Health TrialsbyHealthPanel

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

ConditionTobacco Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

21 years old or older

Be a daily smoker (minimum of 5 cigarettes/day on a typical day and breath CO of 6 or greater at screening) with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking

Read, write, and speak English

Agree to abstain from smoking for the psilocybin/niacin session from 1 hour before psilocybin/niacin administration until at least 8 hours afterward

Disqualifiers

The use of e-cigarettes or tobacco products other than machine-manufactured combustible cigarettes (e.g., cigarillos) on more than 5 of the previous 30 days

Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control

Positive urine drug screen for illicit drugs (excluding cannabis)

Positive urine breath test for alcohol. Participants with positive tests will be rescheduled

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    Participants will received two psilocybin sessions, 1 week apart

  • Niacin

    Drug

    Participants will received two niacin sessions, 1 week apart

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: PsilocybinActive comparator 1 intervention
Group B: NiacinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Potential Efficacy (Smoking Cessation)

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 objective and biological measure of smoking over approximately the past 24 hours; and (3) urinary cotinine level, an additional biological and objective measure of nicotine exposure and allows for detection of smoking or other nicotine product use over the previous six days. Though these measures are not study outcomes individually, they will verify 7-day point prevalence abstinence at 12-month follow-up - the primary outcome. Specifically, 0 cigarettes reported on the TLFB, breath CO of ≤6 ppm, and urine cotinine levels of \<200ng/mL will be considered smoking abstinence.

Time frame
12 months

Secondary outcomes

1

Prolonged Abstinence

A secondary measure of abstinence will be prolonged abstinence, defined as no smoking at all after the target quit date, with the exception that smoking lapses during an initial 2-week grace period after the target quit date are not counted.

Time frame
12 months
2

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

The Multi-Source Interference Task is a measure of cognitive control that requires participants to inhibit a prepotent response when engaged in a voluntary task-based action. The Multi-Source Interference Task will be administered at screening - approximately 4 weeks prior to the first psilocybin / niacin session (i.e., 4 weeks prior to the target quit date), and again at Visits 5 and 6.

Time frame
Approximately 4 weeks prior to the target quit date
3

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

The Multi-Source Interference Task is a measure of cognitive control that requires participants to inhibit a prepotent response when engaged in a voluntary task-based action. The Multi-Source Interference Task will be administered at Visit 5 - 1 day after the first psilocybin / niacin session (i.e., 1 day after the target quit date), and again at Visit 6.

Time frame
Approximately 1 day after the target quit date
4

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

The Multi-Source Interference Task is a measure of cognitive control that requires participants to inhibit a prepotent response when engaged in a voluntary task-based action. The Multi-Source Interference Task will be administered at Visit 6, the day of the second psilocybin / niacin session (i.e., 2 days after the target quit date).

Time frame
Approximately 2 days after the target quit date

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

University of Alabama at Birmingham

Collaborator

New York University

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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