Cannabidiol for Early Psychosis

(STEP-PROMOTE Trial)

This trial tests whether cannabidiol (CBD), a compound from the cannabis plant, can reduce early warning signs of psychosis in people at high risk. It also evaluates the safety of CBD for these individuals. Participants will receive either CBD or a placebo (a pill with no active ingredients) to assess differences in symptoms and safety. Individuals who have experienced warning signs of psychosis, such as unusual thoughts or perceptions, may be suitable for the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

The trial requires that you stop taking certain medications, such as antipsychotics at specific doses, valproate, and clobazam, before participating. If you're on these medications, you may need to adjust or stop them under your doctor's guidance before joining the trial.

Research has shown that CBD is generally safe for early psychosis. Studies have found that CBD can reduce symptoms in people with schizophrenia. Doses between 600 and 1000 mg have produced positive results without major safety issues. Short-term use of CBD has also helped those at high risk of developing psychosis. Importantly, these studies reported that CBD was well-tolerated, with few serious side effects.

Unlike the standard treatments for early psychosis, which often include antipsychotics, Cannabidiol (CBD) is derived from cannabis plants and offers a different approach by potentially modulating brain signaling without the psychoactive effects. Most traditional treatments work by blocking dopamine receptors, but CBD might provide benefits through its unique interaction with the endocannabinoid system, which is thought to influence mood and cognition. Researchers are excited about CBD because it could offer a new option with potentially fewer side effects and a different mechanism of action, providing hope for those who may not respond well to existing medications.

This trial will compare the effects of Cannabidiol (CBD) with a placebo in participants showing early signs of psychosis. Studies have shown that CBD can help reduce symptoms of psychosis. Research suggests that CBD might work as well as some medications used to treat conditions like schizophrenia. In individuals with early signs of psychosis, CBD has shown promise in improving symptoms and may even reduce the need for other medications. Some studies also found that CBD was well-tolerated, causing fewer side effects. Overall, these findings suggest that CBD holds promise for treating psychosis.¹²⁵⁶⁷