Nature medicine
June 1, 2021
Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al.
965 citations
A phase 3 clinical trial tested MDMA-assisted therapy against placebo for severe PTSD. Participants received manualized therapy with either MDMA or placebo alongside preparatory and integrative sessions. At two months after the last session, the MDMA group showed a significantly greater reduction in PTSD symptoms (average 24.4-point drop on the CAPS-5 scale) compared to the placebo group (13.9-point drop), with a large effect size. Functional impairment also improved more with MDMA. No serious safety issues such as abuse potential, suicidality, or heart rhythm problems were observed. The findings suggest MDMA-assisted therapy is highly effective and safe for severe PTSD, including in people with common co-occurring conditions.
Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer M Mitchell, Michael Bogenschutz, Alia Lilienstein et al.
97 citations
A phase 3 clinical trial tested MDMA-assisted therapy for severe PTSD. In 90 participants randomized to receive either MDMA or placebo alongside therapy, those receiving MDMA showed a significantly larger reduction in PTSD symptoms, with an average decrease of 24.4 points on the CAPS-5 scale compared to 13.9 points in the placebo group. Functional impairment also improved more with MDMA. No serious safety issues like abuse potential or suicidality were observed. The treatment was effective even for patients with common co-occurring conditions such as depression or substance use history. The authors conclude MDMA-assisted therapy is a safe and highly effective treatment for severe PTSD.
Neuropsychobiology
January 1, 2011
Tomáš Páleníček, M. Fujáková, Martin Brunovský et al.
85 citations
Ketamine at behaviorally active doses induces a robust increase in EEG power spectra and coherence in rats. The drug rapidly penetrates the brain, reaching peak concentrations within 15 minutes after administration. Ketamine also produces marked hyperlocomotion and deficits in prepulse inhibition of the acoustic startle reaction, a measure of sensorimotor gating. The maximum levels of EEG change correlate with the kinetics of ketamine, and the effects are most pronounced at 10-15 minutes after administration of 30 mg/kg.
Psychopharmacology
January 1, 2013
Tomáš Páleníček, Michaela Fujáková, Martin Brunovský et al.
51 citations
The synthetic compound 2C-B produces a biphasic effect on movement in rats: initial inhibition followed by excitation, while amphetamine only causes hyperactivity. Both drugs disrupt prepulse inhibition of the acoustic startle reaction, a measure of sensory gating, but have opposite effects on the startle itself. 2C-B increases dopamine and decreases its metabolite DOPAC in the nucleus accumbens, a brain region linked to reward. Low doses of 2C-B reduce electrical brain activity and connectivity; a high dose first decreases then increases brain wave power and connectivity. Increases in theta and alpha brain waves correlate with heightened movement and dopamine levels. These results suggest 2C-B shares properties with hallucinogens, entactogens, and stimulants, and its dopamine effects may indicate psychotomimetic and addictive potential.
Journal of Traumatic Stress
February 19, 2020
Ingmar Gorman, Alexander Belser, Lisa Jerome et al.
43 citations
MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) not only reduces symptoms but also promotes posttraumatic growth (PTG)—positive changes in self-perception, relationships, and life philosophy. Pooled data from three phase 2 clinical trials with 60 participants showed that those receiving active MDMA (75–125 mg) had significantly more PTG and larger reductions in PTSD symptom severity at the primary endpoint compared to the control group (0–40 mg MDMA). At 12-month follow-up, PTG remained higher, symptom severity lower, and two-thirds of participants no longer met PTSD criteria. These large-magnitude effects suggest PTG may be a new mechanism of action for this treatment.
Experimental and Clinical Psychopharmacology
November 27, 2023
Jakub Greń, Ingmar Gorman, Anastasia Ruban et al.
27 citations
Psychedelic integration (PI) refers to practices that aim to minimize harms or maximize benefits after psychedelic use. Although PI is considered essential in psychedelic-assisted therapy, existing models lack empirical support and are not evidence-based. With psychedelic use increasing, the article calls for scientific efforts to develop, examine, and evaluate PI methods. It summarizes current literature, suggests research avenues, and discusses limitations and challenges of PI-focused research.
Psychiatr Res Clin Pract
February 11, 2025
Jules Evans, Marc Aixalà, Brian T. Anderson et al.
18 citations
Thirty psychedelic researchers identified critical gaps in knowledge about harms from psychedelic use, including how to define those harms, predict them, and treat them effectively. They recommend better online information, peer support groups, affordable therapy, and psychiatric consultation for people experiencing post-psychedelic difficulties. The researchers also call for improved funding for a psychedelic safety net, suggesting that psychedelic philanthropists, investors, and companies commit 1% of their investment to support safety measures such as research and support services. The article outlines practical steps to make the field of psychedelic medicine safer.
Journal of psychopharmacology (Oxford, England)
June 10, 2025
Torsten Passie, Anja Loizaga-Velder, Alicia Danforth et al.
4 citations
A consensus-based model curriculum for education and training in substance-assisted psychotherapy (SAP) covers theoretical topics and practical components including apprenticeship observation, ongoing clinical supervision, and self-experience for trainees. The model, developed by authors with extensive SAP experience, also addresses peer and conventional supervision, respect for intercultural differences, and teachings about indigenous use of related substances. It is largely adapted to western industrialized countries with established graduate-level psychotherapy training. The curriculum may be valuable for psychedelic researchers, those training therapists for research studies, and those preparing for clinical work outside research settings.
Curr Top Behav Neurosci
December 10, 2024
Xiaojue Hu, Ingmar Gorman, Elizabeth Nielson
3 citations
Psychedelic Harm Reduction and Integration (PHRI) is a clinical model that combines principles from harm reduction, psychedelic-assisted therapy, mindfulness, and psychodynamic therapy to help clients prepare for and integrate psychedelic experiences without directly administering psychedelics. It uses non-pathologizing, client-empowering strategies, emphasizing non-directive and inner-directed approaches, somatic awareness, and psychological flexibility. The model addresses common integration challenges such as fear, ego dissolution, and increased emotional sensitivity, aiming to translate psychedelic experiences into lasting positive changes while reducing potential harms. The chapter outlines PHRI's theoretical foundations, distinguishes it from other approaches, and explores its clinical application, focusing on the integration phase.
Am J Bioeth
January 13, 2025
Jamie Beachy, Willa Hall, Chantelle Thomas et al.
2 citations
Therapists with extensive clinical experience in MDMA-assisted therapy (MAT) for adults with PTSD in Phase 3 trials offer their perspective in response to a prior article. They draw on their direct work to address points raised, likely clarifying or correcting aspects of MAT's implementation or outcomes. The text indicates their hands-on role in these trials but does not present new findings, data, or a specific argument beyond offering a response based on their experience.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.
Frontiers in Psychology
March 15, 2021
Ingmar Gorman, Ingmar Gorman, Ingmar Gorman et al.
Psychedelic Harm Reduction and Integration (PHRI) is a clinical approach for mental health providers working with patients who use or consider using psychedelics in any setting. It combines harm reduction psychotherapy and psychedelic-assisted psychotherapy, applicable in brief or ongoing therapy. PHRI shifts from focusing only on negative outcomes and abstinence-based addiction treatment toward compassionate, destigmatizing acceptance of patients' choices. The approach addresses assessment, preparation, and managing difficult experiences, responding to increased psychedelic research, media attention, and legal changes.