org355: Psychedelics for alcohol

1. What is the PICO for the new study?

2. How is the intervention allocated?

4. Comment on the blinding/masking aspect of the control arm.

4. What inputs are required to get the sample size of 280?

5. What is the hypothesised mediating factor / mechanism of action?

6. Does clinical equipoise exist for this study to be proposed?

7. If you're on the ethics board which reviews this study, what questions would you have for the researchers?

This should be it for Epi in the News in 2022. Next year I'll send on articles, though less regularly, and perhaps without questions. I hope you've enjoyed these articles, and have learned to read the newspaper with a bit more a critical eye.

Re: Psychedelics for alcohol

by | JUDITH MARGARET BURCHARDT - Friday, 13 January 2023, 11:11 PM

Thank you for the link to this intriguing trial Sujit.

1. What is the PICO for the new study?

Population - severe alcohol use disorder patients
Intervention - high dose ketamine - 3 injections
Control - low dose ketamine - 3 injections
Outcome - abstinence from alcohol

2. How is the intervention allocated?

randomisation - I assume blinded to observers and they hope blinded to participants too

4. Comment on the blinding/masking aspect of the control arm.

It may be optimistic to think that somebody who has an out of body experience or epiphany doesn't realise they are in the high dose arm. Likewise, people who just feel relaxed are likely to guess that they are in the low dose arm. It is possible that some participants will have had prior experience of taking ketamine.

4. What inputs are required to get the sample size of 280?

Estimate of the risk ratio for the effectiveness of high:low dose ketamine.
Estimate of the proportion of people abstinent at 6 months in the low dose ketamine group.
The researchers will also have to decide what type I and type II error rates they think are acceptable

5. What is the hypothesised mediating factor / mechanism of action?

growth of new synapses in the brain allowing new ways that pts can think about alcohol

6. Does clinical equipoise exist for this study to be proposed?

Yes, I think so - there is some evidence that ketamine is effective, but it hasn't always worked as expected.

7. If you're on the ethics board which reviews this study, what questions would you have for the researchers?

I would be concerned of introducing people who already have one addiction to another addictive drug. Will they end up becoming addicted to ketamine too?

Judith

Judith