MDMA Clinical Development
- Mitchell JM, Yazar-Klosinski B, Lilienstein A, Mithoefer M, Nicholas C, Nielson E, Paleos C, Thomas C. (in press). MDMA-Assisted Therapy for Treatment of PTSD. In Aaronson ST, Garcia-Romeu A, Suppes T. (Eds.), Psychedelics: Transforming Psychiatry. The American Psychiatric Association Publishing.
- Mitchell, J. M., Ot'alora G, M., van der Kolk, B., Shannon, S., Bogenschutz, M., Gelfand, Y., Paleos, C., Nicholas, C. R., Quevedo, S., Balliett, B., Hamilton, S., Mithoefer, M., Kleiman, S., Parker-Guilbert, K., Tzarfaty, K., Harrison, C., de Boer, A., Doblin, R., Yazar-Klosinski, B., & MAPP2 Study Collaborator Group (2023). MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine, 29(10), 2473–2480. Author Correction: Nature Medicine 2024 Nov;30(11):3382
- Mitchell J.M., Bogenschutz, M., Lilienstein, A., et al. (2021) MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine. 27(6):1025-1033
- Mitchell, J., Coker, A., & Yazar-Klosinski, B. (2021). Reply to: Caution at psychiatry's psychedelic frontier and Challenges with benchmarking of MDMA-assisted psychotherapy. Nature Medicine. 27(10): 1691–1692
- van der Kolk BA, Wang JB, Yehuda R, Bedrosian L, Coker AR, Harrison C, Mithoefer M, Yazar-Klosinki B, Emerson A, Doblin R. (2024) Effects of MDMA-assisted therapy for PTSD on self-experience. PLoS One. 2024 Jan 10;19(1):e0295926
- Nicholas, C. R., Wang, J. B., Coker, A., Mitchell, J. M., Klaire, S. S., Yazar-Klosinski, B., Emerson, A., Brown, R. T., & Doblin, R. (2022). The effects of MDMA-assisted therapy on alcohol and substance use in a phase 3 trial for treatment of severe PTSD. Drug and Alcohol Dependence, 233: 109356
- Ching, T. H., Williams, M. T., Wang, J. B., Jerome, L., Yazar-Klosinski, B., Emerson, A., & Doblin, R. (2022). MDMA-assisted therapy for posttraumatic stress disorder: A pooled analysis of ethnoracial differences in efficacy and safety from two Phase 2 open-label lead-in trials and a Phase 3 randomized, blinded placebo-controlled trial. Journal of Psychopharmacology, 36(8): 974–986
- Wang, J. B., Lin, J., Bedrosian, L., Coker, A., Jerome, I., Feduccia, A., Lilienstein, A., Harrison, C., Heimler, E., Mithoefer, M., Mithoefer, A., Ot’alora G., M., Poulter, B., Carlin, S., Matthews, R., Yazar-Klosinski, B., Emerson, A., & Doblin, R. (2021). Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder. Journal of Humanistic Psychology, 0(0)
- Ponte L, Jerome, L., Hamilton, S., Mithoefer, M. C., Yazar-Klosinski, B. B., Vermetten, E., & Feduccia, A. A. (2021) Sleep Quality Improvements after MDMA-assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder. J Traumatic Stress. 2021 Aug;34(4):851-863. Epub 2021 Jun 10. Correction published: J Trauma Stress. 2024 Dec 3. doi: 10.1002/jts.23098
- Gorman I, Belser AB, Jerome L, Hennigan C, Shechet B, Hamilton S, Yazar-Klosinski B, Emerson A, Feduccia AA. (2020) Posttraumatic Growth After MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder. Journal of Traumatic Stress. 33(2):161-170. Correction published: J Trauma Stress. 2024 Dec 3. doi: 10.1002/jts.23097
- Feduccia AA, Jerome L, Yazar-Klosinski, Emerson A, Mithoefer MC. (2019) Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-assisted Psychotherapy Compared to Paroxetine and Sertraline. Frontiers in Psychiatry. 10:650
- Ot'alora, G, M., Grigsby, J., Poulter, B., Van Derveer, J. W., Giron, S. G., Jerome, L., Feduccia, A., Hamilton, S., Yazar-Klosinski, B., Emerson, A., Mithoefer, M., Doblin, R. (2018) 3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial. Journal of Psychopharmacology. 32(12):1295-1307
- Mithoefer MC, Mithoefer A, Feduccia A, Jerome L, Wagner M, Wymer J, Holland J, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. (2018) 3-4 methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomized, double-blind, dose-response, phase 2 clinical trial. The Lancet Psychiatry. 5(6): 486-497
- Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Martin SF, Yazar-Klosinski BB, Michel Y, Brewerton TD, Doblin R. (2013) Durability of Improvement in Post-traumatic Stress Disorder Symptoms and Absence of Harmful Effects or Drug Dependency after 3,4- Methylenedioxymethamphetamine-assisted Psychotherapy: A Prospective Long-term Follow-up Study. Journal of Psychopharmacology 27(1):28-39
- Christie, D., Yazar-Klosinski, B., Nosova, E., Kryskow, P., Siu, W., Lessor, D., & Argento, E. (2022). MDMA-assisted therapy is associated with a reduction in chronic pain among people with post-traumatic stress disorder. Frontiers in Psychiatry, 13: 939302
- Wolfson P, Andries J, Feduccia A, Jerome L, Williams E, Carlin S, Sola E, Wang J, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer M, Doblin R. (2020) MDMA-assisted Psychotherapy for Treatment of Anxiety and Other Psychological Distress Related to Life-Threatening Illnesses: A Randomized Pilot Study. Scientific Reports. 10(1): 20442
- Monson CM, Wagner AC, Mithoefer AT, Liebman RE, Feduccia AA, Jerome LI, Yazar-Klosinski B, Emerson A, Doblin R & Mithoefer MC (2020) MDMA-facilitated cognitive-behavioral conjoint therapy for posttraumatic stress disorder: An uncontrolled trial. European Journal of Psychotraumatology. 11(1): 1840123
- Danforth Al, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. (2018) Reduction in Social Anxiety After MDMA-assisted psychotherapy with Autistic Adults: a Randomized, Double-Blind, Placebo-Controlled Pilot Study. Psychopharmacology. 235(11):3137-3148
- Danforth A, Struble CM, Yazar-Klosinski BB, Grob CS. (2016) MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults. Prog Neuropsychopharmacology Biological Psychiatry 64: 237- 249
- Yazar-Klosinski BB, Mithoefer MC. (2017) Potential psychiatric uses for MDMA. Clinical Pharmacology and Therapeutics. 101(2): 194-196
- Jerome L, Schuster S, Yazar-Klosinski BB. (2013) Can MDMA Play a Role in the Treatment of Substance Abuse? Current Drug Abuse Reviews. 6: 54-62
Toxicology & Pharmacology
- Huestis MA, Smith WB, Leonowens C, Blanchard R, Viaccoz A, Spargo E, Miner NB, Yazar-Klosinski B. MDMA pharmacokinetics: A population and physiologically based pharmacokinetics model-informed analysis. CPT Pharmacometrics Syst Pharmacol. 2025 Feb;14(2):376-388
- Cohen, I. V., Barber, L., Dubnicka, T. P., Hurtado, S. B., Tincher, S. A., Stankowski, L. F., Jr, & Yazar-Klosinski, B. (2021). Three regulatory compliant test systems show no signs of MDMA-related genotoxicity. Journal of Psychopharmacology, 35(11): 1431–1434
Chemistry, Manufacturing & Controls
- Nair, J. B., Hakes, L., Yazar-Klosinski, B., & Paisner, K. (2021). Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA. ACS Omega, 7(1): 900–907
Health Economics & Outcomes Research
- Marseille E, Kahn JG, Yazar-Klosinski BB, Doblin R. (2020) The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD. PLoS One. 15(10):e0239997
Epigenetics & Mechanistic Studies
- Lewis, C. R., Tafur, J., Spencer, S., Green, J. M., Harrison, C., Kelmendi, B., Rabin, D. M., Yehuda, R., Yazar-Klosinski, B., & Cahn, B. R. (2023). Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD. Frontiers in Psychiatry, 14: 959590
- Singleton, S. P., Wang, J. B., Mithoefer, M., Hanlon, C., George, M. S., Mithoefer, A., Mithoefer, O., Coker, A. R., Yazar-Klosinski, B., Emerson, A., Doblin, R., & Kuceyeski, A. (2023). Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder. Frontiers in Psychiatry, 13: 947622
- Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, Yazar-Klosinski BB, Doblin R. (2017) Therapeutic effect of increased openness: Investigating mechanism of action of MDMA-assisted psychotherapy. Journal of Psychopharmacology 31(8):967-974
- Blythe AJ, Yazar-Klosinski B, Webster MW, Chen E, Vandevenne M, Bendak K, Mackay JP, Hartzog GA, Vrielink A. (2016) The yeast transcription elongation factor Spt4/5 is a sequence-specific RNA binding protein. Protein Science. 25 (9): 1710-21
Ibogaine Clinical Development
LSD Clinical Development
- Gasser P, Holstein D, Michel Y, Doblin R, Yazar-Klosinski BB, Passie T, Brenneisen R. (2014) Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases Journal of Nervous and Mental Disease. 202 (7): 513-520
Cannabis Clinical Development
- Bonn-Miller MO, Sisley S, Riggs P, Yazar-Klosinski B, Wang JB, Loflin MJE, Shechet B, Hennigan C, Matthews R, Emerson A, Doblin R. (2021) The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial. PLoS One. 16(3):e0246990