Two new studies on classical psychedelics: Grading the components of ketamine, reducing the psilocybin dose

Awaken’s First Study on Novel S-Ketamine Formulation to Assess Disruptive Effects

Psychedelics Biotech Avakan Life Sciences Corp. AWKNF has initiated an investigational study on the disruptive effect of a proprietary and patent-pending formulation of (S)-ketamine as well as an optimized administration route to support the commercialization of the new drug.

The cohort of the new study will consist of harmful drinkers who will be given a dose of (S)-ketamine via a novel oral thin film formulation.

After dosing, researchers will evaluate the disruptive effects through electroencephalographic (EEG) markers of increased neuroplasticity through participants’ alcohol cravings as well as mechanistic factors.

If results are positive, the partners will potentially sign a global licensing agreement for Phase 1 study data of the patent-pending Oral Thin Film(s)-ketamine formulation. This, in turn, would lead Avakan to advance to a larger Phase 2B study as well as hold global exclusivity rights on the thin film formulation in the treatment of all addictions.

See also: These Are the 11 Biggest Psychedelic News and Trends You May Have Missed Last Year

“This study is really exciting for the future of ketamine-assisted therapy (KAP) in the treatment of alcohol problems. If we find any indication that this new formulation might work in alcohol use disorder (AUD), it could be a great step forward for KAP.” could open it up to a wide range of physicians, therapists and patients,” said the study’s PI. Prof Celia Morgan,

He further comments that the research may eventually help expand this therapy to other indications: “Our previous evidence has shown that ketamine-assisted therapy works in alcohol use disorder, but ketamine needs to be given intravenously.” This may be somewhat limited due to alcoholism. This may then lead to the advent of more widely available new treatments for people with alcohol problems that are not currently being offered by existing treatments.”

Diamond Therapeutics to begin Phase II trial on low-dose psilocybin

Toronto-based psychedelic therapy development company Diamond Therapeutics Inc. received Health Canada approval for a Phase 2 clinical trial evaluating the safety, tolerability and efficacy of repeated low doses of psilocybin for the treatment of generalized anxiety disorder (GAD).

The condition causes people to experience considerable impairment and disability, often concurrently similar to major depression, which is associated with decreased work productivity and increased use of health care services.

Nonetheless, few phase-advanced clinical studies are exploring new treatment options to date.

This randomized, double-blind study will run for four weeks with the potential for an additional four-week open-label extension.

Participants diagnosed with GAD will receive multiple low doses of psilocybin for self-administration on a take-home basis, a considerable innovation within the universe of psychedelic clinical trials.

Diamond CMO Dr. Michael B. McDonnell stated that the following Phase 1 test results For a proven safe, tolerable, non-hallucinogenic range of low psilocybin doses on an outpatient basis, the current Phase 2 trial will explore the effects as well as subjective and cognitive effects on quality of life in adults with GAD.

“We are grateful for Health Canada’s approval of Diamond’s latest clinical trial application, which brings us closer to our goal of developing psilocybin-based drugs that are safe and effective for patients, superior to current first-line , and which can be prescribed on an outpatient basis, eliminating the barrier of long hours spent in a clinic,” said CEO Judy Blumstock.

Photo: Edit Benzinga with photos by Pexels.

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