RecruitingPhase 1NCT06609083

Effect of Cannabis on Cigarette Use Behavior

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


Sponsor

Johns Hopkins University

Enrollment

100 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria9

  • 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.

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Interventions

DRUGTHC 30mg

High dose of THC (30 mg)

DRUGTHC 5mg

Low dose of THC (5 mg)

DRUGTHC 0mg

Placebo dose of THC (0 mg)

DRUGCigarette Full Nicotine

Full nicotine cigarette

DRUGCigarette Reduced Nicotine

Reduced nicotine cigarette


Locations(1)

Johns Hopkins University Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

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NCT06609083


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