Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study will collect preliminary data that measures the effects of psychedelic-assisted psychotherapy on patients struggling with alcohol use.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peggy C Nopoulos
• Treatments: Psilocybin

Criteria

Inclusion Criteria:

• English fluency

• Meets criteria for DSM-V Alcohol Use Disorder (AUD)

• Have at least 4 heavy drinking days in the past 30 days

• Not currently participating in formal treatment for alcohol dependence

• At least a high-school level of education or equivalent (e.g. GED).

• Currently using an effective method of contraception (females).

• Family member/friend for pick-up, overnight post-psilocybin session monitoring.

• Agree to maintain normal caffeine intake (coffee, tea) on day of psilocybin session. No caffeine use on day of session if not routinely used.

• Agree not to take any "as needed" medications on the mornings of drug sessions

• Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.

Exclusion Criteria:

• Pregnant or lactating

• Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, psychoactive drug use (including nicotine) within 24 hours of drug administration (the exception is caffeine), current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants)

• Psychiatric assessment that yields: increased risk of suicidality, family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives), hallucinogen use disorder (or any use in the past 1 year, or >25 lifetime uses), cocaine, psychostimulant, opioid, or cannabis use disorder within past 12 months and/or any use within past 30 days, co-occurring psychiatric conditions: (i.e. schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, current post-traumatic stress disorder, current suicidality or history of medically serious suicide attempt), high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).

• Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation, etc.), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation per investigator (seizure disorder, significantly impaired liver function, coronary artery disease, heart failure, uncontrolled hypertension, history of cerebrovascular accident, asthma, significant alcohol withdrawal history, etc.).

• MRI contraindication (pacemaker, copper IUD, etc.)