What side effects are associated with this type of intervention?

Common treatments for Tobacco Use Disorder include pharmacotherapies like varenicline, bupropion, and nicotine replacement therapy (NRT). Varenicline can cause nausea, insomnia, and abnormal dreams, and has been associated with neuropsychiatric symptoms in some cases. Bupropion may lead to insomnia, dry mouth, and an increased risk of seizures. Nicotine replacement therapies, such as patches, gums, and lozenges, can cause local irritation, insomnia, and vivid dreams. Psilocybin, a 5-HT2A receptor agonist, is being studied for smoking cessation and may cause transient anxiety, nausea, and perceptual changes during administration.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of Tobacco Use Disorder, including varenicline, bupropion, and various forms of nicotine replacement therapy (NRT) such as patches, gum, and lozenges. Varenicline works by partially stimulating nicotine receptors and reducing withdrawal symptoms, while bupropion is an atypical antidepressant that also helps reduce cravings and withdrawal symptoms. Nicotine replacement therapies provide a controlled dose of nicotine to ease withdrawal. These treatments differ from psilocybin, a 5-HT2A receptor agonist currently under investigation, which may offer a novel mechanism of action for smoking cessation by potentially altering mood and perception to reduce the desire to smoke.

What other types of research exist?

Promising alternatives to psilocybin for Tobacco Use Disorder include: 1) Antidepressants such as nortriptyline and bupropion, which have been studied for smoking cessation. 2) Varenicline, a partial agonist at the nicotinic acetylcholine receptor, which has shown efficacy in multiple trials. 3) Nicotine Replacement Therapy (NRT) in various forms (patches, gum, lozenges) which is well-established for smoking cessation. These alternatives have demonstrated efficacy in clinical trials and are viable options for patients considering treatment in 2024.

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Other

Psilocybin for Quitting Smoking

Phase 2

Recruiting

Led By Matthew Johnson, Ph.D

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial tests psilocybin, a compound from mushrooms, to help smokers quit. It targets smokers because past studies showed good results. Psilocybin affects brain receptors to improve mood and reduce cravings, potentially making it easier to stop smoking. Psilocybin has shown promise in previous studies for promoting long-term smoking abstinence when combined with therapy.

Who is the study for?

This trial is for adults over 21 who smoke daily (at least 5 cigarettes/day) and have tried to quit multiple times without success. Participants must be in good health as confirmed by medical exams, not use other tobacco products or psychoactive drugs, including alcohol, before sessions. Pregnant or nursing women and those with certain mental health conditions or cardiovascular issues are excluded.

What is being tested?

The study tests the effectiveness of psilocybin, a psychedelic compound, against niacin in helping people stop smoking. It's double-blind and randomized: participants won't know which treatment they receive during two sessions spaced one week apart at three research sites.

What are the potential side effects?

Psilocybin can cause changes in perception, mood swings, nausea, headache, increased heart rate and blood pressure. Niacin might lead to skin flushing, itching or gastrointestinal upset. The severity of side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Potential Efficacy (Smoking Cessation)

Secondary study objectives

Cognitive control (Multi-Source Interference Task) at Screening (Visit 0)

Cognitive control (Multi-Source Interference Task) at Visit 5

Cognitive control (Multi-Source Interference Task) at Visit 6

+4 more

Trial Design

2Treatment groups

Active Control

Group I: PsilocybinActive Control1 Intervention

30 mg in session 1 and either 30 mg or 40 mg in session 2, with sessions 1 week apart. Dosing will be based on participants' responses to the Mystical Experiences Questionnaire (MEQ30), taken at the end of their first session. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 30 mg of psilocybin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 40 mg for the second session.

Group II: NiacinActive Control1 Intervention

150 mg in session 1 and either 150 mg or 200 mg in session 2, with sessions 1 week apart. Dosing will be based on participants' responses to the Mystical Experiences Questionnaire (MEQ30), taken at the end of their first session. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 150 mg niacin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 200 mg niacin for the second session.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tobacco Use Disorder include varenicline, bupropion, and nicotine replacement therapy (NRT). Varenicline works by partially stimulating nicotinic receptors in the brain, reducing cravings and withdrawal symptoms while blocking the rewarding effects of nicotine. Bupropion is an atypical antidepressant that inhibits the reuptake of norepinephrine and dopamine, which helps to reduce withdrawal symptoms and the urge to smoke. NRT provides a controlled dose of nicotine to ease withdrawal symptoms and reduce the urge to smoke. These mechanisms are crucial as they address both the physical dependence on nicotine and the psychological aspects of addiction. Psilocybin, a 5-HT2A receptor agonist, is being studied for its potential to alter perception and cognition, which may help in breaking the addiction cycle by providing new insights and reducing the psychological grip of nicotine dependence.

Find a Location

Who is running the clinical trial?

Sheppard Pratt Health SystemOTHER

22 Previous Clinical Trials

7,778 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,307 Previous Clinical Trials

14,861,843 Total Patients Enrolled

18 Trials studying Tobacco Use Disorder

4,147 Patients Enrolled for Tobacco Use Disorder

University of Alabama at BirminghamOTHER

1,621 Previous Clinical Trials

2,290,912 Total Patients Enrolled

5 Trials studying Tobacco Use Disorder

759 Patients Enrolled for Tobacco Use Disorder

Media Library

Niacin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05452772 — Phase 2

Tobacco Use Disorder Research Study Groups: Psilocybin, Niacin

Tobacco Use Disorder Clinical Trial 2023: Niacin Highlights & Side Effects. Trial Name: NCT05452772 — Phase 2

Niacin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452772 — Phase 2

Tobacco Use Disorder Patient Testimony for trial: Trial Name: NCT05452772 — Phase 2

~26 spots leftby May 2025

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