Psilocybin for Tobacco Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tobacco Use DisorderNiacin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Three sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart.

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 12 months

12 months
Potential Efficacy (Smoking Cessation)
Prolonged Abstinence
Day 1
Cognitive control (Multi-Source Interference Task) at Visit 5
Smoking Urges (Questionnaire on Smoking Urges; Factor 2) at Visit 5
Day 2
Cognitive control (Multi-Source Interference Task) at Visit 6
Smoking Urges (Questionnaire on Smoking Urges; Factor 2) at Visit 6
Week 4
Cognitive control (Multi-Source Interference Task) at Screening (Visit 0)
Smoking Urges (Questionnaire on Smoking Urges; Factor 2) at Screening

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Psilocybin
1 of 2
Niacin
1 of 2

Active Control

66 Total Participants · 2 Treatment Groups

Primary Treatment: Psilocybin · No Placebo Group · Phase 2

Psilocybin
Drug
ActiveComparator Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Niacin
Drug
ActiveComparator Group · 1 Intervention: Niacin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,432 Previous Clinical Trials
2,219,008 Total Patients Enrolled
5 Trials studying Tobacco Use Disorder
759 Patients Enrolled for Tobacco Use Disorder
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,159 Total Patients Enrolled
16 Trials studying Tobacco Use Disorder
4,283 Patients Enrolled for Tobacco Use Disorder
New York UniversityOTHER
205 Previous Clinical Trials
313,698 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
585 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,245 Previous Clinical Trials
5,619,334 Total Patients Enrolled
255 Trials studying Tobacco Use Disorder
47,654 Patients Enrolled for Tobacco Use Disorder
Matthew W Johnson, Ph.DPrincipal InvestigatorJohns Hopkins University School of Medicimne
Matthew Johnson, Ph.DPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Indiana50.0%
Maryland50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "This was suggested by my therapist. I've tried hypnosis, cold turkey, and other ways with no success."
How many prior treatments have patients received?
3+100.0%

How responsive is this trial?

Typically responds via
Email100.0%
References