Effect of Cannabis on Cigarette Use Behavior

NCT06609083 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00435111R01DA058624
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

cannabis; cigarette; marijuana; THC; tobacco

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Minnesota Nicotine Withdrawal Scale (MNWS)

  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

  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

  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

  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

  Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.

Study Arms (2)

Smoked THC

EXPERIMENTAL

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 30mg; Drug: THC 5mg; Drug: THC 0mg; Drug: Cigarette Full Nicotine; Drug: Cigarette Reduced Nicotine

Vaporized THC

EXPERIMENTAL

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 30mg; Drug: THC 5mg; Drug: THC 0mg; Drug: Cigarette Full Nicotine; Drug: Cigarette Reduced Nicotine

Interventions

THC 30mg DRUG

High dose of THC (30 mg)

Smoked THC; Vaporized THC

THC 5mg DRUG

Low dose of THC (5 mg)

Smoked THC; Vaporized THC

THC 0mg DRUG

Placebo dose of THC (0 mg)

Smoked THC; Vaporized THC

Cigarette Full Nicotine DRUG

Full nicotine cigarette

Smoked THC; Vaporized THC

Cigarette Reduced Nicotine DRUG

Reduced nicotine cigarette

Smoked THC; Vaporized THC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy non-treatment seeking adults aged 21 or older
• Report daily use of combustible tobacco cigarettes
• 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
• Report current use of cannabis (at least 1 occasion per week)
• Have experience with the inhalation route of administration for cannabis
• Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
• 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.

You may not qualify if:

• Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
• Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
• Test positive for illicit drugs other than cannabis and tobacco
• Positive breath alcohol test at study admission
• Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
• 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)
• Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
• Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
• Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use; Cigarette Smoking; Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Smoking; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Dustin Lee, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Brogdon, MHS

CONTACT

410-550-6953; lmorri20@jhmi.edu

Dustin Lee, PhD

CONTACT

410-550-4035; dlee214@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)