quantifies daily alcohol use
Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
Brief 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.
Condition or Disease
- Alcohol Use Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Not yet recruiting |
| Study results: | No Results Available |
| Age: | 25 Years to 50 Years |
| Enrollment: | 20 (ESTIMATED) |
| Allocation: | Randomized |
| Primary Purpose: | Basic Science |
Masking |
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Clinical Trial Dates
| Start date: | Oct 01, 2023 | ESTIMATED |
|---|---|---|
| Primary Completion: | Oct 01, 2024 | ESTIMATED |
| Completion Date: | Oct 01, 2024 | ESTIMATED |
| Study First Posted: | Jun 16, 2022 | ACTUAL |
| Last Updated: | Aug 27, 2023 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
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.
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.
Participant Groups
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receives individual psychotherapy sessions plus a (25 mg) psilocybin session.
-
receives individual psychotherapy sessions plus a (200 mg) ketamine session with open-label access option at the end of their study involvement.
Eligibility Criteria
| Sex: | Male |
|---|---|
| Minimum Age: | 25 |
| Maximum Age: | 50 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 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.)
* 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.)
Primary Outcomes
Secondary Outcomes
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Measures biological changes in the brain
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Measures biological changes in the brain
Other Outcomes
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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
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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)
More Details
| NCT Number: | NCT05421065 |
|---|---|
| Other IDs: | 202205036 |
| Study URL: | https://clinicaltrials.gov/study/NCT05421065 |
Last updated: Sep 29, 2023