Clinical Trials Logo

Clinical Trial Summary

This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Assess pharmacokinetic (PK)/pharmacodynamic (PD) profiles of THC vaping liquids administered with co-use of vaped nicotine. II. Outcomes of interest will be assessed overall, and according to biological sex. SECONDARY OBJECTIVES: I. Safety. II. Assessment of differences in puffing behaviors. III. Short-term subjective drug effects, and cognitive performance following THC use without nicotine versus (vs.) THC use with pre-nicotine use vs. THC use with post-nicotine use in current consumers of both vaped cannabis and vaped nicotine products. OUTLINE: Participants are randomized to 1 of 3 arms. ARM A: Participants complete 3 vaping sessions separated by 7-14 days on study: - VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. - VISIT 2: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. - VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. ARM B: Participants complete 3 vaping sessions separated by 7-14 days on study: - VISIT 1: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. - VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. - VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. ARM C: Participants complete 3 vaping sessions separated by 7-14 days on study: - VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. - VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. - VISIT 3: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial. After completion of study intervention, participants are followed up at 30 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06334016
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Not yet recruiting
Phase Early Phase 1
Start date March 27, 2025
Completion date March 1, 2028

See also
  Status Clinical Trial Phase
Completed NCT01005810 - A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana Phase 2
Completed NCT00114439 - Lithium Cannabis Withdrawal Study Phase 2
Completed NCT00350285 - The Teen Marijuana Check-Up Phase 2
Completed NCT01618656 - Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal Phase 2
Completed NCT01153490 - Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine Phase 4
Completed NCT02946489 - Facilitating the Behavioral Treatment of Cannabis Use Disorder Phase 1
Completed NCT02088177 - Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence Phase 1/Phase 2
Not yet recruiting NCT01565174 - The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis N/A
Completed NCT01697709 - Quetiapine Pharmacotherapy for Cannabis Dependence Phase 2
Recruiting NCT04721353 - Reducing Cannabis Overuse With Prazosin Phase 4
Completed NCT01603992 - Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms
Completed NCT00167297 - Atomoxetine for the Treatment of Cannabis Dependence Phase 2
Terminated NCT01598896 - Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia Phase 2/Phase 3
Completed NCT01611948 - Treatment for Cannabis Withdrawal and Dependence Phase 2
Recruiting NCT03221231 - N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms Phase 4
Not yet recruiting NCT03366909 - Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness N/A
Completed NCT01639872 - Clozapine for Cannabis Use in Schizophrenia Phase 4
Completed NCT01793961 - Effects of Chronic Intake of Cannabis on Contrast Sensitivity N/A
Completed NCT01747850 - Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence Phase 2
Completed NCT01834794 - Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders N/A