THC Clinical Trial - Understanding the Clinical Pharmacology of

Status Not yet recruiting

Clinical Trial Summary

This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.

Clinical Trial Description

This is a single-center, within-subject (crossover), randomized, double-blinded clinical pharmacology study of over 8 study visits (days). Participants will be non-treatment-seeking, healthy frequent users of both marijuana and tobacco/nicotine, age 21 to 65 years (21 years because of California tobacco control law). Participants will be marijuana users of any race who smoke or vape marijuana or THC extracts at least three days a week for the past 3 months or more. The study investigators will use positive urine toxicology THC results and self-report of marijuana smoking/vaping to determine eligibility. Participants must also be current users of inhaled forms of tobacco/nicotine (cigarettes, cigars, e-cigarettes) who use the product daily over the past 3 months. Each study day will consist of a standardized session of 5 puffs of one of 8 study conditions using a PAX-3 vaporizer (PAX Labs, Inc.). Blood will be sampled multiple times for plasma THC, nicotine, and catecholamines, questionnaires administered for sensory and subjective effects, and heart rate, skin blood flow, and skin temperature will be measured. After 6 hours of abstinence, participants will have 60 minutes of ad libitum access to the assigned study condition, during which heart rate and blood pressure will be continuously monitored, blood sampled before and after for THC, nicotine, and platelet aggregation measured, and questionnaires administered. Studies will be conducted at the CTSI Clinical Research Services-supported research ward at Zuckerberg San Francisco General. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05999383
Study type	Interventional
Source	University of California, San Francisco
Contact	Armando Barraza
Phone	6282064226
Email	armando.barraza@ucsf.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	October 31, 2023
Completion date	October 31, 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Recruiting	`NCT06033599` - Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement	Phase 3
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT06105424` - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability	N/A
Completed	`NCT01311830` - Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons	N/A
Completed	`NCT04566198` - Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
Completed	`NCT04107779` - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS	N/A
Completed	`NCT05092919` - The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults	Early Phase 1
Terminated	`NCT05274217` - Journey of Transformation Curriculum for Native American Adolescents	N/A
Enrolling by invitation	`NCT06042361` - Enhancing Equity in Smoke-free Housing	N/A
Completed	`NCT03235713` - EMA for Tobacco Control Policy Research
Withdrawn	`NCT03352635` - Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core	N/A
Completed	`NCT03151421` - Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home	N/A
Completed	`NCT03446170` - Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers	N/A
Completed	`NCT04104152` - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting	N/A
Recruiting	`NCT04429568` - THC Crossover Study	N/A
Completed	`NCT04632030` - Shrinking the Size of the Tobacco Power Wall	N/A
Completed	`NCT04143256` - Evaluating Selected Constituents in the Exhaled Breath Samples	N/A
Completed	`NCT04094363` - CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration — CANNIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms