Effect of Cannabis on Cigarette Use Behavior

Last updated: January 15, 2026
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

1

Condition

Substance Abuse

Treatment

THC 30mg

THC 0mg

Cigarette Full Nicotine

Clinical Study ID

NCT06609083
IRB00435111
R01DA058624
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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) levelof 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 atscreening.

  7. For women of children bearing potential and men with female partners ofchild-bearing potential, must be willing to use an effective form of contraceptionduring the study.

Exclusion

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 disorderother 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 negativelyimpact participant safety or scientific integrity

  6. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or currentsuicidal behavior or ideation as assessed by the Columbia Suicide Severity RatingScale (C-SSRS)

  7. Are currently pregnant, planning to become pregnant in the next three months or arecurrently 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 partof a research study within 30 days of study participation.

Study Design

Total Participants: 100
Treatment Group(s): 5
Primary Treatment: THC 30mg
Phase: 1
Study Start date:
January 22, 2025
Estimated Completion Date:
October 01, 2029

Study 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.

Connect with a study center

  • Johns Hopkins University Behavioral Pharmacology Research Unit

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Johns Hopkins University Behavioral Pharmacology Research Unit

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Active - Recruiting

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