Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Primary Outcomes

• Acceptability End of 6-week intervention; approximately 42 days

  We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.

• Proportion of patients who complete the intervention and follow-up End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days

  We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.

Secondary Outcomes

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 180 day post-discharge follow-up; approximately 222 days post-enrollment

  Number of Participants Who Experienced Treatment-related Adverse Events as defined by the FDA (21 Code of Federal Regulations \[CFR\] 312.32(a)). Adverse events assessed at every study visit by clinical observation and patient interview.

• Methamphetamine Use, self-report 60 days post-discharge follow-up; approximately 102 days post-enrollment

  Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.

• Methamphetamine Use, self-report 180 days post-discharge follow-up; approximately 222 days post-enrollment

  Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.

• Methamphetamine Use, urine 60 days post-discharge follow-up; approximately 102 days post-enrollment

  Urine drug screen

• Methamphetamine Use, urine 180 days post-discharge follow-up; approximately 222 days post-enrollment

  Urine drug screen

• Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention approximately 42 days post-enrollment

  Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired).

• Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up approximately 102 days post-enrollment

  Sheehan Disability Scale total score, a measure of clinician-rated functional impairment

• Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up approximately 222 days post-enrollment

  Sheehan Disability Scale total score, a measure of clinician-rated functional impairment

Other Outcomes

• Change from baseline in Stimulant Craving at end-of-intervention approximately 42 days post-enrollment

  Stimulant Craving Questionnaire-Brief

• Change from baseline in Stimulant Craving at 60 day post-discharge follow-up approximately 102 days post-enrollment

  Stimulant Craving Questionnaire-Brief

• Change from baseline in Stimulant Craving at 180 day post-discharge follow-up approximately 222 days post-enrollment

  Stimulant Craving Questionnaire-Brief

• Change from baseline in Depression Symptoms at end-of-intervention approximately 42 days post-enrollment

  Beck Depression Inventory-II

• Change from baseline in Depression Symptoms at 60 day post-discharge follow-up approximately 102 days post-enrollment

  Beck Depression Inventory-II

• Change from baseline in Depression Symptoms at 180 day post-discharge follow-up approximately 222 days post-enrollment

  Beck Depression Inventory-II

• Change from baseline in PTSD Symptoms at end-of-intervention approximately 42 days post-enrollment

  PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5

• Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up approximately 102 days post-enrollment

  PTSD Checklist for DSM-5

• Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up approximately 222 days post-enrollment

  PTSD Checklist for DSM-5

• Change from baseline in Anxiety Symptoms at end-of-intervention approximately 42 days post-enrollment

  Measured by Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 (minimal anxiety) to 21 (severe anxiety).

• Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up approximately 102 days post-enrollment

  Generalized Anxiety Disorder-7

• Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up approximately 222 days post-enrollment

  Generalized Anxiety Disorder-7

• Change from baseline in Attachment Insecurity at end-of-intervention approximately 42 days post-enrollment

  Experiences in Close Relationships-Short form

• Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up approximately 102 days post-enrollment

  Experiences in Close Relationships-Short form

• Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up approximately 222 days post-enrollment

  Experiences in Close Relationships-Short form

• Change from baseline in Immune Markers at end-of-intervention approximately 42 days post-enrollment

  C-Reactive Protein, Interleukin (IL)-6, Tumor Necrosis Factor (TNF)-a, IL-8, IL-10, IL-1β, CCL2, CCL3

• Change from baseline in Heart Rate Variability at end-of-intervention approximately 42 days post-enrollment

  heart rate variability, 7 minutes, resting