Recruiting
Phase 1

THC

Sponsor:

Johns Hopkins University

Code:

NCT06609083

Conditions

Cannabis Use

Tobacco Use

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

THC 30mg

THC 5mg

THC 0mg

Cigarette Full Nicotine

Cigarette Reduced Nicotine

Study Details

Brief summary:

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.

Conditions

Cannabis Use

Tobacco Use

Cigarette Smoking

Study ID

NCT06609083

Start date

Jan 22, 2025

Status verified date

Jan, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy non-treatment seeking adults aged 21 or older
2. Report daily use of combustible tobacco cigarettes
3. Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 5 ppm and a positive urine cotinine test at screening
4. Report current use of cannabis (at least 1 occasion per week)
5. Have experience with the inhalation route of administration for cannabis
6. Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
7. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study.

Exclusion Criteria:

1. Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
2. Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
3. Test positive for illicit drugs other than cannabis and tobacco
4. Positive breath alcohol test at study admission
5. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
6. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
7. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
8. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
9. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Smoked THC

Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.

experimental: Vaporized THC

Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.

Interventions

THC 30mg

High dose of THC (30 mg)

THC 5mg

Low dose of THC (5 mg)

THC 0mg

Placebo dose of THC (0 mg)

Cigarette Full Nicotine

Full nicotine cigarette

Cigarette Reduced Nicotine

Reduced nicotine cigarette

Primary outcome measure

  • Demand Intensity [ Time Frame: 45 minutes after THC or placebo administration ]
  • Demand Elasticity [ Time Frame: 45 minutes after THC or placebo administration ]

Central Contacts and Locations

Central contacts

Locations

Johns Hopkins University Behavioral Pharmacology Research Unit

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Principal Investigator:

Dustin Lee, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • cannabis
  • cigarette
  • marijuana
  • THC
  • tobacco

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-16.