Mental and behavioural disorders due to use of tobacco: dependence syndrome Mental and behavioural disorders due to use of tobacco
Conditions
Interventions
This is an open-label, non-randomized, single-arm pilot clinical study without blinding investigating the use of Psilocybe cubensis to reduce tobacco consumption in smokers. A total of 15 participants
Sponsors
Universidade Federal de São Paulo
Centro de Estudos Paulista de Psiquiatria
Eligibility
Age
21 Years to 60 Years
Inclusion criteria
Inclusion criteria: Current diagnosis of Tobacco Use Disorder (APA, 2013); smokes at least 10 cigarettes a day; concerned about the smoking habit and seeking treatment; consents to participate in the research, by agreeing to and signing a Free and Informed Consent Form; agrees to abstain from alcohol or other psychotropic substances, with the exception of tobacco, 24 hours prior to the experimental drug administration sessions; available family members or friends who can pick up and accompany overnight after the experimental drug administration session.
Exclusion criteria
Exclusion criteria: Kidney, liver, heart, neurological or esophageal diseases; blood pressure exceeding 140 mm Hg systolic and 90 mm Hg diastolic; cancer as a result of tobacco consumption; psychiatric symptoms (acute psychosis, suicidal ideation, bipolar disorder or severe symptoms of depression or anxiety); personal history of a clinically significant suicide attempt; family history of schizophrenia, bipolar disorder or suicide; personal history of 10 or more occasions of psychedelic substance use, or some use in the past 30 days; diagnosis of Substance Use Disorder (except tobacco) in the last 48 months; active legal problems with potential result of incarceration; current use of selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase (MAOIs) inhibitors; current use of naltrexone, disulfiram, acamprosate, methylphenidate, bupropion, varenicline, baclofen; clinical indication for hospitalization; possibility of adverse emotional or behavioral reactions according to clinical assessment (i.e., evidence of personality disorders, severe current stressors, lack of significant social support); possibility of pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of treatment effectiveness for Tobacco Use Disorder is expected to be observed through measures of exhaled carbon monoxide (CO) and urinary cotinine, defined by levels below 6 ppm for CO and below 200 ng/mL for cotinine (Bramer and Kallungal, 2003; Javors et al., 2005; Middleton and Morice, 2000), collected at baseline, during sessions with Psilocybe cubensis and at weeks 1, 4, 5, 8, 12, and 24 following the first session with the experimental substance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evidence of reduction in tobacco consumption is expected to be observed through the Timeline Follow-Back (TLFB) method, based on the observed changes in patterns of use between baseline, day 1 and weeks 1, 4, 5, 8, 12, and 24 following the first experience with the experimental substance. No predefined threshold is established for this outcome, which will be descriptively analyzed.;Evidence of improvement in tobacco dependence, craving, and withdrawal is expected to be observed through the Fagerström Test for Nicotine Dependence (FTND), the Brief Questionnaire of Smoking Urges (QSU-Brief), the Smoking Abstinence Questionnaire (SAQ), and the Wisconsin Smoking Withdrawal Scale, administered at baseline, on day 1, and at weeks 1, 4, 5, 8, 12, and 24 following the first experience with the experimental substance. No predefined threshold is established for these outcomes, which will be analyzed descriptively.;Neurocognitive functions in participants throughout the treatment are expected to be assessed using the Psychology Experiment Building Language (PEBL), administered at baseline, on day 1, and at weeks 1, 4, 5, 8, 12, and 24 following the first experience with the experimental substance. No predefined threshold is established for this outcome, which will be analyzed descriptively.;Personality in participants throughout the treatment is expected to be assessed using the Big Five Inventory (BFI), administered at baseline, on day 1, and at weeks 1, 4, 5, 8, 12, and 24 following the first experience with the experimental substance. No predefined threshold is established for this outcome, which will be analyzed descriptively.;Quality of life in participants is expected to be assessed using the World Health Organization Quality of Life Instrument – Spirituality, Religiosity and Personal Beliefs Module (WHOQOL–SRPB), administered on the day following the two sessions with the experimental substance. No predefined threshold is established for this outcome, which will be ana | — |
Countries
BR
Contacts
Public ContactRenato Filev
Universidade Federal de São Paulo
Outcome results
None listed