NCT04429568

THC Crossover Study

Cardiovascular Effects of Cannabis Compared to Tobacco Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.

Detailed description

Experienced dual cannabis-tobacco smokers will participate in a within-subject crossover study with three blocks: smoked cannabis (purchased by participants from a local dispensary), dry herb cannabis vaporizer, and usual brand tobacco cigarette. Each block will consist of 2 consecutive days on an inpatient research ward. The first inpatient day of each block will comprise of two sessions: (1) The first session will be a standardized bout to compare pharmacokinetic, physiologic, and subjective effects of cannabis and tobacco use; (2) after 6 hours of abstinence, the second session will be ad libitum access to the assigned product for 2 hours to compare subjective effects (reward, satisfaction, craving reduction) and use patterns. The second inpatient day will consist of ad libitum use of the assigned product from 8:00 in the morning to midnight. An abstinence day will be added after the second day of the last block to assess exposure and effects biomarkers during a period of abstinence from cannabis (smoked/vaped) or tobacco.

Conditions

• THC
• Cannabis
• Cannabis Smoking
• Cannabis Use, Unspecified
• Cigarette Smoking
• Tobacco Use
• Nicotine Dependence
• Nicotine Withdrawal
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
OTHER	Smoked Cannabis	Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
OTHER	Vaped Cannabis	Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
OTHER	Tobacco Cigarette	Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.

Timeline

• Start date: 2020-10-30
• Primary completion: 2024-06-25
• Completion: 2024-06-25
• First posted: 2020-06-12
• Last updated: 2024-07-01

Locations

2 sites across 1 country: United States