Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer
This is the first (modern) double-blind placebo-controlled study (n=12) of psilocybin (14mg/70kg) for the treatment of (end-of-life) anxiety (and depression) related to cancer. Treatment led to a significant reduction in anxiety symptoms up to three months after treatment and improvements in depressive symptoms reached significance after six months.
Authors
- Charles Grob
- Adam Halberstadt
- Alicia Danforth
Published
Abstract
Context
Researchers conducted extensive investigations of hallucinogens in the 1950s and 1960s. By the early 1970s, however, political and cultural pressures forced the cessation of all projects. This investigation reexamines a potentially promising clinical application of hallucinogens in the treatment of anxiety reactive to advanced-stage cancer.
Objective
To explore the safety and efficacy of psilocybin in patients with advanced-stage cancer and reactive anxiety.
Design
A double-blind, placebo-controlled study of patients with advanced-stage cancer and anxiety, with subjects acting as their own control, using a moderate dose (0.2 mg/kg) of psilocybin.
Setting
A clinical research unit within a large public sector academic medical center.
Participants
Twelve adults with advanced-stage cancer and anxiety.Main outcome measures: In addition to monitoring safety and subjective experience before and during experimental treatment sessions, follow-up data including results from the Beck Depression Inventory, Profile of Mood States, and State-Trait Anxiety Inventory were collected unblinded for 6 months after treatment.
Results
Safe physiological and psychological responses were documented during treatment sessions. There were no clinically significant adverse events with psilocybin. The State-Trait Anxiety Inventory trait anxiety subscale demonstrated a significant reduction in anxiety at 1 and 3 months after treatment. The Beck Depression Inventory revealed an improvement of mood that reached significance at 6 months; the Profile of Mood States identified mood improvement after treatment with psilocybin that approached but did not reach significance.
Conclusions
This study established the feasibility and safety of administering moderate doses of psilocybin to patients with advanced-stage cancer and anxiety. Some of the data revealed a positive trend toward improved mood and anxiety. These results support the need for more research in this long-neglected field.
Research Summary of 'Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer'
βBlossom's Take
Introduction
Interest in addressing the psychological, spiritual and existential distress experienced by patients with advanced-stage cancer has re-emerged after a long hiatus in clinical research. Earlier trials from the 1950s to early 1970s reported that hallucinogens could produce psychospiritual experiences associated with sustained improvements in mood and reduced anxiety in terminally ill patients, but research largely ceased for political and cultural reasons. Psilocybin, a naturally occurring psychedelic metabolised to psilocin and acting as an agonist at serotonin 5-HT1A/2A/2C receptors (with 5-HT2A activation linked to hallucinogenic effects), has been re-examined because recent studies in healthy volunteers and in selected clinical populations suggest it can safely induce profound subjective experiences and, in some settings, durable improvements in well‑being. Grob and colleagues conducted the present investigation to explore the safety and preliminary efficacy of a moderate dose of psilocybin for anxiety reactive to advanced-stage cancer. The study aimed to assess physiological safety during sessions, acute subjective effects, and changes in mood and anxiety over a 6-month follow-up period using within-subject, double-blind, placebo-controlled methods in a small clinical sample. By reviving a controlled approach to this question, the study sought to establish feasibility and to inform the design of future trials.
Methods
This was a within-subject, double-blind, placebo-controlled pilot study in which each participant received two experimental sessions several weeks apart: one with psilocybin (0.2 mg/kg, oral) and one with active placebo (niacin 250 mg). Twelve adults with advanced-stage cancer and a DSM‑IV diagnosis of an anxiety-related disorder (acute stress disorder, generalized anxiety disorder, anxiety disorder due to cancer, or adjustment disorder with anxiety) were enrolled. Recruitment used internet postings, flyers, presentations, clinician referrals and patient-support contacts; medical and psychiatric screening included brain MRI and communication with treating oncologists. Eleven participants were women; ages ranged from 36 to 58. Primary cancers included breast, colon, ovarian, peritoneal, salivary gland and multiple myeloma; duration of illness ranged from 2 months to 18 years. Eight subjects completed the 6‑month follow-up, 11 completed at least 4 months, and all 12 completed at least 3 months. Two subjects died during follow-up and two became too ill to continue; by 2010 ten of the twelve had died. Key exclusion criteria were central nervous system involvement of cancer, severe cardiovascular disease, untreated hypertension, abnormal hepatic or renal function, diabetes, lifetime psychotic or bipolar disorders, recent (within 1 year before cancer onset) anxiety or affective disorders, and certain medication contraindications (active chemotherapy, antiseizure drugs, insulin/oral hypoglycaemics, and psychotropic drugs within the prior 2 weeks). Subjects were asked to avoid most medications on the day of and the day after sessions, with defined exceptions for pain medications. Four participants had no prior hallucinogen experience; the remainder had varying historic exposure. Preparatory meetings with study staff established rapport and clarified session structure and intentions. Sessions occurred in a hospital clinical research unit in a comfortable room; participants were admitted the day before, wore eye shades and listened to preselected music during the acute session, and were monitored for 6 hours with hourly check-ins including heart rate and blood pressure measurements. Holter cardiac monitoring covered 24 hours starting at admission. Self-report instruments were administered at prespecified times: Beck Depression Inventory (BDI), Profile of Mood States (POMS) and State-Trait Anxiety Inventory (STAI) before sessions and at repeated follow-ups; the 5-Dimension Altered States of Consciousness profile (5D-ASC) and Brief Psychiatric Rating Scale (BPRS) were given at session end. Monthly telephone contact and scheduled follow-up assessments continued for 6 months after the second session. Statistical analyses used two-way analysis of variance (ANOVA) with drug as a within-subject factor and day or time as a repeated measure for BDI, POMS and STAI; 1-way ANOVA was used for 5D-ASC and BPRS comparisons. When two-way ANOVA indicated significant main effects or interactions, post hoc one-way ANOVAs or paired tests were performed for individual time points. Paired t tests compared follow-up scores with baseline. The report defines significance thresholds for each set of comparisons (typically α=.05, with a stricter threshold where multiple comparisons of cardiovascular measures were made). ANOVA is a method to test for differences between group means while accounting for repeated measures and interactions.
Results
Safety and cardiovascular monitoring indicated only modest physiological effects of psilocybin at the chosen dose. Heart rate and blood pressure rose modestly after psilocybin compared with niacin, with mean (SEM) peak systolic blood pressure during psilocybin sessions of 138.9 (6.4) mm Hg versus 117.0 (4.3) mm Hg during niacin sessions, and mean (SEM) peak diastolic blood pressure of 75.9 (3.4) mm Hg versus 69.6 (2.7) mm Hg. Holter monitoring showed no sustained tachyarrhythmias or heart block and was comparable between psilocybin and placebo sessions. There were no clinically significant adverse psychological events reported; participants tolerated sessions well and investigators observed no instances of severe acute anxiety or prolonged adverse reactions. Acute subjective effects measured by the 5D-ASC showed marked differences between psilocybin and placebo. Psilocybin produced large effects on the oceanic boundlessness dimension (F1,11=33.12, P<.001) and visionary restructuralization (F1,11=18.95, P=.001), with smaller but statistically significant effects on anxious ego dissolution (F1,11=4.91, P=.049) and auditory alterations (F1,11=5.93, P=.03). Item clusters that increased significantly with psilocybin included positive derealization, positive depersonalization, altered sense of time, positive mood, manialike experiences, elementary hallucinations, visual pseudohallucinations, synesthesia, changed meaning of percepts, facilitated recollection and imagination. Subscales showing no appreciable differences included anxious derealization, thought disorder, delusion and fears of loss of control. Mood and anxiety measures yielded mixed but some promising signals. For the BDI there was an interaction of drug and day that approached but did not reach conventional significance (F1,11=3.75, P=.08). Mean BDI scores trended downward after psilocybin from 16.1 (3.6) one day before treatment to 10.0 (2.7) two weeks after; BDI scores fell by almost 30% from the first session to 1 month after the second session (t11=-2.17, P=.05) and this improvement was sustained and statistically significant at the 6-month follow-up (t7=2.71, P=.03). The POMS showed a trend toward reduced adverse mood following psilocybin (drug×time interaction F3,33=2.71, P=.06). Notably, mean POMS scores were elevated one day before psilocybin treatment (F1,11=7.48, P=.02) relative to placebo sessions, a difference that disappeared by 6 hours post‑administration; POMS scores were reduced after psilocybin in 11 of 12 subjects, but overall POMS values were not changed across the full 6‑month follow-up compared with baseline. Anxiety outcomes differed by STAI subscale. State anxiety showed no significant changes from baseline to 2 weeks, though a non-significant reduction at 6 hours after psilocybin was observed. In contrast, STAI trait anxiety demonstrated a sustained decrease across the 6‑month follow-up, reaching significance at 1 month (t11=4.36, P=.001) and at 3 months (t10=2.55, P=.03) after the second treatment session. The BPRS recorded at session end revealed no appreciable differences between psilocybin and placebo. Pain and somatic symptom effects were not robustly altered by the moderate psilocybin dose. Some participants reported lessened pain in the two weeks after sessions while others did not, and no consistent difference between psilocybin and placebo was evident in the data presented.
Discussion
Grob and colleagues framed the study primarily as establishing feasibility and safety for administering a moderate psilocybin dose to patients with advanced-stage cancer and reactive anxiety. The selected 0.2 mg/kg dose reflected regulatory and institutional discussions; it was intended to balance the potential for an altered state of consciousness with minimised risk. Physiological data supported safety at this dose: only mild sympathomimetic effects were observed and continuous cardiac monitoring did not reveal increased arrhythmias relative to niacin placebo. Psychological safety was also supported, with no reports of severe anxiety or so‑called "bad trips" and only modest effects on measures of anxious ego dissolution. The investigators interpreted the subjective and longer‑term psychological data as suggestive but preliminary. Acute psilocybin sessions produced clear phenomenological effects (oceanic boundlessness, visionary phenomena) and many participants reported meaningful insights about life, relationships and mortality during sessions and in monthly follow-up discussions; however, the frequency of these qualitative reports was not quantified. Quantitative measures showed a sustained reduction in STAI trait anxiety with significance at 1 and 3 months, and BDI scores demonstrated a significant improvement by 6 months. POMS results suggested mood improvement in most participants but did not reach robust statistical significance over the follow-up period. The absence of consistent pain reduction contrasted with some earlier reports and may reflect the lower dose used here. Several limitations were acknowledged. The small sample size and heterogeneity of the cohort constrain generalisability and statistical power. Although the within-subject, double-blind design was intended to be rigorous, unblinding was common because the active drug's effects were generally apparent to participants and staff; many participants perceived placebo sessions as less valuable. Variability in post‑session contact and support (beyond a minimum monthly hour) may have influenced outcomes, and the ethical choice to allow all participants to receive the experimental medicine removed the option of an independent control group receiving only placebo or standard pharmacotherapy. The moderate dose may have limited the intensity of psychospiritual experiences and thus therapeutic effects compared with historical higher-dose protocols. Despite these constraints, the investigators concluded that carefully controlled administration of psilocybin in this population appears feasible and reasonably safe, and that the observed reductions in trait anxiety and trends toward improved mood warrant further research. They recommended future studies with larger samples, consideration of higher doses or repeated dosing, improved blinding strategies or independent control groups, and standardised post-session support to better assess efficacy and mechanisms while maintaining stringent safety protocols.
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METHODS
Twelve subjects with advanced-stage cancer and a DSM-IVdiagnosis of acute stress disorder, generalized anxiety disorder, anxiety disorder due to cancer, or adjustment disorder with anxiety were recruited into a within-subject, double-blind, placebocontrolled study to examine the safety and efficacy of psilocybin in the treatment of psychological distress associated with the existential crisis of terminal disease. Participants were recruited through Internet postings, flyer distribution, presentations at local hospitals and wellness centers, oncologist referrals, and study registration on clinicaltrials.gov and by contacting local patient support agencies and health care providers. Medical and psychiatric screening including brain magnetic resonance imaging, communication with treating oncologists, formal psychiatric diagnostic interviews, and informed consent were required for enrollment into the study. Subjects were not paid for their participation. The institutional review board of the Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, California, approved the protocol and monitored the study. Of the 12 subjects, 11 were women. Subjects' ages ranged from 36 to 58 years. Primary cancers included breast cancer in 4 subjects, colon cancer in 3, ovarian cancer in 2, peritoneal cancer in 1, salivary gland cancer in 1, and multiple myeloma in 1. All subjects were in advanced stages of their illness. The duration of their primary cancers ranged from 2 months to 18 years. Eight subjects completed the 6-month follow-up assessment, 11 completed at least the first 4 months of assessment, and all 12 completed at least the first 3 months of follow-up. Two subjects died of their cancer during the follow-up period, and 2 others became too ill to continue participating. The study was conducted from June 2004 to May 2008. By the time of submission of this report in 2010, 10 of the 12 subjects had died. Exclusion criteria included central nervous system involvement of the cancer, severe cardiovascular illness, untreated hypertension, abnormal hepatic or renal function, diabetes, lifetime history of schizophrenia, bipolar disease, other psychotic illness, and anxiety or affective disorders within 1 year prior to the onset of cancer. Medication contraindications included active cancer chemotherapy, antiseizure medications, insulin and oral hypoglycemics, and psychotropic medications in the previous 2 weeks. Subjects also were asked to refrain from taking any medications the day of and the day after the experimental treatment sessions, except for prescription or over-thecounter nonnarcotic pain medications at any time and narcotic pain medications up to 8 hours before and 6 hours after administration of the experimental medicine. Four subjects had no prior hallucinogen experience. Of the remaining 8, 4 had hallucinogen experience more than 30 years ago. Two had their last experience more than 5 years ago, and the other 2 had taken a hallucinogen within the year prior to their participation in the study. Hallucinogens taken included LSD (7 subjects), hallucinogenic mushrooms (5 subjects), peyote (2 subjects), and ayahuasca (2 subjects). Subjects met with study staff to review the purpose and intention of participation in the study, the treatment goals, the structure of the experimental treatment sessions, and critical issues to be examined during the course of the treatments. Subjects were informed of the range of emotional reaction that might be experienced while under the influence of psilocybin, including challenging psychological issues that might arise, and were informed that the purpose of the investigation was to determine whether psilocybin could ameliorate the anxiety associated with their advanced-stage cancer. Additional goals of these meetings included establishing a comfortable level of rapport and trust between the patient and research personnel, reviewing significant life issues in the patient's history, and the nature and status of present relationships and concerns. All experimental sessions took place in a hospital clinical research unit in a room decorated with fabric wall hangings and fresh flowers to provide a pleasing and comfortable environment. Subjects were admitted on the afternoon of the day prior to treatment. A Holter cardiac monitor was attached for 24 hours beginning at admission. Following medical and nursing evaluations, the treatment team met with the subject to review the procedure for the treatment session (described later), confirm the subject's personal intentions, and answer any additional questions. Subjects spent the night in the room on the research unit and were provided dinner and a light breakfast before 06:30 hours. On the morning of treatment, the therapeutic team met with the subject to administer presession instruments, attend to patient comfort, and review treatment procedures for the session one final time. Each subject acted as his or her own control and was provided 2 experimental treatment sessions spaced several weeks apart. They were informed that they would receive active psilocybin (0.2 mg/kg) on one occasion and the placebo, niacin (250 mg), on the other occasion. Psilocybin and placebo were administered in clear 00 capsules with corn starch and swallowed with 100 mL of water. A niacin placebo was chosen because it often induces a mild physiological reaction (eg, flush-ing) without altering the psychological state. The order in which subjects received the 2 different treatments was randomized and known only by the research pharmacist. Treatment team personnel remained at the bedside with the subject for the entire 6-hour session. Psilocybin or placebo was administered at 10:00 hours. The subject was encouraged to lie in bed wearing eye shades during the first few hours as well as to put on headphones to listen to preselected music. Subjects were allowed to remain undisturbed until each hour point, when treatment staff checked to inquire how they were doing. Contact was generally brief; subjects had been advised that there would be ample opportunity after the session and in subsequent days, weeks, and months to discuss the content of the experience. During hourly check-ins, heart rate (HR) and blood pressure (BP) measurements also were taken. Noncaffeinated clear liquids or juices were permitted. At the conclusion of the 6-hour session, subjects discussed the subjective aesthetic, cognitive, affective, and psychospiritual experiences they had during the session and completed rating instruments. Various self-report inventories and questionnaires were administered from 2 weeks prior to the first treatment session to up to 6 months after the second. Treatment team personnel maintained contact with subjects for the entire 6-month follow-up period, including regularly scheduled monthly telephone calls to update data on adverse events, concomitant medications, and evolving medical and psychological status.
RESULTS
Raw BDI, POMS, and STAI data were analyzed using 2-way analysis of variance (ANOVA) with drug as the withinsubject factor and day as a repeated measure. When the 2-way ANOVA detected significant main effects of drug or interactions between day and drug, post hoc pairwise comparisons were performed by 1-way ANOVA for each day. The 5D-ASC data were analyzed using 1-way ANOVA with drug as a within-subject factor. Item clusters comprising the oceanic boundlessness, anxious ego dissolution, and visionary restructuralization dimensions also were analyzed using 1-way ANOVA.The Brief Psychiatric Rating Scale data were analyzed using 1-way ANOVA with drug as a withinsubject factor. The HR and BP data were analyzed using 2-way ANOVA with drug as a within-subject factor and time as a repeated measure. When the 2-way ANOVA detected significant main effects of drug or interactions between time and drug, pairwise post hoc comparisons were performed by 1-way ANOVA at each time. For the measures listed earlier, significance was demonstrated by surpassing an ␣ level of .05. Paired t tests were used to assess whether niacin placebo and psilocybin produced effects on HR and BP compared with the predrug time, and significance was demonstrated for these multiple comparisons by surpassing an ␣ level of .025. For the BDI, POMS, and STAI, data from each of the 6 follow-up times were compared with the baseline value obtained on the day before the first treatment session, using t tests. For the follow-up data, significance was demonstrated by surpassing an ␣ level of .05.
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Study Details
- Study Typeindividual
- Populationhumans
- Characteristicsplacebo controlleddouble blindrandomizedparallel groupfollow up
- Journal
- Compound
- Topics
- Authors
- APA Citation
References (8)
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