RECRUITINGPhase 1INTERVENTIONAL
Effect of Cannabis on Cigarette Use Behavior
Effect of Cannabinoids on Tobacco Product Demand and Pharmacodynamics: Cigarette Use
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
THC 30mg
High dose of THC (30 mg)
DRUG
THC 5mg
Low dose of THC (5 mg)
DRUG
THC 0mg
Placebo dose of THC (0 mg)
DRUG
Cigarette Full Nicotine
Full nicotine cigarette
DRUG
Cigarette Reduced Nicotine
Reduced nicotine cigarette
Locations (1)
Johns Hopkins University Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States