Articles tagged “clinical-trials”

FDA sets a September 14 public hearing on therapeutic psychedelics and finalizes its first clinical trial guidance for psilocybin, LSD and MDMA.

Phase 3 trial shows Eli Lilly's oral GLP-1 drug orforglipron delivers superior blood sugar control and weight loss compared to oral semaglutide.

Compass Pathways' COMP360 psilocybin therapy could receive FDA approval by late 2026, marking a historic milestone for psychedelic medicine and offering new hope for treatment-resistant depression.

Republican Representative Jaime Green proposes using Michigan's opioid settlement dollars to fund clinical trials of ibogaine, a psychedelic compound showing promise for treating PTSD and addiction in veterans.

Federal researchers receive FDA approval to begin Phase I clinical trial of mitragynine, marking first government-sanctioned human study of kratom's potential therapeutic effects.

The Department of Veterans Affairs begins first government-sponsored study of MDMA-assisted therapy, enrolling 80 veterans in groundbreaking research on psychedelic treatment for co-occurring conditions.

FDA grants Breakthrough Therapy designation to LSD d-tartrate for generalized anxiety disorder, accelerating development of the first LSD-based psychiatric treatment and signaling regulatory openness to psychedelic therapies.

Stanford-led research shows low-dose buprenorphine after ketamine infusion extends anti-suicidal benefits from days to weeks, offering new hope for high-risk patients.

Louisiana legislature moves to authorize state-funded research into ibogaine, psilocybin, and MDMA for treating substance use disorders and PTSD, joining growing national movement.

Clinical trial shows semaglutide plus cognitive behavioral therapy significantly reduces alcohol consumption, offering new hope for treating alcohol use disorder with existing medications.

Ohio's Ibogaine Treatment Study Committee convenes to explore clinical trials for ibogaine-assisted therapy, spurred by Trump's executive order accelerating psychedelic research and veteran advocacy.

University of Alabama at Birmingham study published in JAMA Network Open finds psilocybin-assisted therapy significantly improved abstinence rates among individuals with cocaine use disorder, offering hope for a condition with no FDA-approved medications.

FDA awards priority review vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics for psilocybin and methylone therapies targeting treatment-resistant depression and PTSD.

President Trump signs executive order directing FDA to fast-track psychedelic research, provides $50 million for ibogaine studies, and opens Right to Try pathway for patients with treatment-resistant mental illness.

Intravenous DMT reduced depressive symptoms within a week in Phase IIa trial, with effects lasting up to three months, according to study published in Nature Medicine.

Mississippi, Tennessee, Texas, West Virginia, Oklahoma, and Missouri are coordinating clinical trials of ibogaine—a Schedule I psychedelic—for opioid addiction and PTSD despite federal restrictions.

University of Cincinnati launches one of nation's largest trials pairing weight-loss drugs with proven addiction medication to improve treatment retention and reduce cravings.

University of Pennsylvania researchers develop first brain-targeted gene therapy that mimics morphine's pain relief without triggering reward pathways, offering potential breakthrough for 50 million Americans living with chronic pain.

Oregon and Colorado lead regulated psilocybin therapy programs as research shows promise for depression, PTSD, and addiction. Personal stories reveal profound results.

New Nature Mental Health study finds combining low-dose ketamine with mindfulness training improves outcomes for people receiving buprenorphine treatment, opening door to psychedelic-assisted interventions

First randomized trial testing extended-release buprenorphine in pregnancy finds higher abstinence rates and fewer serious adverse events compared to standard sublingual treatment.

NIH-funded trial finds pregnant patients receiving weekly extended-release buprenorphine injections achieved significantly higher rates of opioid abstinence with fewer serious adverse events than those on sublingual buprenorphine.

New study finds NET Device reduces opioid and stimulant use for 3 months post-treatment, offering hope for polysubstance addiction amid no approved medications for stimulants

University of Arizona trial finds 73% of participants responded to multiple psilocybin sessions, with 40% achieving remission from obsessive-compulsive disorder symptoms lasting six months.

Mississippi Senate passes HB 314, allocating $5M from opioid settlement funds to join Texas and Arizona in FDA clinical trials of ibogaine for opioid addiction and PTSD treatment.

Missouri's Veterans Mental Health Innovation Act would fund FDA ibogaine clinical trials for opioid use disorder and traumatic brain injury, joining Texas and Arizona in breakthrough therapy research.

In a landmark policy shift, the FDA announced it will approve new drugs based on a single rigorous trial plus confirmatory evidence—a change that could accelerate development of therapies for opioid use disorder, alcohol addiction, and stimulant dependence.

Imperial College London study published in Nature finds that a single 30-minute DMT session with therapeutic support reduced depressive symptoms more effectively than placebo, marking another step forward for psychedelic-assisted mental health treatment.