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
Effectiveness Progress
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
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: DrugNiacin
Drug
ActiveComparator Group · 1 Intervention: Niacin · Intervention Types: DrugTrial 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?
| Indiana | 50.0% |
| Maryland | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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
| 100.0% | |
References
- Ross, Stephen, Anthony Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara Malone, Barry Cohen, Sarah E Mennenga, et al.. 2016. “Rapid and Sustained Symptom Reduction Following Psilocybin Treatment for Anxiety and Depression in Patients with Life-threatening Cancer: A Randomized Controlled Trial”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881116675512.
- Johnson MW, Garcia-Romeu A, Cosimano MP, Griffiths RR. Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. J Psychopharmacol. 2014 Nov;28(11):983-92. doi: 10.1177/0269881114548296. Epub 2014 Sep 11.
- Grob, Charles S., Alicia L. Danforth, Gurpreet S. Chopra, Marycie Hagerty, Charles R. McKay, Adam L. Halberstadt, and George R. Greer. 2011. “Pilot Study of Psilocybin Treatment for Anxiety in Patients with Advanced-stage Cancer”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archgenpsychiatry.2010.116.
- Johnson MW, Garcia-Romeu A, Griffiths RR. Long-term follow-up of psilocybin-facilitated smoking cessation. Am J Drug Alcohol Abuse. 2017 Jan;43(1):55-60. doi: 10.3109/00952990.2016.1170135. Epub 2016 Jul 21. Erratum in: Am J Drug Alcohol Abuse. 2017 Jan;43(1):127.
- Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z, Corby P, Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016 Dec;30(12):1165-1180. doi: 10.1177/0269881116675512.
- Johnson MW, Garcia-Romeu A, Griffiths RR. Long-term follow-up of psilocybin-facilitated smoking cessation. Am J Drug Alcohol Abuse. 2017 Jan;43(1):55-60. doi: 10.3109/00952990.2016.1170135. Epub 2016 Jul 21. Erratum In: Am J Drug Alcohol Abuse. 2017 Jan;43(1):127.
- 2023. "5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05452772.
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Conditions
Cancer Related
Treatments