IMPORTANCEAlthough classic psychedelic medications have shown promise in the treatment of alcohol use disorder (AUD), the efficacy of psilocybin remains unknown. OBJECTIVE To evaluate whether 2 administrations of high-dose psilocybin improve the percentage of heavy drinking days in patients with AUD undergoing psychotherapy relative to outcomes observed with active placebo medication and psychotherapy. DESIGN, SETTING, AND PARTICIPANTSIn this double-blind randomized clinical trial, participants were offered 12 weeks of manualized psychotherapy and were randomly assigned to receive psilocybin vs diphenhydramine during 2 day-long medication sessions at weeks 4 and 8. Outcomes were assessed over the 32-week double-blind period following the first dose of study medication. The study was conducted at 2 academic centers in the US. Participants were recruited from the community between March 12, 2014, and March 19, 2020. Adults aged 25 to 65 years with a DSM-IV diagnosis of alcohol dependence and at least 4 heavy drinking days during the 30 days prior to screening were included. Exclusion criteria included major psychiatric and drug use disorders, hallucinogen use, medical conditions that contraindicated the study medications, use of exclusionary medications, and current treatment for AUD.INTERVENTIONS Study medications were psilocybin, 25 mg/70 kg, vs diphenhydramine, 50 mg (first session), and psilocybin, 25-40 mg/70 kg, vs diphenhydramine, 50-100 mg (second session). Psychotherapy included motivational enhancement therapy and cognitive behavioral therapy. MAIN OUTCOMES AND MEASURESThe primary outcome was percentage of heavy drinking days, assessed using a timeline followback interview, contrasted between groups over the 32-week period following the first administration of study medication using multivariate repeated-measures analysis of variance.RESULTS A total of 95 participants (mean [SD] age, 46 [12] years; 42 [44.2%] female) were randomized (49 to psilocybin and 46 to diphenhydramine). One participant (1.1%) was American Indian/Alaska Native, 5 (5.3%) were Black, 16 (16.8%) were Hispanic, and 75 (78.9%) were non-Hispanic White. Of the 95 randomized participants, 93 received at least 1 dose of study medication and were included in the primary outcome analysis. Percentage of heavy drinking days during the 32-week double-blind period was 9.7% for the psilocybin group and 23.6% for the diphenhydramine group, a mean difference of 13.9%; (95% CI, 3.0-24.7; F 1,86 = 6.43; P = .01). Mean daily alcohol consumption (number of standard drinks per day) was also lower in the psilocybin group. There were no serious adverse events among participants who received psilocybin.CONCLUSIONS AND RELEVANCE Psilocybin administered in combination with psychotherapy produced robust decreases in percentage of heavy drinking days over and above those produced by active placebo and psychotherapy. These results provide support for further study of psilocybin-assisted treatment for AUD.
After a hiatus of some 40 years, clinical research has resumed on the use of classic hallucinogens to treat addiction. Following completion of a small open-label feasibility study, we are currently conducting a double-blind placebo-controlled clinical trial of psilocybin-assisted treatment of alcohol use disorder. Although treatment effects cannot be analyzed until the study is complete, descriptive case studies provide a useful window into the therapeutic process of psychedelic-assisted treatment of addiction. Here we describe treatment trajectories of three participants in the ongoing trial to illustrate the range of experiences and persisting effects of psilocybin treatment. Although it is difficult to generalize from a few cases, several qualitative conclusions can be drawn from the data presented here. Although participants often find it difficult to describe much of their psilocybin experience, pivotal moments tend to be individualized, extremely vivid, and memorable. Often, the qualitative content extends beyond the clinical problem that is being addressed. The participants discussed in this paper experienced acute and lasting alterations in their perceptions of self, in the quality of their baseline consciousness, and in their relationship with alcohol and drinking. In these cases, experiences of catharsis, forgiveness, self-compassion, and love were at least as salient as classic mystical content. Finally, feelings of increased “spaciousness” or mindfulness, and increased control over choices and behavior were reported following the drug administration sessions. Ultimately, psilocybin-assisted treatment appears to elicit experiences that are extremely variable, yet seem to meet the particular needs of the individual.
A growing body of evidence shows that existential and spiritual well-being in cancer patients is associated with better medical outcomes, improved quality of life, and serves as a buffer against depression, hopelessness, and desire for hastened death. Historical and recent research suggests a role for psilocybin-assisted psychotherapy in treating cancer-related anxiety and depression. A double-blind controlled trial was performed, where 29 patients with cancer-related anxiety and depression were randomly assigned to treatment with single-dose psilocybin (0.3 mg/kg) or niacin in conjunction with psychotherapy. Previously published results of this trial demonstrated that, in conjunction with psychotherapy, moderate-dose psilocybin produced rapid, robust, and enduring anxiolytic, and anti-depressant effects. Here, we illustrate unique clinical courses described by four participants using quantitative measures of acute and persisting effects of psilocybin, anxiety, depression, quality of life, and spiritual well-being, as well as qualitative interviews, written narratives, and clinician notes. Although the content of each psilocybin-assisted experience was unique to each participant, several thematic similarities and differences across the various sessions stood out. 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, though the specific details or narrative content differ substantially. The results presented here demonstrate the personalized nature of the subjective experiences elicited through treatment with psilocybin, particularly with respect to the spiritual and/or psychological needs of each patient.
Accurate recognition of gender in another individual is integral to successful human social interaction and to mate selection. When we encounter another person, we are effortlessly able to identify their gender, most often through the information conveyed by their facial features. Faces comprise the most abundantly encountered cue used to classify human gender. Considering the importance of facial information in gender perception, relatively little is known about the mechanisms involved in perceiving gender through human facial cues. We used an event-related fMRI repetition suppression paradigm to explore the neural circuitry underlying gender perception from facial information. Participants viewed brief consecutive images consisting of either gender-same face pairings (two male faces or two female faces) or images of gender-different face pairings (a male face preceded or followed by a female face), while attending to facial attractiveness in both conditions. Using a region-of-interest approach, we found repetition suppression on gender-same trials within the left ventral temporal fusiform gyrus and in the right collateral sulcus. Whole-brain voxel-wise analyses revealed selectivity for face gender again in the right collateral sulcus, in addition to the left cuneus and the right lateral occipital gyrus. Our results indicate that in addition to the face-selective FFA, cortical areas that are not traditionally considered to be "face-selective" are involved in the perception of gender-based facial cues.
Psychedelic substances have been central to religious and shamanic healing practices of various cultures for generations. More recently, in western medicine, psychedelic substances have demonstrated promise in the treatment of various mental health indications. A growing evidence base supports not only the therapeutic potential of psychedelic-assisted psychotherapy, but also the importance of integrating spiritual aspects of psychedelic experiences into the traditional therapeutic process. Psilocybin, a classic psychedelic, is a serotonergic hallucinogen that can elicit profound spiritual experiences even in the research setting. Our group is currently conducting a randomized controlled trial exploring the therapeutic potential of psilocybin-assisted psychotherapy for alcohol dependence. Over the course of the trial, many individuals have reported experiences that take a variety of forms, including spiritual insights, beatific visions, and communion with the Divine. Here we present three case studies of experiences involving communion with a deceased loved one, with a holy figure, and with the Divine from our clinical trial. These cases have been selected to illustrate the diverse nature of the spiritual experiences observed in this clinical trial, and to also explore elements of spiritual care that may be supportive in the psychotherapeutic process during and after the medication experiences. Should psychedelic medicine continue to show treatment promise in clinical trial stages, there is a strong possibility that these medicines will become an integral part of psychotherapy, which will require integration of direct spiritual experiences and spiritual care into the healing process.
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