Phase I of the world’s first clinical trial for dimenthyltryptamine (DMT)-assisted therapy in Major Depressive Disorder (MDD) is now complete. The neuroscience company behind the research, Small Pharma Inc., is sharing the results and analysis of this first phase, and expects to deliver results for Phase II in the first half of 2022.
The Phase I trial involved 32 healthy volunteers who were “psychedelic naïve,” meaning they had no prior use of psychedelic drugs. The volunteers received either four increasing doses of Small Pharma’s SPL026 (DMT Fumarate) compound in combination with psychotherapy, or a placebo. The analysis gave insight into safety and tolerability, as well as treatment experience and subject well-being.
Key findings include:
- In a three-month follow-up, no statistically significant negative effects were identified in regards to anxiety and well-being.
- Data show a clear correlation between quality of psychedelic experience and dosing level.
- There appeared to be a strong connection between levels of DMT in the body and the quality and intensity of the psychedelic experience for the majority of participants.
- IV administration of the drug offers a short-lived, well-tolerated psychedelic experience of ~20 minutes, enabling a dosing session to last only ~30 minutes.
Notably, both patient-reported scores and therapist predictions of expected benefits showed a correlation between the size of the dose and the quality of the psychedelic experience.
No serious adverse events related to the drug occured, and the adverse events that were reported on the day of dosing were minimal and short-lived.The 30 drug-related adverse events noted were mild or moderate and resolved quickly and independently. Testing showed that the drug cleared out of the body quickly, with near undetectable DMT levels in the blood an hour at all investigated doses.
“Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions. The additional insights from Small Pharma’s Phase I study show promising results at this stage of the development,” David Erritzoe of Imperial College London, Chief Investigator of the Phase I/IIa study said in a release. “The dosing time of 30 minutes, in comparison with up to six hours seen with alternative approaches, has the potential to offer a real benefit in terms of treatment regimen for both patients and providers.”
Phase IIa of the study remains on track to deliver results in the first half of 2022. It will involve a blinded, randomized, placebo-controlled, proof-of-concept study of SPLO26, combined with psychotherapy in 42 patients with MDD.
Although it might be a while until DMT receives FDA approval in the United States, the results of this Phase I study shows the promise of this compound potentially being the latest tool to help improve mental health.
Try Ketamine Treatment
If you're ready to explore ketamine treatment for yourself, you can begin the process today through the link below.
This article is for informational purposes only and is not intended to be a substitute for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. If you are in a life-threatening situation, call, text, or chat the National Suicide Prevention Line at 988 or +1 (800) 273-8255, call 911, or go to the nearest emergency room.
Important FDA Safety Information
Ketamine is not FDA-approved for the treatment of depression or anxiety. Learn more about off-label uses here.
Side effects of ketamine treatment may include: altered sense of time, anxiety, blurred vision, diminished ability to see/hear/feel, dry mouth, elevated blood pressure or heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses).
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 reported to produce issues including, but not limited to, those listed below. However, lasting adverse side-effects are rare when medical protocols are carefully followed.
While ketamine has not been shown to be physically addictive, it has been shown to cause moderate psychological dependency in some recreational 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 MindBloom® 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
- Avoid hangovers or alcohol intake
- 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 monitor present to ensure your safety