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1.
Hastings Cent Rep ; 54(4): 32-46, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39116148

RESUMO

Well-trained, competent therapists are crucial for safe and effective psychedelic-assisted therapy (PAT). The question whether PAT training programs should require aspiring therapists to undergo their own PAT-commonly referred to as "experiential training"-has received much attention within the field. In this article, we analyze the potential benefits of experiential training in PAT by applying the framework developed by Rolf Sandell et al. concerning the functions of any training therapy (the therapeutic, modeling, empathic, persuasive, and theoretical functions). We then explore six key domains in which risks could arise through mandatory experiential training: physical and psychological risks; negative impact on therapeutic skill; justice, equity, diversity, and inclusion; dual relationships; privacy and confidentiality; and undue pressure. Ultimately, we argue that experiential training in PAT should not be mandatory. Because many PAT training programs already incorporate experiential training methods, our exploration of potential harms and benefits may be used to generate comprehensive risk-mitigation strategies.


Assuntos
Alucinógenos , Humanos , Alucinógenos/administração & dosagem , Medição de Risco , Psicoterapia , Confidencialidade , Competência Clínica
2.
Focus (Am Psychiatr Publ) ; 21(3): 315-328, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37404971

RESUMO

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. Appeared originally in Nat Med 2021; 27:1025-1033.

4.
Nat Med ; 27(6): 1025-1033, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33972795

RESUMO

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was -24.4 (s.d. 11.6) in the MDMA group and -13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , N-Metil-3,4-Metilenodioxianfetamina/administração & dosagem , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Adulto , Terapia Combinada , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , N-Metil-3,4-Metilenodioxianfetamina/efeitos adversos , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/patologia , Resultado do Tratamento
5.
J Psychopharmacol ; 34(6): 612-622, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32108529

RESUMO

RATIONALE: Microdosing psychedelics - the practice of consuming small, sub-hallucinogenic doses of substances such as LSD or psilocybin - is gaining attention in popular media but remains poorly characterized. Contemporary studies of psychedelic microdosing have yet to report the basic psychiatric descriptors of psychedelic microdosers. OBJECTIVES: To examine the practices and demographics of a population of psychedelic microdosers - including their psychiatric diagnoses, prescription medications, and recreational substance use patterns - to develop a foundation on which to conduct future clinical research. METHODS: Participants (n = 909; Mage = 26.9, SD = 8.6; male = 83.2%; White/European = 79.1%) recruited primarily from the online forum Reddit completed an anonymous online survey. Respondents who reported using LSD, psilocybin, or both for microdosing were grouped and compared with non-microdosing respondents using exploratory odds ratio testing on demographic variables, rates of psychiatric diagnoses, and past-year recreational substance use. RESULTS: Of microdosers, most reported using LSD (59.3%; Mdose = 13 mcg, or 11.3% of one tab) or psilocybin (25.9%; Mdose = 0.3 g of dried psilocybin mushrooms) on a one-day-on, two-days-off schedule. Compared with non-microdosers, microdosers were significantly less likely to report a history of substance use disorders (SUDs; OR = 0.17 (95% CI: 0.05-0.56)) or anxiety disorders (OR = 0.61 (95% CI: 0.41-0.91)). Microdosers were also more likely to report recent recreational substance use compared with non-microdosers (OR = 5.2 (95% CI: 2.7-10.8)). CONCLUSIONS: Well-designed randomized controlled trials are needed to evaluate the safety and tolerability of this practice in clinical populations and to test claims about potential benefits.


Assuntos
Alucinógenos/administração & dosagem , Dietilamida do Ácido Lisérgico/administração & dosagem , Psilocibina/administração & dosagem , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adolescente , Adulto , Estudos Transversais , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Transtornos Mentais/epidemiologia , Inquéritos e Questionários , Adulto Jovem
6.
Harm Reduct J ; 16(1): 43, 2019 07 10.
Artigo em Inglês | MEDLINE | ID: mdl-31288862

RESUMO

BACKGROUND: Microdosing psychedelics is the practice of consuming very low, sub-hallucinogenic doses of a psychedelic substance, such as lysergic acid diethylamide (LSD) or psilocybin-containing mushrooms. According to media reports, microdosing has grown in popularity, yet the scientific literature contains minimal research on this practice. There has been limited reporting on adverse events associated with microdosing, and the experiences of microdosers in community samples have not been categorized. METHODS: In the present study, we develop a codebook of microdosing benefits and challenges (MDBC) based on the qualitative reports of a real-world sample of 278 microdosers. RESULTS: We describe novel findings, both in terms of beneficial outcomes, such as improved mood (26.6%) and focus (14.8%), and in terms of challenging outcomes, such as physiological discomfort (18.0%) and increased anxiety (6.7%). We also show parallels between benefits and drawbacks and discuss the implications of these results. We probe for substance-dependent differences, finding that psilocybin-only users report the benefits of microdosing were more important than other users report. CONCLUSIONS: These mixed-methods results help summarize and frame the experiences reported by an active microdosing community as high-potential avenues for future scientific research. The MDBC taxonomy reported here informs future research, leveraging participant reports to distil the highest-potential intervention targets so research funding can be efficiently allocated. Microdosing research complements the full-dose literature as clinical treatments are developed and neuropharmacological mechanisms are sought. This framework aims to inform researchers and clinicians as experimental microdosing research begins in earnest in the years to come.


Assuntos
Ensaios Clínicos Fase I como Assunto , Alucinógenos/administração & dosagem , Adolescente , Adulto , Afeto/efeitos dos fármacos , Ansiedade/induzido quimicamente , Nível de Alerta/efeitos dos fármacos , Atenção/efeitos dos fármacos , Estudos Transversais , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Teoria Fundamentada , Fidelidade a Diretrizes , Alucinógenos/efeitos adversos , Humanos , Dietilamida do Ácido Lisérgico/administração & dosagem , Dietilamida do Ácido Lisérgico/efeitos adversos , Masculino , Pessoa de Meia-Idade , Psilocibina/administração & dosagem , Psilocibina/efeitos adversos , Estudos Retrospectivos , Medição de Risco
7.
Psychopharmacology (Berl) ; 236(2): 731-740, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30604183

RESUMO

RATIONALE: Microdosing psychedelics-the regular consumption of small amounts of psychedelic substances such as LSD or psilocybin-is a growing trend in popular culture. Recent studies on full-dose psychedelic psychotherapy reveal promising benefits for mental well-being, especially for depression and end-of-life anxiety. While full-dose therapies include perception-distorting properties, microdosing mayprovide complementary clinical benefits using lower-risk, non-hallucinogenic doses. OBJECTIVES: This pre-registered study aimed to investigate whether microdosing psychedelics is related to differences in personality, mental health, and creativity. METHODS: In this observational study, respondents recruited from online forums self-reported their microdosing behaviors and completed questionnaires concerning dysfunctional attitudes, wisdom, negative emotionality, open-mindedness, and mood. Respondents also performed the Unusual Uses Task to assess their creativity. RESULTS: Current and former microdosers scored lower on measures of dysfunctional attitudes (p < 0.001, r = - 0.92) and negative emotionality (p = 0.009, r = - 0.85) and higher on wisdom (p < 0.001, r = 0.88), openmindedness(p = 0.027, r = 0.67), and creativity (p < 0.001, r = 0.15) when compared to non-microdosing controls. CONCLUSIONS: These findings provide promising initial evidence that warrants controlled experimental research to directly test safety and clinical efficacy. As microdoses are easier to administer than full-doses, this new paradigm has the exciting potential to shape future psychedelic research.


Assuntos
Criatividade , Emoções/efeitos dos fármacos , Alucinógenos/administração & dosagem , Saúde Mental , Personalidade/efeitos dos fármacos , Adulto , Ansiedade/tratamento farmacológico , Ansiedade/psicologia , Depressão/tratamento farmacológico , Depressão/psicologia , Relação Dose-Resposta a Droga , Emoções/fisiologia , Feminino , Humanos , Dietilamida do Ácido Lisérgico/administração & dosagem , Masculino , Saúde Mental/tendências , Percepção/efeitos dos fármacos , Percepção/fisiologia , Personalidade/fisiologia , Psilocibina/administração & dosagem , Inquéritos e Questionários
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