Psilocybin for Methamphetamine Addiction

This study is looking at whether psilocybin (25 mg), given as a single dose, can help people stop using methamphetamine. Researchers want to see if this treatment is practical and well-tolerated in people with methamphetamine use disorder, especially in Northern Louisiana. They will measure how many people stay in the study, how much they crave methamphetamine, their mood, thinking abilities, and overall quality of life. You might be able to join if you are 25-65 years old, identify methamphetamine as your main drug of choice, have been in a treatment facility for at least 7 days, and have used methamphetamine in the past month. The study aims to enroll 20 participants.

Study design: This is an open-label pilot study, meaning everyone knows what treatment they are receiving. It will involve about 20 participants.
What's involved: You would attend 10 to 12 study visits over a period of up to six months. This includes screening, baseline assessments, three preparatory sessions, and the psilocybin dosing session.
Compensation: Not stated in the trial record.
Follow-up: Not specified in the trial record.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Psilocybin for Methamphetamine Addiction

Recruiting

EARLY_PHASE1Ages 25–65InterventionalTreatment

Kevin Murnane

~20 participants

Updated 2025-10-07 on ClinicalTrials.gov

What's tested:Psilocybin 25 mg

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Participant retention rate

Measured over Screening, Visit #1

+27 more outcomes measured

Conditions

Methamphetamine Use Disorder

Where it's being run

1 sites across 1 states

Louisiana1

Study leadership

Kevin S Murnane, PhD · PRINCIPAL_INVESTIGATOR · Louisiana State University Health Science Center Shreveport

Who to contact

Kevin S Murnane, PhD

[email protected]

(318) 675-7830

Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

Plans to move away from Shreveport-Bossier area in the next 6 months

Subjects whose laboratory blood tests demonstrate clinically significant abnormalities. Clinically acceptable ranges listed below:

Complete Blood Count (CBC) Red Blood Cell Count (RBC): 4.5 - 6.0 million cells/µL

For men: 13.8 - 17.2 g/dL

For women: 12.1 - 15.1 g/dL

For men: 38.3% - 48.6%

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

Blood Chemistry with Liver Function Tests Alanine Transaminase (ALT): 7 - 56 units/L Aspartate Transaminase (AST): 8 - 48 units/L Bilirubin (Total): 0.2 - 1.2 mg/dL

Renal Function Tests Blood Urea Nitrogen (BUN): 7 - 20 mg/dL Creatinine: 0.6 - 1.3 mg/dL

If there are abnormalities, or if the results are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant, or indicative of an unstable medical condition.

Medications that antagonize the serotonin 2A receptor

Medications with serotonergic activity (e.g., SSRIs, SNRIs, efavirenz, lithium)

Medications that inhibit UGT1A9 or UGT1A10 enzymes

Monoamine Oxidase Inhibitors (MAOIs)

Medications that inhibit aldehyde or alcohol dehydrogenase

What this trial measures

Participant retention rateScreening, Visit #1
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).
Participant retention rateBaseline Assessments, Visit #2
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).
Participant retention ratePreparatory Session #1, Visit #3 (on study day (-)14; 14 days prior to dosing)
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).
Participant retention ratePreparatory Session #2, Visit #4 (on study day (-) 7; 7 days prior to dosing)
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).
Participant retention ratePreparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
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).
Participant retention rateDay of drug administration, Visit #6 (on study day 0)
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).
Participant retention rate1-Day post drug administration integration session, Visit #7
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).
Participant retention rate7-Day post drug administration integration session, Visit #8
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).
Participant retention rate30-days post drug administration follow-up (Follow-up #1), Visit #9
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).
Participant retention rate60-days post drug administration follow-up (Follow-up #2), Visit #10
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).
Participant retention rate120-days post drug administration follow-up (Follow-up #3), Visit #11 (Final visit)
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).
Preliminary efficacy of psilocybin on methamphetamine abstinenceScreening, Visit #1
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Urine drug screen results (positive/negative for methamphetamine).
Preliminary efficacy of psilocybin on methamphetamine abstinenceDay of drug administration, Visit #6 (on study day 0)
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Urine drug screen results (positive/negative for methamphetamine).
Preliminary efficacy of psilocybin on methamphetamine abstinence120 days post drug administration (Follow up #3), Visit #11(final visit)
Description: Methamphetamine abstinence will be assessed using both objective and self-reported substance use measures. Measure: * Urine drug screen results (positive/negative for methamphetamine).
Preliminary efficacy of psilocybin on methamphetamine abstinenceScreening, Visit #1
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.
Preliminary efficacy of psilocybin on methamphetamine abstinence30 day post drug administration (Follow up #1), Visit #9
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.
Preliminary efficacy of psilocybin on methamphetamine abstinence60 day post drug administration (Follow up #2), visit #10
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.
Preliminary efficacy of psilocybin on methamphetamine abstinence120 days post drug administration (Follow up #3), visit #11
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.
Mystical experiences associated with psilocybin administrationDay of drug administration, Visit #6 (on study day 0)
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.
Challenging experiences associated with psilocybin administrationDay of drug administration, Visit #6 (on study day 0)
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.
Physiological responses to psilocybin administrationBaseline - Visit #2
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).
Physiological responses to psilocybin administrationPreparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
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).
Physiological responses to psilocybin administrationDay of drug administration(hourly) - Visit #6 (on study day 0)
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).
Physiological responses to psilocybin administrationPost-session monitoring day of drug administration - Visit #6 (on study day 0)
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).
Physiological responses to psilocybin administrationBaseline - Visit #2
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).
Physiological responses to psilocybin administrationPreparatory Session #3, Visit #5 (on study day (-)3; 3 days prior to dosing)
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).
Physiological responses to psilocybin administrationDay of drug administration(hourly) - Visit #6 (on study day 0)
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).
Physiological responses to psilocybin administrationPost-session monitoring day of drug administration - Visit #6 (on study day 0)
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).

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