Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Psilocybin-assisted treatment (experimental) and Nicotine Replacement Therapy (NRT) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 21 to 65 years old. Have given written informed consent. Have a high school level of education. Be a daily smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking. Agree to abstain from smoking and alcohol for 24-hours, and caffeine for 12-hours prior to MRI scanning (for MRI participants only).

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: epilepsy with history of seizures; insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia; currently taking psychoactive prescription medication on a regular basis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-09 with completion listed for 2023-05-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Prolonged Abstinence: Biologically Verified Cigarette Smoking Abstinence for 6 Months (time frame: From the target quit date to the 6-month follow up).

It also tracked 2 secondary outcomes, for example Prolonged Abstinence: Biologically Verified Cigarette Smoking Abstinence for 3 Months and Prolonged Abstinence: Biologically Verified Cigarette Smoking Abstinence for 12 Months.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 82 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.