The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive function and quality of life. Components of the psilocybin experience will also be measured (persisting effects, quality of life, challenging experiences, etc). Investigators will assess feasibility and tolerability as rates of retention and challenging experiences, among other factors.
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Participant retention rate
Timeframe: Screening, Visit #1
Participant retention rate
Timeframe: Baseline Assessments, Visit #2
Participant retention rate
Timeframe: Preparatory Session #1, Visit #3 (on study day (-)14; 14 days prior to dosing)
Participant retention rate
Timeframe: Preparatory Session #2, Visit #4 (on study day (-) 7; 7 days prior to dosing)
Participant retention rate
Timeframe: Preparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
Participant retention rate
Timeframe: Day of drug administration, Visit #6 (on study day 0)
Participant retention rate
Timeframe: 1-Day post drug administration integration session, Visit #7
Participant retention rate
Timeframe: 7-Day post drug administration integration session, Visit #8
Participant retention rate
Timeframe: 30-days post drug administration follow-up (Follow-up #1), Visit #9
Participant retention rate
Timeframe: 60-days post drug administration follow-up (Follow-up #2), Visit #10
Participant retention rate
Timeframe: 120-days post drug administration follow-up (Follow-up #3), Visit #11 (Final visit)
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: Screening, Visit #1
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: Day of drug administration, Visit #6 (on study day 0)
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: 120 days post drug administration (Follow up #3), Visit #11(final visit)
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: Screening, Visit #1
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: 30 day post drug administration (Follow up #1), Visit #9
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: 60 day post drug administration (Follow up #2), visit #10
Preliminary efficacy of psilocybin on methamphetamine abstinence
Timeframe: 120 days post drug administration (Follow up #3), visit #11
Mystical experiences associated with psilocybin administration
Timeframe: Day of drug administration, Visit #6 (on study day 0)
Challenging experiences associated with psilocybin administration
Timeframe: Day of drug administration, Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Timeframe: Baseline - Visit #2
Physiological responses to psilocybin administration
Timeframe: Preparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
Physiological responses to psilocybin administration
Timeframe: Day of drug administration(hourly) - Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Timeframe: Post-session monitoring day of drug administration - Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Timeframe: Baseline - Visit #2
Physiological responses to psilocybin administration
Timeframe: Preparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
Physiological responses to psilocybin administration
Timeframe: Day of drug administration(hourly) - Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Timeframe: Post-session monitoring day of drug administration - Visit #6 (on study day 0)