Cancer patients often develop chronic, clinically significant symptoms of depression and anxiety. Previous studies suggest that psilocybin may decrease depression and anxiety in cancer patients. The effects of psilocybin were studied in 51 cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety. This randomized, double-blind, cross-over trial investigated the effects of a very low (placebo-like) dose (1 or 3 mg/70 kg) vs. a high dose (22 or 30 mg/70 kg) of psilocybin administered in counterbalanced sequence with 5 weeks between sessions and a 6-month follow-up. Instructions to participants and staff minimized expectancy effects. Participants, staff, and community observers rated participant moods, attitudes, and behaviors throughout the study. High-dose psilocybin produced large decreases in clinician- and self-rated measures of depressed mood and anxiety, along with increases in quality of life, life meaning, and optimism, and decreases in death anxiety. At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the high-dose experience, with >80% endorsing moderately or greater increased well-being/life satisfaction. Community observer ratings showed corresponding changes. Mystical-type psilocybin experience on session day mediated the effect of psilocybin dose on therapeutic outcomes.
101: Therapy
Low dose ketamine infusion for comorbid posttraumatic stress disorder and chronic pain: a randomized double-blind clinical trial
Objective: To date, treatment options (i.e. psychotherapy, antidepressant medications) for patients with posttraumatic stress disorder (PTSD), are relatively few, and considering their limited efficacy, novel therapies have gained interest among researchers and treatment providers alike. Among patients with chronic pain (CP) about one third experience comorbid PTSD, which further complicates their already challenging pharmacological regimens. Low dose ketamine infusion has shown promise in PTSD, and in treatment of CP, however they have not been studied in comorbid population and under rigorous control conditions.
Methods: We compared the effects of a single dose of either ketamine (0.5 mg/kg) or ketorolac (15 mg) over a 40-minute of IV infusion in CP patients with and without PTSD, in double blind, randomized study. Measures were collected before, during, one day and seven days after the infusion. A planned sample size of 40 patients randomly assigned to treatment order was estimated to provide 80% power to detect a hypothesized treatment difference after the infusion.Main Outcome and Measures: The primary outcome measures were change in PTSD symptom severity assessed with the Impact of Event Scale-Revised (IES-R) and Visual Analogue Scale (VAS) for pain administered by a study clinician 24 hours post infusion. Secondary outcome measures included Impact of Event Scale-Revised (IES-R), VAS and Brief Pain Inventory (Short Form) for pain 1 week after the infusion.
Results: Both treatments offered comparable improvement of PTSD and CP symptoms that persisted for 7 days after the infusion. Patients with comorbid PTSD and CP experienced less dissociative side effects compared to the CP group. Surprisingly, ketorolac infusion resulted in dissociative symptoms in CP patients only.
Conclusions: This first prospective study comparing effects of subanesthetic ketamine versus ketorolac infusions for comorbid PTSD and CP, suggests that both ketamine and ketorolac might offer meaningful and durable response for both PTSD and CP symptoms.
‘It’s not medical’: Oregon wrestles with how to offer psychedelics outside the health care system
Last month, the Oregon Health Authority issued its first set of draft regulations around training programs for facilitators, setting standards, for example, for the content and hours of training. In the months leading up to these decisions, discussions from advisory board members kept bumping into medical issues, including if it’s possible for licensed mental health professionals to work as practitioners, and to what extent facilitators should ask about a patient’s medical history. National and international psychedelic companies have participated in these conversations.
This psychoactive plant could save lives—and everyone wants to cash in
Iboga plants smuggled out of Gabon provide most of the world’s ibogaine, a drug that can help heal trauma and addiction. As the plant enters fair trade, officials hope regulation ensures equity and sustainability.
I Got a Tour of the First Psychedelic Therapy Clinic in Britain
The CIPPres Clinic in London is all Scandi chic, leafy houseplants and psilocybin trials.
Psychedelic Medicine’s Future Depends on Proactive Development of a Robust Medical Billing and Coding Strategy
Background: Although still investigational, psychedelic therapies appear poised to begin securing regulatory approval as medical treatments in the United States within the next 2 years. If approved, one of the most daunting barriers to equitable patient access to these novel treatments is their incorporation into the medical billing and coding system. Since specific billing codes for psychedelic therapy delivery do not exist, modification of existing codes or development of de novo codes will be necessary. This reality has created uncertainty about reimbursement and the financial future of psychedelic medicine.
Opinion: We argue that development of de novo billing codes in conjunction with the American Medical Association’s Current Procedural Terminology (CPT) Editorial Panel is the best approach for addressing psychedelic therapy reimbursement concerns. However, with no similar existing medical services to guide development, the potential need for multiple providers during dosing sessions, limited mental health care representation on the CPT Editorial Panel, and a number of misconceptions surrounding psychedelic therapy among critics, psychedelic therapy is particularly vulnerable to development of billing codes that undervalue the complexity of its delivery. With an industry-sponsored application for new CPT codes for “psychedelic drug monitoring services” soon to be reviewed by the CPT Editorial Panel, a critical step toward maximizing psychedelic therapy’s societal impact has been taken. However, many questions remain about whether these proposed codes will provide adequate flexibility for a treatment modality involving various drugs, therapeutic approaches, and patient monitoring strategies, as well as which types of providers will qualify to use them. Whether these proposed codes ultimately become the bedrock of billing for psychedelic therapy or future codes are developed to augment or replace them is not known, but it is a promising sign that efforts to create a robust medical billing and coding strategy for psychedelic medicine are now underway.
Personal Psychedelic Use Is Common Among a Sample of Psychedelic Therapists: Implications for Research and Practice
Background: An emerging controversy in psychedelic therapy regards the appropriateness or necessity of psychedelic therapists having personal experience using psychedelics themselves. Although there are a number of potential advantages and disadvantages to personal use among psychedelic therapists, no studies to date have measured their use or other aspects of their training.
Materials and Methods: First, we broadly review the literature on experiential learning in psychotherapy and psychiatry as well as the history of personal use of psychedelics by professionals. We then report on the results of a survey that was sent to all 145 therapists associated with Usona Institute’s Phase II clinical trial of psilocybin for major depressive disorder. Thirty-two of these individuals (22% response rate) participated in the survey.
Results: We found that experiential learning is common in psychotherapy but not in psychiatry, meaning psychedelic therapy straddles two different traditions. In our survey, the majority of psychedelic therapists identified as white, female, and having doctoral degrees. Most of the sample had personal experience with at least one serotonergic psychedelic (28/32; 88%), with psilocybin being most common (26/32; 81%; median number of uses = 2–10; median last use 6–12 months before survey). Participants had myriad intentions for using psychedelics (e.g., personal development, spiritual growth, fun, curiosity). All respondents endorsed favorable views regarding the efficacy of psilocybin therapy.
Conclusion: Personal experience with psychedelics was notably common in this sample of psychedelic therapists, but the study was limited by a low response rate and a lack of diversity among participants. Future research is needed to address these limitations as well as to identify whether personal experience with psychedelics contributes to therapists’ competency or introduces bias to the field. Nonetheless, these findings are the first to delineate the personal use of psychedelics among professionals and can inform a pressing debate for the field.
Psychedelic-assisted therapy is coming — just not to Africa
Last week, the fight against depression received a welcome boost. According to a new study published in Nature, psilocybin, a naturally occurring compound found in over 200 species of fungi, physiologically “rewires” patterns of negative thinking in the brain to alleviate depression.
Do Psychedelics Need Psychiatrists?
As psychedelic drugs are poised to join the mainstream, what is the role of the prescriber?
Investigation of self-treatment with lysergic acid diethylamide and psilocybin mushrooms: Findings from the Global Drug Survey 2020
Background: Growing numbers of people are using psychedelics for personal psychotherapy outside clinical settings, but research on such use is scarce.
Aims: This study investigated the patterns of use, self-reported outcomes and outcome predictors of psychedelic ‘self-treatment’ of mental health conditions or specific worries/concerns in life.
Methods: We use data from the Global Drug Survey 2020, a large online survey on drug use collected between November 2019 and February 2020. In all, 3364 respondents reported their self-treatment experiences with lysergic acid diethylamide (N = 1996) or psilocybin mushrooms (N = 1368). The primary outcome of interest was the 17-item self-treatment outcome scale, items reflecting aspects of well-being, psychiatric symptoms, social-emotional skills, and health behaviours.
Results: Positive changes were observed across all 17 outcome items, with the strongest benefits on items related to insight and mood. Negative effects were reported by 22.5% of respondents. High intensity of psychedelic experience, seeking advice before treatment, treating with psilocybin mushrooms and treating post-traumatic stress disorder were associated with higher scores on the self-treatment outcome scale after averaging values across all 17 items. Younger age, high intensity of experience and treating with LSD were associated with increased number of negative outcomes.
Conclusions: This study brings important insights into self-treatment practices with psychedelics in a large international sample. Outcomes were generally favourable, but negative effects appeared more frequent than in clinical settings. Our findings can help inform safe practices of psychedelic use in the community, and inspire clinical research. Future research can be improved with utilisation of prospective designs and additional predictive variables.