Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder
Study Details
Study Description
Brief Summary
This pilot study will collect preliminary data that measures the effects of psychedelic-assisted psychotherapy on patients struggling with alcohol use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Psilocybin Group (PG) receives individual psychotherapy sessions plus a (30 mg) psilocybin session. |
Drug: Psilocybin
1 30mg dose
|
| No Intervention: Control Group (CG) receives psychotherapy only, with open-label access option at the end of their study involvement. |
Outcome Measures
Primary Outcome Measures
- Timeline Follow-Back for Alcohol to assess change [weekly, over the course of 8 weeks]
quantifies daily alcohol use
Eligibility Criteria
Criteria
Inclusion Criteria:
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English fluency
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Meets criteria for DSM-V Alcohol Use Disorder (AUD)
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Have at least 4 heavy drinking days in the past 30 days
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Not currently participating in formal treatment for alcohol dependence
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At least a high-school level of education or equivalent (e.g. GED).
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Currently using an effective method of contraception (females).
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Family member/friend for pick-up, overnight post-psilocybin session monitoring.
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Agree to maintain normal caffeine intake (coffee, tea) on day of psilocybin session. No caffeine use on day of session if not routinely used.
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Agree not to take any "as needed" medications on the mornings of drug sessions
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Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
Exclusion Criteria:
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Pregnant or lactating
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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)
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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).
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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.).
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MRI contraindication (pacemaker, copper IUD, etc.)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peggy C Nopoulos
Investigators
- Principal Investigator: Peggy C Nopoulos, MD, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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;:.
- 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. Review.
- 202205036