Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06334016
Other study ID # I-3597023
Secondary ID NCI-2024-01556I-
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date March 27, 2025
Est. completion date March 1, 2028

Study information

Verified date March 2024
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 1, 2028
Est. primary completion date March 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Age = 21 years of age; (self-reported on screening, verified at study visit). - Report use of commercial THC vaping cartridges for at least 3 months prior to enrollment; (self-reported). - Experience with THC potency at or above the study product AND experience with chasing THC with nicotine (at least monthly); (self-reported). - Report use of THC vaping liquids at least weekly (4x/month); (self-reported). - Daily use of nicotine vaping products containing 5% nicotine for at least 3 months prior to enrollment; (self-reported). - Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures. - Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#: NCE-STHC-1), semi-quantitative urinary THCA rapid test (NarcoCheck® THC Pre Dosage), and an illicit drug urine test (NarcoCheck® Évolutive®) during baseline testing, prior to receiving any study-related products. - Negative THC saliva test (NarcoCheck Ref#: NCE-S-THC-1), detection level 1-3 on urinary THCA rapid test (NarcoCheck® THC PreDosage), and illicit drug screen negative for all drugs except THC (NarcoCheck® Évolutive®). - Willing to abstain from nicotine use for 8 hours prior to each study session and abstain from cannabis use 7 days prior to each session. - Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: - Detection level 4-5 (> 300 ng/mL) on urinary THCA rapid test (NarcoCheck® THC PreDosage Ref#: DOA-M03-9B) and a positive result on THC saliva test (NarcoCheck Ref#: NCE-S-THC-1). - Illegal or non-prescription drug use within the past 90 days. As detected by NarcoCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product. THC use detected by NarcoCheck® Évolutive® is permitted - Illegal or non-prescription drug use/alcohol substance use disorder (SUD) within the past year; (self-reported). - Report 2 or more drinking occasions/week with 4 or more drinks/occasion; (self-reported). - Report of daily cigarette use; (self-reported). - Current or prior diagnosis of schizophrenia, bipolar disorder, or other severe psychotic mental illness; (self-reported). - Current or prior diagnosis of myocardial infarction, arrhythmia, or congestive heart failure (self-reported). - Current or prior cancer diagnosis. - Pregnant, currently trying to become pregnant, or breastfeeding (females); (self-reported; pregnancy validated on study visit by urine test). - Regular use of medications that contain nicotine, induce CYP2A6, stimulants, or sympatholytics (e.g., beta-blockers); (self-reported). - Unwilling or unable to follow protocol requirements. - Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation. - The following special populations will be excluded: - Cognitively impaired adults/adults with impaired decision-making capacity - Individuals who are not yet adults (infants, children, teenagers) - Pregnant women - Prisoners - No children or person under the age of 21 will be involved in the study. While those under 21 may use cannabis smoked or vaping products, the legal age of purchasing and using those products in New York State is 21. The current legal age to purchase and use tobacco products in New York State (NYS) is 21. Thus, our provision of study product to adults aged 21 and older is in line with current NYS law.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo blood collection
Drug:
Cannabis sativa Extract
Vape THC
Nicotine
Vape active nicotine
Placebo Administration
Vape placebo nicotine
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum concentration of THC in plasma (Cmax) Pharmacokinetics (PK) profiles of THC in plasma will be determined using a visual plot of plasma THC concentrations by time. Parameters will be derived using non-compartmental analysis in Phoenix WinNonlin and adjusted for baseline THC levels. Will be summarized by nicotine status using the appropriate descriptive statistics and graphical summaries. Up to 21 days
Primary Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360) Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models Up to 21 days
Primary Time to maximum concentration of THC in plasma (Tmax) Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models. Up to 21 days
Secondary Incidence of adverse events (AEs) AEs will be summarized by nicotine condition and grade using frequencies and relative frequencies. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting. Up to 30 days after completion of study intervention
Secondary Puffing behaviors puff duration Up to 21 days
Secondary Puffing behaviors puff number Up to 21 days
Secondary Short-term drug effects The short-term drug effects (Drug Effects Questionnaire [DEQ), The DEQ rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use Up to 21 days
Secondary Marijuana Withdrawal Checklist [MWC) The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal Up to 21 days
Secondary Digit Symbol Substitution Task (DSST) An assessment of cognitive dysfunction that test ability to complete daily tasks Up to 21 days
Secondary Paced Auditory Serial Addition Task (PASET) Measures of working memory and concentration . Up to 21 days
Secondary Tobacco Craving Questionnaire (Short Form) Self reported 47-item questionnaire that assesses tobacco craving. Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Factor scores for each participant are obtained by summing the three items in each factor scale, yielding a score ranging from 3 to 21. Up to 21 days
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 NCT01834794 - Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders N/A
Completed NCT01747850 - Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence Phase 2