NCT05452772 is a Phase 2 clinical trial of Psilocybin in Tobacco Use Disorder, sponsored by Johns Hopkins University.

Who is sponsoring NCT05452772?

NCT05452772 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT05452772?

Interventions in NCT05452772: Psilocybin, Niacin.

What condition does NCT05452772 study?

NCT05452772 studies Tobacco Use Disorder.

Is NCT05452772 still recruiting?

NCT05452772 is currently recruiting now. Last updated 25 July 2025.

Last reviewed 2025-07-25 · How we verify

NCT05452772

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Recruiting now Phase 2 Last updated 25 July 2025

What this trial tests

Phase 2 trial testing Psilocybin in Tobacco Use Disorder in 66 participants. Currently enrolling.

Timeline

1 November 2023

Primary endpoint
1 December 2026

1 May 2027

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	1 November 2023
Primary completion	1 December 2026
Estimated completion	1 May 2027
Sites	3 locations across United States

Drugs / interventions tested

Psilocybin — full drug profile →
Niacin (NIACIN) — full drug profile →

Conditions studied

Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

Johns Hopkins University

Who can join

21 and older, any sex, with Tobacco Use Disorder. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Potential Efficacy (Smoking Cessation)
Time frame: 12 months
Smoking cessation will be dichotomously coded 7-day point prevalence abstinence at 12-month follow-up. This binary outcome (abstinent versus non-abstinent) will be verified via three measures of recent smoking-(1) timeline follow-back (TLFB), a self-report calendar completed retrospectively by participants indicating the number of cigarettes smoked each day; (2) exhaled carbon monoxide (CO), an ob

Sponsor's own description

This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic effect of psilocybin in addiction: A systematic review.
van der Meer PB, Fuentes JJ, Kaptein AA, Schoones JW, et al · · 2023 · cited 55× · PMID 36846225 · DOI 10.3389/fpsyt.2023.1134454
Exploring psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder.
Brett J, Knock E, Korthuis PT, Liknaitzky P, et al · · 2023 · cited 11× · PMID 36998623 · DOI 10.3389/fpsyt.2023.1123424
Psychedelics as a potential treatment for tobacco use disorder: a systematic review.
Spoelstra SK, Schoevers RA, Venema SD, Knegtering H. · · 2024 · cited 3× · PMID 39289250 · DOI 10.1007/s44192-024-00095-0
Licit use of illicit drugs for treating depression: the pill and the process.
Torrado Pacheco A, Moghaddam B. · · 2024 · cited 2× · PMID 40047885 · DOI 10.1172/jci180217
Emerging medications and pharmacological treatment approaches for substance use disorders.
Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, et al · · 2025 · cited 2× · PMID 39719161 · DOI 10.1016/j.pbb.2024.173952

Verify or expand the search:

Other trials of Psilocybin

Trials testing the same drug.

NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting
NCT07226232 — Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression · Phase 3 · not yet recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT07506395 — Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder · Phase 1 · not yet recruiting

Other recruiting trials for Tobacco Use Disorder

Currently open trials in the same condition.

NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
NCT06678672 — Contingency Management for Veteran Smokers Undergoing Major Elective Surgery · NA · recruiting
NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
NCT06798324 — tDCS Plus Varenicline for Smoking Cessation · Phase 4 · recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05452772 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 25 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05452772.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing