An Early Phase 1 interventional study of Psilocybin 25 mg in Methamphetamine Use Disorder, sponsored by Kevin Murnane. Recruiting at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by Kevin Murnane · Early Phase 1, Interventional, and Treatment
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.
This is an open-label pilot study evaluating the feasibility and tolerability of a single 25 mg psilocybin dose in promoting abstinence from methamphetamine. Participants will attend 10 to 12 study visits over a period of up to six months.
Participants will be recruited from a population receiving treatment for methamphetamine dependence at a local residential treatment facility. Recruitment will involve informative presentations to current clients and counselor-facilitated referrals based on provided inclusion criteria. Prescreening will utilize information collected by the treatment center during the client's admission process.
Individuals who meet prescreening criteria will be invited to an in-person screening visit, conducted after obtaining informed consent. The screening visit will include a clinical review, a detailed psychiatric interview, self-report questionnaires, a comprehensive medical history, and safety laboratory testing, including blood draws.
Once eligibility is confirmed, participants will proceed with study enrollment and complete baseline assessments, which will measure substance use, quality of life, and executive function. Three preparatory sessions will follow over a two-week period to establish trust and rapport between participants and session monitors, educate participants on the study protocol, and prepare them for the psilocybin session. Two preparatory sessions may be conducted via telehealth to enhance feasibility, while the third will be conducted in person with both the primary and secondary monitors present. A medical examination will be performed within the week preceding psilocybin administration.
Within a week of the third preparatory session, participants will attend a psilocybin administration session. Participants will arrive at the study location by 9:30 AM and undergo safety screenings, including breathalyzer testing, before psilocybin administration at approximately 10:00 AM. Participants will have been instructed to consume a low-fat breakfast prior to arrival. During the session, cardiovascular measures (e.g., heart rate, blood pressure) will be monitored upon arrival, hourly throughout the session, and as clinically indicated.
The psilocybin session, lasting approximately 6-8 hours, will be monitored by both the primary and secondary session monitors, ensuring that at least one individual is present with the participant at all times. At the conclusion of the session, participants will complete questionnaires assessing their subjective experiences. Participants will then be released into the care of treatment center staff, who will provide emotional support. Participants will also receive contact information for the primary monitor to access support if needed.
Post-session integration will include two telehealth sessions: the first within one day of the psilocybin session and the second approximately 7 days later (±3 days). These sessions will provide opportunities to discuss insights or challenges arising from the psilocybin experience, with an emphasis on promoting adaptive cognitive and behavioral changes.
Follow-up assessments will occur via telehealth at 30 and 60 days post-psilocybin, with an in-person assessment conducted at 120 days. The final visit will include a urine drug screen.
540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 391 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →This is the only study on the registry with Kevin Murnane as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects whose laboratory blood tests demonstrate clinically significant abnormalities. Clinically acceptable ranges listed below:
Hemoglobin (Hb or Hgb):
Hematocrit (Hct):
For women: 35.5% - 44.9% White Blood Cell Count (WBC): 4,500 - 11,000 cells/µL Platelet Count: 150,000 - 450,000 cells/µL
Prohibited Medications If subjects have a history of taking the following medications, they should be discontinued at least 5 half-lives prior to administering psilocybin.
Participants will be administered 25mg of Psilocybin.
Drug: Psilocybin 25 mg
25 mg administered orally (capsules)
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: Screening, Visit #1
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: Baseline Assessments, Visit #2
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: Preparatory Session #1, Visit #3 (on study day (-)14; 14 days prior to dosing)
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: Preparatory Session #2, Visit #4 (on study day (-) 7; 7 days prior to dosing)
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: Preparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: Day of drug administration, Visit #6 (on study day 0)
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: 1-Day post drug administration integration session, Visit #7
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: 7-Day post drug administration integration session, Visit #8
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: 30-days post drug administration follow-up (Follow-up #1), Visit #9
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: 60-days post drug administration follow-up (Follow-up #2), Visit #10
Participant retention rate
Description: Retention in the study will be assessed by measuring the percentage of study visits completed per participant. Measure: * Retention rate (percent of scheduled study visits completed by each participant).
Time frame: 120-days post drug administration follow-up (Follow-up #3), Visit #11 (Final visit)
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Urine drug screen results (positive/negative for methamphetamine).
Time frame: Screening, Visit #1
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Urine drug screen results (positive/negative for methamphetamine).
Time frame: Day of drug administration, Visit #6 (on study day 0)
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Urine drug screen results (positive/negative for methamphetamine).
Time frame: 120 days post drug administration (Follow up #3), Visit #11(final visit)
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Timeline Followback (TLFB): Self-reported days of methamphetamine use in the past 30 days.
Time frame: Screening, Visit #1
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Timeline Followback (TLFB): Self-reported days of methamphetamine use in the past 30 days.
Time frame: 30 day post drug administration (Follow up #1), Visit #9
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Timeline Followback (TLFB): Self-reported days of methamphetamine use in the past 30 days.
Time frame: 60 day post drug administration (Follow up #2), visit #10
Preliminary efficacy of psilocybin on methamphetamine abstinence
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Timeline Followback (TLFB): Self-reported days of methamphetamine use in the past 30 days.
Time frame: 120 days post drug administration (Follow up #3), visit #11
Mystical experiences associated with psilocybin administration
Description: The subjective effects of psilocybin will be assessed using validated self-report questionnaires. Measure: * Mystical Experience Questionnaire (MEQ-30): Total score range = 0-150; higher scores indicate a more intense mystical experience.
Time frame: Day of drug administration, Visit #6 (on study day 0)
Challenging experiences associated with psilocybin administration
Description: The subjective effects of psilocybin will be assessed using validated self-report questionnaires. Measure: * Challenging Experience Questionnaire (CEQ): Total score range = 0-200; higher scores indicate a more challenging experience.
Time frame: Day of drug administration, Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Heart rate (beats per minute).
Time frame: Baseline - Visit #2
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Heart rate (beats per minute).
Time frame: Preparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Heart rate (beats per minute).
Time frame: Day of drug administration(hourly) - Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Heart rate (beats per minute).
Time frame: Post-session monitoring day of drug administration - Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Blood pressure (systolic/diastolic, mmHg).
Time frame: Baseline - Visit #2
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Blood pressure (systolic/diastolic, mmHg).
Time frame: Preparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Blood pressure (systolic/diastolic, mmHg).
Time frame: Day of drug administration(hourly) - Visit #6 (on study day 0)
Physiological responses to psilocybin administration
Description: The physiological effects of psilocybin will be monitored using cardiovascular measures collected before, during, and after drug administration. Measure: * Blood pressure (systolic/diastolic, mmHg).
Time frame: Post-session monitoring day of drug administration - Visit #6 (on study day 0)
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame: Baseline assessment, visit #2
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame: 30 day post drug administration (Follow up #1), Visit #9
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame: 60 day post drug administration (Follow up #2), Visit #10
Effects of psilocybin on quality of life
Description: Quality of life will be assessed using a validated self-report questionnaire. Measure: * Quality of Life Questionnaire (QOL): Score range = 14-70; higher scores indicate greater life satisfaction.
Time frame: 120 days post drug administration (Follow up #3), Visit #11
Effects of psilocybin on negative affect
Description: Symptoms of depression, anxiety, and stress will be assessed using a validated self-report scale. Measure: * Depression Anxiety and Stress Scale (DASS-21): Score range = 0-126; higher scores indicate more severe negative affect.
Time frame: Baseline assessment, Visit #2
Effects of psilocybin on negative affect
Description: Symptoms of depression, anxiety, and stress will be assessed using a validated self-report scale. Measure: * Depression Anxiety and Stress Scale (DASS-21): Score range = 0-126; higher scores indicate more severe negative affect.
Time frame: 30 day post drug administration (Follow up #1), Visit #9
Effects of psilocybin on negative affect
Description: Symptoms of depression, anxiety, and stress will be assessed using a validated self-report scale. Measure: * Depression Anxiety and Stress Scale (DASS-21): Score range = 0-126; higher scores indicate more severe negative affect.
Time frame: 60 day post drug administration (Follow up #2), visit #10
Effects of psilocybin on negative affect
Description: Symptoms of depression, anxiety, and stress will be assessed using a validated self-report scale. Measure: * Depression Anxiety and Stress Scale (DASS-21): Score range = 0-126; higher scores indicate more severe negative affect.
Time frame: 120 days post drug administration (Follow up #3), Visit #11
Effects of psilocybin on cognitive flexibility
Description: Cognitive flexibility will be assessed using a neuropsychological test that measures executive function and task-switching ability. Measure: * Trail Making Test (TMT Part B): Time to completion (seconds); shorter time indicates better executive function.
Time frame: Baseline, visit #2
Effects of psilocybin on cognitive processing speed
Description: Cognitive processing speed will be assessed using a standardized neuropsychological task. Measure: * Digit Symbol Substitution Task (DSST): Number of correct responses in 90 seconds; higher scores indicate better cognitive processing speed.
Time frame: 120 days post-drug administration (Follow Up #3), Visit #11.
Effects of psilocybin on inhibitory control
Description: Inhibitory control will be assessed using a validated cognitive task that measures response inhibition. Measure: * Stroop Color and Word Task: Reaction time (milliseconds); shorter reaction times indicate better inhibitory control.
Time frame: Baseline, visit #2
Effects of psilocybin on inhibitory control
Description: Inhibitory control will be assessed using a validated cognitive task that measures response inhibition. Measure: * Stroop Color and Word Task: Reaction time (milliseconds); shorter reaction times indicate better inhibitory control.
Time frame: 120 days post-drug administration (Follow Up #3), Visit #11
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.