Status:
RECRUITING
Effect of Cannabis on E-Cigarette Use Behavior
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use
Tobacco Use
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are...
Detailed 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 electronic cigarettes...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy non-treatment seeking adults aged 21 or older
- Report daily use of e-cigarettes
- Biological confirmation of e-cigarette use: have an expired carbon monoxide (CO) level of less than 6 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
- 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.
Exclusion
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06609109
Start Date
March 19 2025
End Date
October 1 2029
Last Update
April 2 2025
Active Locations (1)
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1
Johns Hopkins University Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224