Methamphetamine Use DisorderEarly Phase 1NCT06899594
Psilocybin for Methamphetamine Addiction
A Early Phase 1 study testing Psilocybin 25 mg in people with Methamphetamine Use Disorder, run by Kevin Murnane at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Psilocybin 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2025to Mar 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
LSU Health Shreveport
Shreveport, Louisiana, 71103
About this study
Official title: A Pilot Study in North Louisiana to Assess the Tolerability of Psilocybin as Well as Its Capacity to Promote Abstinence From Methamphetamine
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.
Read the detailed description
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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Psilocybin 25 mg
- Keywords
- Methamphetamine, Psilocybin, Psychedelics, Methamphetamine Use Disorder, Stimulant Use Disorder, Methamphetamine Addiction, Addiction, Substance Use Disorder, Abstinence
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mgDrug
25 mg administered orally (capsules)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Participants will be administered 25mg of Psilocybin. Receives: Drug: Psilocybin 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Post-session monitoring day of drug administration - Visit #6 (on study day 0)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 120 days post drug administration (Follow up #3), Visit #11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start4 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kevin Murnane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin Murnane, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Kevin S Murnane, PhD, Principal investigator, Louisiana State University Health Science Center Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899594
- Sponsor's protocol ID
- STUDY00002094
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No