Actively Recruiting

Early Phase 1
Age: 25Years - 65Years
All Genders
NCT06899594

Psilocybin for Methamphetamine Addiction

Led by Kevin Murnane · Updated on 2025-10-07

20

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Psilocybin for Methamphetamine Addiction

Who Can Participate

Age: 25Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 25 to 65 years at time of informed consent
  • Methamphetamine is the drug of choice
  • Score of 3 or higher on the Severity of Dependence Scale
  • Have been at the designated local treatment facility for at least 7 days
  • Used methamphetamine in the month before admission to the treatment center
  • Desire to stop methamphetamine use aiming for complete abstinence
  • English speaking, as all neuropsychological tasks are in English
  • No psychedelic use or at least 3 years since last psychedelic use
  • Able to attend two telehealth and one in-person preparatory sessions
  • Able to attend two telehealth integration sessions and three follow-up assessments
  • Diagnosed with Stimulant Use Disorder - Amphetamine type, with no other substance dependence except nicotine or cannabis
  • In acute remission from methamphetamine for at least 7 days before drug administration, confirmed by self-report and urine drug screen
Not Eligible

You will not qualify if you...

  • Dependence on other substances besides methamphetamine, nicotine, or cannabis
  • History of Hallucinogen Use Disorder or Hallucinogen Persisting Perceptive Disorder
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Women not agreeing to abstinence or not using dual contraception during the study
  • Current hypertension exceeding 140/90 mmHg at screening or pre-dosing
  • Heart rate below 60 bpm or above 100 bpm at screening or pre-dosing
  • QTc interval less than 350 msec or greater than 460 msec
  • History of cardiovascular or cerebral vascular disease (except controlled hypertension)
  • Unstable medical or psychiatric conditions as determined by psychiatrist
  • Diagnosis of schizophrenia or type 1 bipolar disorder
  • Recent or current suicidal thoughts in last 6 months
  • Taking prohibited medications or unwilling/unable to stop them
  • History of significant brain injury or seizure disorder
  • Inability to understand informed consent or study materials
  • Moderate to severe liver impairment
  • Planning to move away from Shreveport-Bossier area within 6 months
  • Significant abnormalities in blood tests outside defined clinical ranges
  • Medications antagonizing serotonin 2A receptor, serotonergic drugs, UGT1A9/10 inhibitors, MAOIs, or aldehyde/alcohol dehydrogenase inhibitors not discontinued at least 5 half-lives before dosing

AI-Screening

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Trial Site Locations

Total: 1 location

1

LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

Actively Recruiting

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Research Team

K

Kevin S Murnane, PhD

CONTACT

J

John A Vanchiere, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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