Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421065
• Other study ID #: 202205036
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: University of Iowa
• Contact: Peggy C Nopoulos, MD
• Phone: 319-356-1144
• Email: peggy-nopoulos[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This pilot study will be a double blind, randomized, active-comparator controlled trial with two study arms. Subjects randomized to Arm 1 (n=10) will receive individual psychotherapy sessions plus a 25mg dose of psilocybin, while Arm 2 subjects (n=10) will receive individual psychotherapy sessions and a 200mg dose of ketamine. Psychotherapy sessions will involve integrative psychotherapy modalities.

At baseline, subjects will be consented, randomized into one of the two arms, complete psychiatric and medical evaluations, and will undergo an MRI scan. The first two therapy sessions (week 1 and week 2) will be used to learn about the participant's life story, engage the patient, and evoke their reasons for wanting to change their pattern of alcohol use. At week 3, participants will undergo a psilocybin-assisted therapy session or a ketamine-assisted therapy session. The last 2 psychotherapy sessions will be focused on integration of their experiences in the drug administration session and will include a second MRI scan and more assessments. Therefore, each arm receives 4 psychotherapy sessions, and the primary difference between the groups is which drug participants receive. After the psychotherapy sessions are completed at the end of week 4, subjects will be followed weekly for 4 weeks. At the last follow-up (week 8), they will undergo a third MRI scan and a final assessment. At the conclusion of the study, those randomized to the ketamine group will be offered a psilocybin-assisted therapy session, and two follow-up/integration sessions in an open-label extension. The open-label extension will also include an additional 4 weeks of follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male

• English fluency

• Meets criteria for DSM-V moderate to severe 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

• No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history

• No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes

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

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

• Psilocybin and ketamine naïve

• No self-reported, personal, or familial history of specific psychotic disorders/episodes

• No serious traumatic brain injury (TBI) in the past 2 years

• No known allergies to diazepam (rescue medication)

• Weight between 50kg and 150 kg

Exclusion Criteria:

• Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, 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, or benzodiazepines).

• Psychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use including cocaine, psychostimulant, or opioid use disorder within past 12 months and/or any use within past 30 days, 5) history of co-occurring psychotic episode/diagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and/or serious personality disorders amongst other conditions.

• Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc > .045]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function).

• MRI contraindication (pacemaker, etc.)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Psilocybin
1 25mg oral dose
• Ketamine
1 200mg oral dose

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Peggy C Nopoulos

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13. — View Citation

Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285. Erratum In: JAMA Psychiatry. 2021 Feb 10;: — View Citation

Johnson M, Richards W, Griffiths R. Human hallucinogen research: guidelines for safety. J Psychopharmacol. 2008 Aug;22(6):603-20. doi: 10.1177/0269881108093587. Epub 2008 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility and acceptability of the protocol	Measure study's rate of attrition by recording the number of participants who withdraw from the study or are discharged from the study before completion	1 year
Other	Feasibility and acceptability of the protocol	Measure frequency and nature of adverse events (AEs) through recording total number of AEs and their severity on a scale of mild to moderate to severe (1-3 scale with 3 being the worst outcome)	1 year
Primary	Timeline Follow-Back for Alcohol to assess change	quantifies daily alcohol use	weekly, over the course of 8 weeks
Secondary	T1rho	Measures biological changes in the brain	three times (before intervention, immediately after intervention, and 4 weeks-post intervention)
Secondary	Resting state fMRI	Measures biological changes in the brain	three times (before intervention, immediately after intervention, and 4 weeks-post intervention)