Effect of Cannabis on Cigarette Use Behavior (NCT06609083) | Clinical Trial Compass
RecruitingPhase 1
Effect of Cannabis on Cigarette Use Behavior
United States100 participantsStarted 2025-01-22
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Demand Intensity
Timeframe: 45 minutes after THC or placebo administration
2
Demand Elasticity
Timeframe: 45 minutes after THC or placebo administration
✕. 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)