Psilocybin treatment to help stop methamphetamine use
A Pilot Study in North Louisiana to Assess the Tolerability of Psilocybin as Well as Its Capacity to Promote Abstinence From Methamphetamine
This pilot will try a single 25 mg dose of psilocybin in people in residential treatment for methamphetamine use to see if it helps them stay abstinent, reduce craving, improve mood, and support cognitive function.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Louisiana State University Health Sciences Center Shreveport Academic / other |
| Locations | 1 site (Shreveport, Louisiana) |
| Trial ID | NCT06899594 on ClinicalTrials.gov |
What this trial studies
This open-label pilot gives a single 25 mg dose of psilocybin to participants recruited from a local residential treatment facility and follows them through 10–12 visits over up to six months. Eligibility requires adults 25–65 who identify methamphetamine as their drug of choice and have recent use and a desire to quit; screening includes psychiatric interview, medical history, and labs. The protocol includes three preparatory sessions (two may be via telehealth), the dosing session with session monitors, and post-dosing integration visits, with outcomes measured for abstinence, craving, negative affect, cognition, quality of life, and components of the psychedelic experience. Feasibility and tolerability will be tracked through retention rates, safety labs, and reported challenging experiences.
Who should consider this trial
Good fit: Adults aged 25–65 who are currently at the designated residential treatment facility in Northern Louisiana, identify methamphetamine as their drug of choice, used methamphetamine in the month before admission, meet dependence severity thresholds, want to achieve abstinence, and have limited recent psychedelic exposure.
Not a fit: People outside the age range, not enrolled at the designated treatment facility, not motivated to stop methamphetamine use, with recent psychedelic use, or with medical/psychiatric exclusions are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option that helps people stop methamphetamine use and reduces craving, negative mood, and cognitive deficits associated with dependence.
How similar studies have performed: Small psilocybin trials have shown promise for tobacco and alcohol use disorders, but using psilocybin for methamphetamine addiction is largely novel and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shreveport, Louisiana
- LSU Health Shreveport — Shreveport, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Kevin S Murnane, PhD — Louisiana State University Health Science Center Shreveport
- Study coordinator: Kevin S Murnane, PhD
- Email: kevin.murnane@lsuhs.edu
- Phone: (318) 675-7830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.