Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial

This double-blind, placebo-controlled study (n=29) for those suffering from anxiety and depression, related to cancer, improved significantly (60-80% of participants) after a single dose of psilocybin (21mg/70kg) in combination with psychotherapy.

Abstract of Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer

Background: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression.

Methods: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks.

Results: Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month followup, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60–80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression.

Conclusions: In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress.”

Authors: Stephen Ross, Anthony Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara Malone, Barry Cohen, Sarah E. Mennenga, Alexander Belser, Krystallia Kalliontzi, James Babb, Zhe Su, Patricia Corby & Brian L. Schmidt

Notes on Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer

This study is followed up by a Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer (Agin-Liebis et al., 2020).

And by a qualitative analysis of Patient Experiences of Psilocybin-Assisted Psychotherapy: An Interpretative Phenomenological Analysis (Belser et al., 2017). And continued themes after the experience were also analysed (from the same dataset) by Swift and colleagues (2017). And another qualitative analysis of four patients by Malone and colleagues (2018).

The effects on suicidal ideation (SI) in this study group were done by Ross and colleagues (2021).

The article was published in the same edition of the Journal of Psychopharmacology as Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial (Griffiths & Johnson, 2016).

This study is included in a meta-analysis by Goldberg et al. (2020) – the effect of psilocybin on anxiety and depression, and another meta-analysis by Vargas et al. (2020) – the effect of psilocybin on anxiety and depression at end-of-life. And it was included in the meta-analytical review by Galvão-Coelho and colleagues (2021) that found psychedelics to improve mood (for those with mood disorders) both in the short and long term (up to 60 days).

“Enduring clinically significant anxiety and/or depressive symptoms are common in patients with cancer, present in 30–40% of patients in hospital settings.”

Single moderate-dose psilocybin, in conjunction with psychotherapy, produced rapid, robust, and sustained clinical benefits in terms of reduction of anxiety and depression in patients with life-threatening cancer. This pharmacological finding is novel in psychiatry in terms of a single dose of a medication leading to immediate anti-depressant and anxiolytic effects with enduring (e.g. weeks to months) clinical benefits. Even though it is not possible to attribute causality of the experimental drug (in terms of sustained clinical benefit) after the crossover, the post-crossover data analyses of the two dosing sequences suggest that the clinical benefits, in terms of reduction of cancer-related anxiety and depression, of single-dose psilocybin (in conjunction with psychotherapy) may be sustained for longer than 7 weeks postdosing, and that they may endure for as long as 8 months post psilocybin dosing.”

As the follow-up (Agin-Liebes et al., 2020) shows, this is a promising avenue for helping people with cancer-related psychological distress.

Since the early 1990s, approximately 2000 doses of psilocybin (ranging from low to high doses) have been safely administered to humans in the United States and Europe, in carefully controlled scientific settings, with no reports of any medical or psychiatric serious [adverse effects], including no reported cases of prolonged psychosis or HPPD. This finding is consistent with a US population (2001–2004 data from the National Survey on Drug Use and Health) based study that found no associations between lifetime use of any of the serotoninergic psychedelics (including psilocybin) and increased rates of mental illness.”

Summary of Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer

Patients with cancer who experience anxiety and/or depressive symptoms have worse outcomes, including medication non-adherence, increased healthcare utilization, adverse medical outcomes, decreased quality of life, and decreased survival rates.

Although pharmacotherapeutic and psychosocial interventions commonly treat anxiety and depression in cancer patients, their efficacy is mixed and limited.

In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression received treatment with single-dose psilocybin or niacin, both in conjunction with psychotherapy.

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Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial

https://doi.org/10.1177%2F0269881116675512

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Cite this paper (APA)

Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T., Cohen, B., ... & Schmidt, B. L. (2016). Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Journal of Psychopharmacology30(12), 1165-1180.

Study details

Compounds studied
Psilocybin

Topics studied
Palliative Care Anxiety Depression

Study characteristics
Original Placebo-Controlled Active Placebo Double-Blind

Participants
29 Humans

Authors

Authors associated with this publication with profiles on Blossom

Jeffrey Guss
Jeffrey Guss is a psychiatrist, psychoanalyst, and researcher with a specialization in the treatment of substance use disorders. He is a clinical assistant professor of psychiatry at the NYU School of Medicine.

Alexander Belser
Alexander Belser is a psychologist and psychedelic researcher at Yale University and New York University.

Institutes

Institutes associated with this publication

NYU Langone Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

Compound Details

The psychedelics given at which dose and how many times

Psilocybin 21 mg | 1x

Linked Research Papers

Notable research papers that build on or are influenced by this paper

Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial
This study (n=51) investigated the effects of a high dose of psilocybin (22 or 30mg/70kg) on depression and anxiety in patients with life-threatening cancer. It found significant improvements in clinician- and self-administered measures of depression and anxiety, even without psychotherapy (as many other studies provide). 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.

Patient Experiences of Psilocybin-Assisted Psychotherapy: An Interpretative Phenomenological Analysis
This qualitative analysis of experiences may help form new hypotheses on why a psychedelic experience works. Found is that participants experienced strong emotions, partly conveyed by music.

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer
This is a follow-up study (n=16) at an average of 3.8 years after a single dose of psilocybin, combined with psychotherapy, for patients suffering from cancer-related existential distress. Approximately 60-80% of participants experienced reduced anxiety or depressive symptoms. This adds to the body of research that indicates that the positive of a guided psychedelic experience can be long-lasting.

Individual Experiences in Four Cancer Patients Following Psilocybin-Assisted Psychotherapy
This case study describes patients (n=4) from a randomized, double-blind, placebo-controlled trial investigating single-dose psilocybin (21mg/70kg) psychotherapy to treat cancer-related anxiety and depression. These four participants’ personal narratives extended beyond the cancer diagnosis itself, frequently revolving around themes of self-compassion and love, acceptance of death, and memories of past trauma.

Cancer at the dinner table: experiences of psilocybin-assisted psychotherapy for the treatment of cancer-related distress
This interview study (n=13) analyzed the phenomenological themes associated with psilocybin therapy for anxiety and depression associated with cancer. Participants reported a felt reconnection to life, reconciliation with death, and other powerful subjective effects.

Linked Clinical Trial

Psilocybin Cancer Anxiety Study
The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness.

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