Effect of Cannabis on Cigarette Use Behavior

Effect of Cannabinoids on Tobacco Product Demand and Pharmacodynamics: Cigarette Use

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use; Cannabis Use; Cigarette Smoking
• Intervention / Treatment: Drug: THC 0mg; Drug: THC 30mg; Drug: THC 5mg; Drug: Cigarette Full Nicotine; Drug: Cigarette Reduced Nicotine

Detailed Description

A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of combustible cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on combustible tobacco use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dustin Lee, PhD; Phone Number: 410-550-4035; Email: dlee214@jhmi.edu
• Study Contact Backup: Name: Lauren Brogdon, MHS; Phone Number: 410-550-6953; Email: lmorri20@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins University Behavioral Pharmacology Research Unit
      • Principal Investigator: Dustin Lee, PhD
      • Contact: Lauren Morris, MHS; Phone Number: 410-550-6953; Email: lmorri20@jhmi.edu
      • Contact: Dustin Lee, PhD; Phone Number: 410-550-4035; Email: dlee214@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: THC 0mg; Placebo dose of THC (0 mg); Drug: THC 30mg; High dose of THC (30 mg); Drug: THC 5mg; Low dose of THC (5 mg); Drug: Cigarette Full Nicotine; Full nicotine cigarette; Drug: Cigarette Reduced Nicotine; Reduced nicotine cigarette
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.	Drug: THC 0mg; Placebo dose of THC (0 mg); Drug: THC 30mg; High dose of THC (30 mg); Drug: THC 5mg; Low dose of THC (5 mg); Drug: Cigarette Full Nicotine; Full nicotine cigarette; Drug: Cigarette Reduced Nicotine; Reduced nicotine cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demand Intensity	Consumption of cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).	45 minutes after THC or placebo administration
Demand Elasticity	Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).	45 minutes after THC or placebo administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minnesota Nicotine Withdrawal Scale (MNWS)	A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1	Self report assessment smoking urges. Factor 1 - Intention/Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2	Self report assessment smoking urges. Factor 2 - Relief of Negative Affect & Urgent Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Drug Effect Questionnaire for Like Drug	The Drug Effect Questionnaire will be administered using a visual analog scale. Participants place a mark on a 100mm line with the left endpoint labeled Not at All and the right endpoint labeled Extremely. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Heart Rate	Heart rate will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Diastolic Blood Pressure	Diastolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Systolic Blood Pressure	Systolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Divided Attention Task (DAT) Performance	Participants will complete a Divided Attention Task (DAT) in which the participant must simultaneously track a stimulus moving horizontally on a computer screen and respond to visual stimuli presented. The primary dependent measure is the average distance maintained from the target stimulus. Primary outcomes will be the peak change from baseline.	Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Dustin Lee, PhD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cannabis; tobacco; THC; marijuana; cigarette
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Smoking; Marijuana Abuse; Cigarette Smoking; Tobacco Use; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: IRB00435111; R01DA058624 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No