NCT06899594 · Kevin Murnane
Psilocybin for Methamphetamine Addiction
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Psilocybin 25 mg
25 mg administered orally (capsules)
Primary outcome measures
Participant retention rate
Time frame: Screening, 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 rate
Time frame: Baseline 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 rate
Time frame: Preparatory 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 rate
Time frame: Preparatory 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 rate
Time frame: Preparatory 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 rate
Time frame: Day 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 rate
Time frame: 1-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 rate
Time frame: 7-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 rate
Time frame: 30-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 rate
Time frame: 60-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 rate
Time frame: 120-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 abstinence
Time frame: Screening, 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 abstinence
Time frame: Day 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 abstinence
Time frame: 120 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 abstinence
Time frame: Screening, 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 abstinence
Time frame: 30 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 abstinence
Time frame: 60 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 abstinence
Time frame: 120 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 administration
Time frame: Day 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 administration
Time frame: Day 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 administration
Time frame: Baseline - 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 administration
Time frame: Preparatory 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 administration
Time frame: Day 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 administration
Time frame: Post-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 administration
Time frame: Baseline - 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 administration
Time frame: Preparatory 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 administration
Time frame: Day 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 administration
Time frame: Post-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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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 Hemoglobin (Hb or Hgb):
- For men: 13.8 - 17.2 g/dL
- For women: 12.1 - 15.1 g/dL Hematocrit (Hct):
- 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. 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.
- 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
Where
- Shreveport, Louisiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2025 · Source of record for eligibility and locations