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Questions and Answers

What is the primary aim of the RCT evaluating the efficacy of psilocybin-enhanced psychotherapy in patients with methamphetamine use disorder?

To compare psilocybin-enhanced psychotherapy to standard psychotherapy

To evaluate the long-term outcomes of psilocybin treatment

To assess the efficacy of psilocybin in treating methamphetamine use disorder

To assess the acceptability, feasibility, and safety of the intervention (correct)

Which of the following substances was not mentioned in the review as having studies evaluating the efficacy of psilocybin?

Benzodiazepines or hypnotics

Cocaine (correct)

Inhalants

Gambling

What is the main limitation of the studies included in the systematic review based on the quality assessment?

The studies had a serious to critical risk of bias (correct)

The studies were not randomized controlled trials

The studies did not assess long-term outcomes

The studies had a low sample size

Which of the following is the most accurate statement about the efficacy of psilocybin in substance use disorders based on the information provided in the text?

Psilocybin has been shown to be effective in treating alcohol and tobacco use disorders Signup and view all the answers

Based on the information provided, what is the most significant limitation in the generalizability of the findings from the studies included in this systematic review?

The studies did not include patients with a wide range of substance use disorders Signup and view all the answers

What was the primary outcome measured in the Johnson RCT involving psilocybin and opioids?

Difference in percentage days abstinent from opioids Signup and view all the answers

In the NCT05242029 non-randomized study, what intervention was given alongside two doses of psilocybin?

(Preparatory) counseling Signup and view all the answers

What was the key comparison in the P.Hendricks RCT involving psilocybin and cocaine?

Difference in complete sustained abstinence from cocaine Signup and view all the answers

Which study assessed the effect of psilocybin on methamphetamine use up to 2 months post discharge?

NCT02037126 Signup and view all the answers

What was a challenge highlighted in the text regarding clinical trials involving psilocybin?

Placebo response variability Signup and view all the answers

What is a potential challenge in clinical trials evaluating the efficacy of psilocybin for substance use disorders?

All of the above Signup and view all the answers

Based on the information provided, what can be inferred about the placebo response in the clinical trial evaluating ketamine for alcohol use disorder?

The placebo arm was included to separate the specific effects of ketamine from non-specific treatment effects. Signup and view all the answers

Which statement best reflects the generalizability of the findings from the clinical trials evaluating psychedelics for substance use disorders?

The generalizability of the findings is unclear and requires further research. Signup and view all the answers

What is a potential limitation of the available pharmacological interventions for substance use disorders?

They have high relapse rates in the long term. Signup and view all the answers

Based on the information provided, what can be inferred about the efficacy of ketamine in treating alcohol use disorder?

The efficacy of ketamine could not be determined due to the study design. Signup and view all the answers

What is the primary focus of the ongoing double-blind, placebo-controlled RCT mentioned in the text?

Exploring the effects of psilocybin on opioid use disorder in patients on methadone treatment Signup and view all the answers

Based on the study by Johnson et al., what percentage of patients were confirmed abstinent from smoking at the 26-week follow-up assessment?

80% Signup and view all the answers

Why was there no assessment of psilocybin efficacy in patients with cocaine use disorder according to the text?

Insufficient evidence supporting psilocybin efficacy in treating cocaine use disorder Signup and view all the answers

What was the primary intervention used in the study by Johnson et al. to assist smoking cessation?

Cognitive behavioral therapy sessions Signup and view all the answers

What aspect of the ongoing RCT mentioned in the text indicates a potential challenge in generalizing results to a broader population?

Inclusion criteria focusing on multiple past quit attempts Signup and view all the answers

What was the primary outcome measure in the randomized clinical trial examining psilocybin-assisted psychotherapy for alcohol use disorder?

Percentage of heavy drinking days Signup and view all the answers

Which of the following statements accurately summarizes the findings of the study by Wilkinson et al. on the impact of midazolam on ketamine trials?

Midazolam reduced the effect size estimates of ketamine's rapid antidepressant effects compared to saline. Signup and view all the answers

Which of the following statements accurately describes the findings of the early studies by Rydzyński et al. on the use of psychedelic drugs in the treatment of alcoholism?

The studies reported promising preliminary results but lacked rigorous methodology and follow-up data. Signup and view all the answers

Based on the study by Grabski et al., which of the following statements is true regarding the use of ketamine in combination with psychological therapy for alcohol use disorder?

The study did not include a psychological therapy-only control group, so the added benefit of ketamine could not be determined. Signup and view all the answers

What was the primary purpose of the study by Szigeti et al. on self-blinding citizen science and psychedelic microdosing?

To develop a citizen science approach for conducting self-blinded placebo-controlled trials of psychedelic microdosing. Signup and view all the answers

What is a potential challenge in double-blind, placebo-controlled randomized controlled trials (RCTs) evaluating psychedelics like psilocybin?

Maintaining masking (blinding) is usually unsuccessful, which may result in an increased effect size for the efficacy of psilocybin. Signup and view all the answers

What is the significance of comparing psilocybin to an approved active pharmacological treatment in patients with substance use disorder (SUD), as mentioned in the text?

It is essential to understand how psilocybin compares to approved pharmacological treatments and its effect size in comparative efficacy trials. Signup and view all the answers

What potential factor could influence the expectancy of patients with tobacco use disorder regarding the efficacy of psilocybin, and thus affect the study results?

Having a past use of psychedelics, which could influence their expectations. Signup and view all the answers

According to the meta-analysis by Wilkinson et al. (39) evaluating the efficacy of ketamine for major depressive disorder or bipolar disorder, what factor significantly reduced the observed effect size?

The use of an inactive placebo (saline) instead of an active placebo (midazolam). Signup and view all the answers

Despite the potential challenges in maintaining blinding in psychedelic trials, what observation did Bogenschutz et al. (26) make regarding the efficacy of psilocybin?

They observed a medium effect size for the efficacy of psilocybin, despite comparing it to an active placebo. Signup and view all the answers

What was the greatest reduction in alcohol use observed in the study?

Ketamine + psychotherapy group vs. placebo + alcohol education Signup and view all the answers

Which aspect was deemed 'critical' in the quality assessment of Rydzyński et al.'s study?

Overall risk of bias Signup and view all the answers

What is likely to be part of the eventual treatment strategy according to the text?

Psilocybin combined with psychotherapy Signup and view all the answers

Which group had the lowest reduction in alcohol use based on the study results?

Placebo + alcohol education group Signup and view all the answers

What intervention showed a mean difference of 15.9 in reducing alcohol use according to the study?

Ketamine + psychotherapy Signup and view all the answers

Which study had 'some concerns' regarding deviations from intended interventions?

Bogenschutz et al. Signup and view all the answers

In which group was the placebo combined with alcohol education according to the text?

(Therapy control) group Signup and view all the answers

'Low' risk of bias was observed in which aspect of Bogenschutz et al.'s study?

Randomization process Signup and view all the answers

'Serious' risk of bias was noted in which aspect of Johnson et al.'s study?

'Serious' risk in overall risk of reported results bias Signup and view all the answers

What is needed to derive meaning from psilocybin sessions and change substance use behavior?

Combination of psilocybin and psychotherapy Signup and view all the answers

Study Notes

Psilocybin Treatment for Substance Use Disorders (SUD)

Psilocybin is being compared to an approved active pharmacological treatment for the first time in patients with SUD.
Maintaining masking in double-blind, placebo-controlled RCTs evaluating psychedelics is usually unsuccessful, which may result in an increased effect size for the efficacy of psilocybin.

Efficacy of Psilocybin in SUD

Four clinical trials assessing the efficacy of psilocybin in SUD were identified, with three trials in patients with alcohol use disorder and one trial in patients with tobacco use disorder.
One of the trials was a double-blind, placebo-controlled RCT, while the other three trials were single-arm pilot studies with a substantial risk of bias.

Psilocybin and Tobacco Use Disorder

One study by Johnson et al. was included, assessing the efficacy of psilocybin-assisted therapy in patients with tobacco use disorder.
The intervention consisted of three psilocybin sessions and four cognitive behavioral therapy sessions.
At 26-week follow-up, 80% of patients were abstinent from smoking, and at 52-week follow-up, 67% of patients were confirmed abstinent from smoking.

Psilocybin and Cocaine Use Disorder

No studies were identified evaluating the efficacy of psilocybin in patients with cocaine use disorder.
A pilot double-blind, placebo-controlled RCT assessing the efficacy of psilocybin for cocaine use disorder is currently recruiting participants.

Quality Assessment of Studies

The risk of bias has been assessed in three non-randomized trials and one randomized clinical trial.
The three non-randomized trials were assessed as having a serious to critical risk of bias, and the randomized clinical trial was assessed as having some concerns of risk of bias.

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Description

Explore the evaluation of adjunctive ketamine in patients with alcohol use disorder through a double-blind, placebo-controlled Randomized Controlled Trial (RCT) with different treatment arms. Understand the treatment effects of ketamine combined with psychotherapy and alcohol education compared to placebo treatments.