Clinical TrialSubstance Use Disorders (SUD)PsilocybinPlaceboCompleted

Psilocybin-facilitated Treatment for Cocaine Use

Randomised, double-blind, parallel-group Phase II trial (n=40) comparing a single oral psilocybin dose (0.36 mg/kg) versus diphenhydramine 100 mg with CBT-based preparation and integration in adults seeking to stop cocaine use; includes MRI assessments.

Target Enrollment
40 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, parallel-group trial (n=40) testing psilocybin (0.36 mg/kg oral, single 8-hour session) against an active comparator (diphenhydramine 100 mg) for treatment of cocaine use disorder with CBT-based preparation and integration.

Unique features include pre- and post-treatment 3T MRI and MRS to assess changes in default mode network connectivity and Glx in the anterior cingulate cortex and hippocampus as potential mediators of clinical effects.

Participants receive four weekly 2-hour preparation CBT sessions, the dosing session with two therapists present, an ~1-hour meeting within 2 days for initial integration and safety assessment, then weekly 1-hour integration sessions for four weeks, plus 3- and 6-month follow-ups.

Study Protocol

Preparation

4 sessions
120 min each

Dosing

1 sessions
480 min each

Integration

5 sessions
60 min each

Therapeutic Protocol

cbt

Study Arms & Interventions

Psilocybin

experimental

Single oral psilocybin session (0.36 mg/kg) with preparatory CBT and integration.

Interventions

  • Psilocybin0.36 mg/kg
    via Oral• single dose• 1 doses total

    Single oral dose administered during an 8-hour session; paired with CBT preparation and integration.

Diphenhydramine

active comparator

Active placebo comparator: oral diphenhydramine 100 mg in single session.

Interventions

  • Placebo100 mg
    via Oral• single dose• 1 doses total

    Diphenhydramine 100 mg oral (active comparator / control).

Participants

Ages
25 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 25 years of age and older
  • Score of at least 3 on the Severity of Dependence Scale
  • Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence questionnaire
  • Ability to read/write in English
  • No prior hallucinogen use or it will have been at least 3 years since their last use of a hallucinogen
  • Availability of a friend or family member into whose care the participant can be released following their drug administration session.
  • In good general health as assessed by detailed medical history and physical examination
  • Abstinence from cocaine for at least 7 days prior to experimental drug administration as confirmed via urinalysis and no signs of intoxication on other drugs.

Exclusion Criteria

  • Exclusion Criteria:
  • 24 years of age and younger
  • Women who are pregnant or breast feeding
  • Current psychiatric diagnoses other than substance abuse/dependence
  • Current hypertension (exceeding 140 systolic and 90 diastolic at resting as described below)
  • Use of tricyclic antidepressants, lithium, Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors, haloperidol, St. John's Wort, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity
  • History of any psychotic disorders
  • History of bipolar I or II disorder
  • First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders
  • Current suicidal or homicidal ideation
  • Planning to move from the Birmingham area in the next 6 months
  • Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)

Study Details

Locations

UAB Outpatient Clinical Research Unit — Birmingham, Alabama, United States

Your Library