OPEN Foundation

P. Wolfson

MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

Abstract

The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, – 23.5 (13.2), indicating less anxiety, compared to placebo group, – 8.8 (14.7); results did not reach a significant group difference (p = .056). Hedges’ g between-group effect size was 1.03 (95% CI: – 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety.Trial Registration: clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.

Wolfson, P. E., Andries, J., Feduccia, A. A., Jerome, L., Wang, J. B., Williams, E., Carlin, S. C., Sola, E., Hamilton, S., Yazar-Klosinski, B., Emerson, A., Mithoefer, M. C., & 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. https://doi.org/10.1038/s41598-020-75706-1

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High-dose ketamine infusion for the treatment of posttraumatic stress disorder in combat veterans.

Abstract

INTRODUCTION:
Combat veterans are at high risk for the development of posttraumatic stress disorder (PTSD) and substance use disorders. Ketamine has been shown to be an effective treatment for numerous mental health disorders, although research on its efficacy in combat-related PTSD in veterans is very limited.
METHODS:
The study population consisted of 30 US military veterans with combat-related PTSD. Participants underwent a standard induction series of six 1-hour ketamine infusions with the goal of obtaining a transpersonal dissociative experience. Participants were given a series of self-report questionnaires to assess for changes in symptoms of depression, PTSD, and substance use prior to the first and sixth infusions.
RESULTS:
Symptoms of depression as measured by change in score on the Patient Health Questionnaire decreased significantly from an average of 18.9 to 9.5 (P < .001). Similarly, symptoms of PTSD as measured by change in score on the PSTD Checklist for DSM-5 dropped significantly from an average of 56.2 to 31.3 (P < .001). Self-reported levels of substance use did not significantly decrease during the study period, although the level of use trended down.
CONCLUSIONS:
This observational study suggests that high-dose ketamine infusion therapy, which induced a transpersonal dissociative experience, could be a valuable tool in the treatment of combat-related PTSD. Further study is needed to better elucidate ketamine’s mechanism of action with regards to the treatment of PTSD.
Ross, C., Jain, R., Bonnett, C. J., & Wolfson, P. (2019). High-dose ketamine infusion for the treatment of posttraumatic stress disorder in combat veterans. Annals of clinical psychiatry: official journal of the American Academy of Clinical Psychiatrists31(4), 271-279., https://www.ncbi.nlm.nih.gov/pubmed/31675388
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IJTS Special Topic Section: Ketamine ● The Transformative Power of Ketamine: Psychedelic States and a Personal History of Transformation

Abstract

A discussion of the nature of transformation and its relationship to psychedelic experiences— particularly ketamine experiences—is presented and discussed along with a schema for thinking about types of states that may be encountered and transformations that may occur related to psychedelic use and practice. This is followed by a longitudinal historical approach for portraying and examining personal transformation along with a proposed instrument— The Transformational Codex—for cataloging that history and the elements that compose it.

Wolfson, P. E. (2014). The Transformative Power of Ketamine: Psychedelic States and a Personal History of Transformation. International Journal of Transpersonal Studies, 33(2).
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IJTS Special Topic Section: Ketamine ● Ketamine (IM) Assisted Psychotherapy (KAP): A Model for Informed Consent

Abstract

Informed consent is important for every medical intervention, and the unique nature of ketamine assisted psychotherapy (KAP) calls for a particularly thoughtful and detailed informed consent document. The following is an informed consent form developed for the author’s use in his own private practice. No representations are made concerning its adequacy or appropriateness for use by other practitioners, or in any other contexts; author, editors, and publisher disclaim liability for any use of or reliance on this document. However, as a document created by a psychiatrist with experience in KAP, this form may serve to illustrate the range of issues that an informed consent document might address.

Wolfson, P. E. (2015). Ketamine (IM) Assisted Psychotherapy (KAP): A Model for Informed Consent. International Journal of Transpersonal Studies.
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IJTS Special Topic Section: Ketamine ● Ethnographic Accounts of Ketamine Explorations in Psychedelic Culture

Abstract

Off-label use of ketamine as a mind-altering substance did not begin in the laboratory, but in the psychedelic culture that grew out of the 1960s counterculture movement. Whatever the risks and limitations of such experimentation, without them the remarkable therapeutic effects of the drug might well have gone unnoticed, and unresearched. The following personal accounts—both inspiring and cautionary—offer glimpses into the cultural contexts that found ketamine to be much more than a reliable anesthetic.

Ring, K., Metzner, R., & Wolfson, P. E. (2014). Ethnographic Accounts of Ketamine Explorations in Psychedelic Culture. International Journal of Transpersonal Studies, 33(2).
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IJTS Special Topic Section: Ketamine ● Psychedelic Experiential Pharmacology: Pioneering Clinical Explorations with Salvador Roquet

Abstract

Richard Yensen was a research fellow at the Maryland Psychiatric Research Center from 1972 to 1976. He studied psychedelic psychotherapy with Stanislav Grof, M.D. and other senior staff. During this time he treated patients with substance abuse disorders, cancer, neurosis, and other health professionals seeking a training experience. Dr. Yensen did his Ph.D. dissertation on the use of MDA in psychotherapy with neurotic outpatients and conducted his research at the MPRC. Through many years of experience in governmentsanctioned psychedelic research, he has evolved a non-drug shamanistic psychotherapy called Perceptual Affective Therapy. In the 1990’s Richard was co-holder of IND 3250, an investigational new drug permit issued by the U.S. Food and Drug Administration to study LSD and psychotherapy until 2006. He is currently a licensed psychologist in California and director of the Orenda Institute in Vancouver and Cortes Island, British Columbia, Canada and president of the Salvador Roquet Psychosynthesis Association. He has served on the faculties of Harvard Medical School, Johns Hopkins University and the University of Maryland Medical School in Baltimore.

Wolfson, P. E. (2015). Psychedelic Experiential Pharmacology: Pioneering Clinical Explorations with Salvador Roquet. International Journal of Transpersonal Studies.
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IJTS Special Topic Section: Ketamine ● Ketamine for Depression: A Mixed-Methods Study

Abstract

Prior studies have reported variously on the presence or absence of dissociative effects at subanesthtetic doses of ketamine administered for treatment-resistant depression. This mixedmethods study emulated the protocol used for the studies in question, with IV administration of 0.5mg/kg over 40 minutes with eight experienced ketamine users. Quantitative measures were generally insignificant since this was not a population reporting depression; blood pressure increased as expected by 20-30mm systolic and 6-20mm diastolic, falling rapidly by 20 minutes after completion of the infusion. Individual qualitative reports reports of relaxation, pleasant sensation, decreased cognitive function, and some disabling of ordinary capacities. As experienced users, subjects commented freely on what was characterized as the triviality of the experience, and typically expressed skepticism that ketamine could have antidepressant properties when administered at this dose or in this manner, as well as disbelief that it could be beneficial except perhaps as a period of relaxation, or as a partial break from ordinary states of mind in naïve subjects. Group discussion produced a consensus recommendation in favor of threshold- and higher-dosage transformative work beginning with a 40-50mg IM bolus, potentially in a series of sessions with higher dosages if indicated, with the number of sessions to be determined by clinical practice; such work should occur in a closely monitored psychotherapeutic setting.

Wolfson, P. E. (2014). Ketamine for Depression: A Mixed-Methods Study. International Journal of Transpersonal Studies, 33(2).
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IJTS Special Topic Section: Ketamine ● Ketamine—Its History, Uses, Pharmacology, Therapeutic Practice, and an Exploration of its Potential as a Novel Treatment for Depression

Introduction

The origins of this special section on ketamine and ketamine assisted psychotherapy and an overview and deliberately controversial discussion of depression and ketamine’s putative efficacy as an antidepressant arise from two sources. The first is a fairly widespread and historical appreciation of ketamine’s power as a transformative agent, especially when embedded in a psychotherapeutic context. Ketamine is after all the only legal psychedelic in use—as a Schedule III substance with an indication as a dissociative anesthetic and a long history of safe and effective use for anesthesia and analgesia, this without significant respiratory depression. Other uses have occurred, for example in the control of agitated, suicidal, and aggressively psychotic individuals in the ER setting, and as a transformational, psychedelic experience at low to moderate dosages—pre-anesthetic levels — inspired by the work of Roquet, Jansen, Krupitsky, and others [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][…]

Wolfson, P.E. (2014). Introduction to the Special Topic Section: Ketamine–Its History, Uses, Pharmacology, Therapeutic Practice, and an Exploration of its Potential as a Novel Treatment for Depression. The International Journal of Transpersonal Studies, 33(2), 33-39.
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