation and cognition. Ketamine can influence cognitive processes, temporarily altering thought patterns and reasoning abilities, inducing a profound state akin to deep meditation. Within this altered state, individuals may experience a heightened sense of spirituality and an openness to profound spiritual feelings.
Expectations and Mental/Psychological Effects:
During the treatment, one may experience altered perceptions, emotions, and thoughts. Some individuals may undergo a dissociative state, where they feel detached from their surroundings or body. It's important to understand that these effects are temporary and will subside after the treatment. The treatment may surface underlying emotional trauma, allowing for potential healing and relief from associated psychological distress.
Preparation and Working Through Negative Experiences:
Prior to the session, proper preparation is vital. This should include discussions with your healthcare provider and mental health professional about fears, concerns, and past trauma. Learning relaxation techniques, deep breathing, and mindfulness practices can be beneficial in managing any anxiety or negative experiences that may arise during the treatment. If negative emotions emerge, working through them during the treatment and afterwards with a mental health professional in subsequent therapy sessions is crucial.
Pre-session and Post Integration Counseling:
I acknowledge the importance of pre-session counseling to discuss expectations, potential effects, and any concerns I may have about the therapy. Post-treatment therapy and integration counseling will allow me to process and make sense of my experiences, facilitating emotional healing and growth. I am committed to engaging in both pre- and post-session counseling and will continue treatment with my psychiatrist and/or therapist.
Journaling, Recording Experiences, and Seeking Support:
I understand the value of journaling or recording my experiences during and after the treatment. This can aid in reflecting on my journey, identifying patterns, and tracking my progress. Additionally, I am encouraged to speak openly with my support systems, including close friends, family, and therapists, to enhance my healing process.
Medications and Food Precautions:
I agree to stop certain medications, particularly sedatives, as advised by my healthcare provider, at least 6 hours before the treatment. I will also refrain from consuming food for 6 hours prior to the treatment. I will continue taking blood pressure and other vital medications with a small sip of water.
Set and Setting:
I understand the significance of a safe and supportive environment during the treatment. I will ensure a comfortable, quiet, and calming setting for the treatment, where I feel safe and at ease. I will ensure a calm and relaxed mindset prior to initiation of treatment and I will set an intention before starting the therapy. I will prepare a playlist of relaxing or uplifting music that will accompany me on my journey. I will have a trusted close friend or guide present during the treatment session to provide emotional support and assistance if needed.
Pharmacology and Administration:
Oral Ketamine is designed for sublingual administration. When placed in the mouth, the tablet dissolves and is absorbed through the mucous membranes. The active ingredient, ketamine, is rapidly absorbed into the bloodstream, allowing for efficient delivery of the medication and a quicker onset of effects compared to traditional oral tablets. The drug converts to norketamine, crosses the blood brain barrier, and antagonizes or blocks the N-methyl-D-aspart (NMDA) glutamate receptors in the central nervous system, inhibiting activity of the excitatory neurons and producing dissociative analgesia and sedation. Rapid clearance of the drug occurs via Cytochrome P450 metabolism pathways in the liver with a half-life of 2.5 hours.
Oral Administration Technique:
To administer the medication, I will place the oral dissolving tablet in my mouth, allowing it to dissolve slowly and be absorbed through the lining of the mouth. It's important not to swallow the tablet for 10-15 minutes to maximize absorption through the mucous membranes. After this period, any remaining residue can be swallowed.
Onset, Peak, and Duration of Action:
Following oral administration, the onset of action of oral ketamine typically occurs within 10-30 minutes. The medication reaches its peak effect within 1 to 2 hours, during which time I may experience the therapeutic effects. The duration of the therapeutic effects can vary but typically lasts around 3-4 hours. Depression and anxiety symptom relief is rapid and the benefits can last for weeks.
Physical Sensations and Feelings:
After the initial period of relaxation, I may begin to experience a sense of mental clarity, a shift in mood, and a potential reduction in distressing thoughts or emotions. Some individuals describe a feeling of lightness or dissociation from negative feelings. It's important to remain in a comfortable, safe environment during this time to fully experience and integrate the effects of the medication. All thoughts may cease and you may enter a deep meditative and blissful space.
Monitoring and Safety:
Safety is of paramount importance during the oral ketamine treatment. To ensure my physical well-being, I will remain in bed throughout the duration of the experience. If the need to move or leave the bed arises, I will seek assistance from a trusted individual present to ensure my safety. It's important to avoid any activities that may pose a risk, such as driving, operating heavy machinery, or engaging in activities that require high levels of coordination or alertness. I acknowledge the importance of monitoring vital signs during and after the administration of ketamine. This may include regular checks of blood pressure, heart rate, and oxygen saturation.
Risks and Side Effects:
I understand that the use of ketamine treatment carries potential risks and side effects, which may include but are not limited to:
- Dizziness or lightheadedness, blurred vision, unsteady gait, imbalance
- Nausea or vomiting
- Increased heart rate or blood pressure
- Changes or decreases in perception or sensation, sense of time
- Psychological discomfort or dissociation, vivid dreams
- Confusion and agitation, restlessness and slurred speech
- Laryngospasm, respiratory depression or apnea
- Frequent urination, incontinence, hematuria, or dysuria
- Increase intraocular pressure and nystagmus
- Potential for addiction or misuse (rare when protocol followed)
Side effects are usually mild and temporary, occurring in a relatively small percentage of cases and tend to wear off spontaneously as the drug is metabolized. Serious adverse effects such as severe confusion, or difficulty breathing are rare but warrant immediate medical attention.
Drug Interactions and Medications to Avoid:
Ketamine may interact with other medications, potentially affecting its effectiveness or increasing the risk of side effects. It's important to inform my healthcare provider about all medications, supplements, and herbal products I am currently taking. Specifically, I should avoid sedatives such as benzodiazepines, opiates, alcohol, and any other substances that depress the central nervous system during the treatment, as they can intensify the sedative effects of ketamine. Combining ketamine with monoamine oxidase inhibitors (MAOIs) may also lead to serious complications and should be avoided.
Contraindications to Therapy:
Contraindications to ketamine treatment include a history of significant cardiovascular conditions, such as uncontrolled hypertension, severe heart disease, or recent myocardial infarction. Severe breathing problems such as uncontrolled asthma or COPD. Additionally, the presence of acute or uncontrolled psychiatric conditions, such as psychosis or active substance abuse, may preclude one from undergoing this therapy. Individuals with a history of allergic reactions to ketamine or its components should also avoid this treatment. Pregnant or breastfeeding individuals, as well as those with a history of bladder or urinary tract issues, should consult with their healthcare provider to evaluate the potential risks and benefits before considering ketamine treatment.
Experimental Nature of Treatment:
I acknowledge and understand that ketamine is an experimental treatment and its full range of effects, potential benefits, and risks may not be fully known. I have been informed that this treatment is not considered a standard first-line treatment for my condition and is being explored as an alternative or adjunctive option after having failed traditional therapy modalities.
Adherence to Guidelines:
I agree to follow all guidelines and instructions provided by my healthcare provider regarding the administration, dosage, and timing of ketamine treatment. I understand that adherence to these guidelines is crucial for my safety and the effectiveness of the treatment. I understand the importance of responsible medication use and commit to taking only the prescribed dose of ketamine as directed by my healthcare provider. I will not increase the dose or frequency of administration without first discussing it with my physician. This treatment is for me alone and I will not share any of the ketamine with anyone else.
Continuing Communication:
I commit to maintaining open communication with my healthcare provider regarding any changes in my medical condition, medications, or potential adverse effects experienced during or after the treatment. I will promptly report any concerning symptoms or reactions.
Consent to Discontinue Treatment:
I understand that I have the right to discontinue oral ketamine treatment at any time, for any reason, and without any penalties. I will inform my healthcare provider if I choose to discontinue the treatment.
Liability Release:
I, the undersigned, acknowledge that oral Ketamine treatment involves potential risks and benefits as outlined in this consent form. I understand that while Dr. Benjamin Soffer will exercise utmost care and professional judgment during the course of my treatment, there are inherent risks associated with any medical intervention. In consideration of the potential benefits, I voluntarily release and discharge Dr. Benjamin Soffer and any associated healthcare professionals or facilities from any liability or responsibility for adverse effects, consequences, or outcomes that may result from the administration of ketamine treatment.
I have had the opportunity to ask questions and discuss any concerns I may have regarding the ketamine treatment, and all my questions have been answered to my satisfaction. I have read this entire document and understand all of the information discussed above.
Patient Name and Signature