RecruitingEarly Phase 1NCT06899594

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

Sponsor

Kevin Murnane

Enrollment

20 participants

Start Date

Apr 4, 2025

Study Type

INTERVENTIONAL

Conditions

Methamphetamine Use Disorder

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.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Inclusion Criteria12

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 Criteria33

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