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Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05421065
Recruitment Status : Not yet recruiting
First Posted : June 16, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Peggy C Nopoulos, University of Iowa

Tracking Information
First Submitted Date  ICMJE June 12, 2022
First Posted Date  ICMJE June 16, 2022
Last Update Posted Date July 21, 2022
Estimated Study Start Date  ICMJE November 2022
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2022)
Timeline Follow-Back for Alcohol to assess change [ Time Frame: weekly, over the course of 8 weeks ]
quantifies daily alcohol use
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2022)
Timeline Follow-Back (TLFB) for Alcohol [ Time Frame: weekly, over the course of 8 weeks ]
quantifies daily alcohol use
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder
Official Title  ICMJE Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder
Brief Summary This pilot study will collect preliminary data that measures the effects of psychedelic-assisted psychotherapy on patients struggling with alcohol use.
Detailed Description

The study design will be a randomized trial where Arm 1 will receive individual psychotherapy sessions plus a psilocybin session (n=10, Psilocybin Group or PG). Arm 2 will receive psychotherapy only (n=10, Control Group or CG).

At baseline, subjects will be consented, randomized into one of the two arms, complete psychiatric and medical evaluations, and will undergo a 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, the PG will undergo an 6-8 hour psilocybin-assisted therapy session. The last 2 psychotherapy sessions will be focused on integration of their experiences in the psilocybin session. For the CG, the last 2 sessions will be continued psychotherapy. Therefore, each arm receives 4 psychotherapy sessions. The difference is that the PG group receives an additional session, where they receive psilocybin. 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 follow-up MRI scan, and a final assessment. At the conclusion of the study, those randomized to the CG 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE Drug: Psilocybin
1 30mg dose
Study Arms  ICMJE
  • Experimental: Psilocybin Group (PG)
    receives individual psychotherapy sessions plus a (30 mg) psilocybin session.
    Intervention: Drug: Psilocybin
  • No Intervention: Control Group (CG)
    receives psychotherapy only, with open-label access option at the end of their study involvement.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peggy C Nopoulos, MD 319-356-1144 peggy-nopoulos@uiowa.edu
Contact: Erin Golden 319-359-9072 lindsay-golden@uiowa.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05421065
Other Study ID Numbers  ICMJE 202205036
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Peggy C Nopoulos, University of Iowa
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Peggy C Nopoulos
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peggy C Nopoulos, MD University of Iowa
PRS Account University of Iowa
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP