Psilocybin for Methamphetamine Addiction
A Pilot Study in North Louisiana to Assess the Tolerability of Psilocybin as Well as Its Capacity to Promote Abstinence From Methamphetamine
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2025
CompletedStudy Start
First participant enrolled
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
October 7, 2025
March 1, 2025
1.9 years
November 27, 2024
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (28)
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
Post-session monitoring day of drug administration - Visit #6 (on study day 0)
Secondary Outcomes (8)
Effects of psilocybin on quality of life
Baseline assessment, visit #2
Effects of psilocybin on quality of life
30 day post drug administration (Follow up #1), Visit #9
Effects of psilocybin on quality of life
60 day post drug administration (Follow up #2), Visit #10
Effects of psilocybin on quality of life
120 days post drug administration (Follow up #3), Visit #11
Effects of psilocybin on negative affect
Baseline assessment, Visit #2
- +3 more secondary outcomes
Other Outcomes (4)
Effects of psilocybin on cognitive flexibility
Baseline, visit #2
Effects of psilocybin on cognitive processing speed
120 days post-drug administration (Follow Up #3), Visit #11.
Effects of psilocybin on inhibitory control
Baseline, visit #2
- +1 more other outcomes
Study Arms (1)
Psilocybin
EXPERIMENTALParticipants will be administered 25mg of Psilocybin.
Interventions
Eligibility Criteria
You may qualify if:
- Age 25-65 at time of signing informed consent
- Identification of methamphetamine as drug of choice
- Score of at least 3 on the Severity of Dependence Scale
- Have been at the designated local treatment facility for at least 7 days
- Use of methamphetamine in the month preceding admission to the treatment center
- Desire to cease methamphetamine use as indicated by a goal of complete methamphetamine abstinence on the Thoughts about Abstinence questionnaire
- All English speakers, as all neuropsychological tasks will be given in English
- No prior psychedelic use or it will have been at least 3 years since their last use of a psychedelic
- Ability to attend two telehealth and one in person preparatory session appointments to establish comfort, trust and rapport between subjects and the research team and discuss the subjects' goals and aspirations with regard to the psilocybin administration.
- Ability to attend two integration sessions via telehealth and 3 follow-up assessments in person and via telehealth.
- Diagnosis of Stimulant Use Disorder - Amphetamine type on the MINI (Mini International Neuropsychiatric Interview), with no other substance dependence diagnoses other than nicotine or cannabis
- In acute remission from methamphetamine for at least 7 days prior to experimental drug administration as assessed by self-report and confirmed by urine drug screen (UDS) as well as the lack of any acute signs of intoxication on psychoactive drugs other than nicotine
You may not qualify if:
- Meeting criteria for substance dependence diagnoses other than methamphetamine (except nicotine and cannabis) as assessed by the MINI
- History of Hallucinogen Use Disorder or Hallucinogen Persisting Perceptive Disorder
- Women who are pregnant, plan to become pregnant, or are breast feeding
- Women who do not agree to engage in abstinence or are not using dual contraceptive methods at the time of enrollment and for the study duration
- Current hypertension (exceeding 140 systolic and 90 diastolic at resting as described below) at screening or during vitals taken pre-dosing
- Heart rate of less than 60 bpm and greater than 100 bpm at screening or during vitals taken pre-dosing
- QTc of less than 350 msec or more than 460 msec
- History of cardiovascular disease (other than controlled hypertension) or cerebral vascular disease
- Unstable medical or psychiatric conditions or disorders as determined at the discretion of the attending psychiatrist
- Clear diagnosis of schizophrenia or type 1 bipolar disorder (clear from confusion with drug-induced acute states)
- Having current or recent (last 6 months) suicidal ideation, assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Subjects currently taking medications on the prohibited medications list or that are unwilling/unable to cease medication
- History of significant brain injury or seizure disorder
- Inability to understand the informed consent, study purpose and procedures, or other study materials involved in the research study
- Those with moderate to severe hepatic impairment, as assessed by laboratory parameters.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kevin Murnanelead
Study Sites (1)
LSU Health Shreveport
Shreveport, Louisiana, 71103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin S Murnane, PhD
Louisiana State University Health Science Center Shreveport
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 27, 2024
First Posted
March 28, 2025
Study Start
April 4, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
October 7, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share