Efficacy and safety of ayahuasca ritual use in the treatment of alcohol use disorder: an open randomized controlled study
Substance use disorder constitutes a public health issue whose treatment available is limited and effectiveness is relatively low. In Brazil, about 17% of the population meets the criteria for alcohol use disorder. Recent evidence indicates that psychedelics can be useful as therapeutic agents in the treatment of substance use disorders. Ayahuasca – a beverage prepared from the decoction of two psychoactive plants, Banisteriopsis caapi and Psychotria viridis, used in traditional Amazonian medicine – stands out in the international literature, presenting significant therapeutic effects and no serious adverse effects in preliminary studies. This study aims to mitigate gaps noted in previous studies on the effects of ayahuasca on parameters related to problematic drug use. The evaluation will be conducted through comparing two randomized: (a) participants who will receive standard treatment in an outpatient service (control group); and (b) participants who will attend five ayahuasca ritual sessions, in addition to the standard treatment. The sample (n = 60) will consist of individuals diagnosed with alcohol use disorder, male, aged between 21 and 65 years. The therapeutic efficacy will be assessed by means of inventories on the pattern of alcohol consumption, dependence severity and craving. Additional inventories will be used to assess factors associated with alcohol use disorder, related to psychiatric symptoms and quality of life. Safety will be assessed by the presence or absence of adverse reactions and through clinical and laboratory tests. Blood and saliva collections will be carried out to measure alkaloids of ayahuasca and neurotrophic biomarkers. The parameters will be evaluated simultaneously in each group, pre- and post-intervention and at follow-up assessments that will occur at three, six and twelve months after the intervention. The study will be conducted between 2016 and 2017. We believe that ICPR is an opportunity to discuss and possibly improve the study design and protocol.
Luís Fernando Tófoli graduated in Medicine at the University of São Paulo (1996), completed his medical residency in Psychiatry (2000) at the Institute of Psychiatry, University of São Paulo Medical School, and his Ph.D. in Medicine (Psychiatry) at the University of São Paulo (2004). He is currently a professor at the Department of Medical Psychology and Psychiatry of the Medical Science School at the State University of Campinas (UNICAMP) and member of three graduate programs: Medical Sciences/Mental Health and Internal Medicine/Health Professions Education at UNICAMP. He has experience in Mental Health and Psychiatry, acting on the following subjects: primary care mental health, mental health and drug policies, ayahuasca and medically unexplained symptoms (somatic distress). He coordinates the Laboratory of Interdisciplinary Studies on Psychoactive Drugs (LEIPSI) in Campinas, Brazil.