Evaluatie van de afgifte en effecten van THC-dampvloeistoffen in de bloedbaan
Acute effecten van sequentieel nicotinevapen op de farmacokinetische en farmacodynamische eigenschappen van verdampte THC: een dubbelblinde, placebogecontroleerde, gerandomiseerde cross-overstudie binnen de proefpersonen
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Vroege fase 1
Contacten en locaties
Studie Locaties
-
-
New York
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Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
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Contact:
- Danielle M. Smith
- Telefoonnummer: 716-845-8403
- E-mail: Danielle.Smith@RoswellPark.org
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Hoofdonderzoeker:
- Danielle M. Smith
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
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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
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Illegal or non-prescription drug use/alcohol substance use disorder (SUD) within the past year; (self-reported).
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Report 2 or more drinking occasions/week with 4 or more drinks/occasion; (self-reported).
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Report of daily cigarette use; (self-reported).
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Current or prior diagnosis of schizophrenia, bipolar disorder, or other severe psychotic mental illness; (self-reported).
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Current or prior diagnosis of myocardial infarction, arrhythmia, or congestive heart failure (self-reported).
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Current or prior cancer diagnosis.
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Pregnant, currently trying to become pregnant, or breastfeeding (females); (self-reported; pregnancy validated on study visit by urine test).
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Regular use of medications that contain nicotine, induce CYP2A6, stimulants, or sympatholytics (e.g., beta-blockers); (self-reported).
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Unwilling or unable to follow protocol requirements.
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Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation.
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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
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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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A (placebo, THC, nicotine)
Participants complete 3 vaping sessions separated by 7-14 days on study:
All participants also undergo blood sample collection throughout the trial. |
Ancillary studies Undergo blood collection
Andere namen:
Vape THC
Andere namen:
Vape active nicotine
Andere namen:
Vape placebo nicotine |
|
Experimenteel: Arm B (placebo, THC, nicotine)
Participants complete 3 vaping sessions separated by 7-14 days on study:
All participants also undergo blood sample collection throughout the trial. |
Ancillary studies Undergo blood collection
Andere namen:
Vape THC
Andere namen:
Vape active nicotine
Andere namen:
Vape placebo nicotine |
|
Experimenteel: Arm C (placebo, THC, nicotine)
Participants complete 3 vaping sessions separated by 7-14 days on study:
All participants also undergo blood sample collection throughout the trial. |
Ancillary studies Undergo blood collection
Andere namen:
Vape THC
Andere namen:
Vape active nicotine
Andere namen:
Vape placebo nicotine |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximum concentration of THC in plasma (Cmax)
Tijdsspanne: Up to 21 days
|
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
|
|
Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)
Tijdsspanne: Up to 21 days
|
Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models |
Up to 21 days
|
|
Time to maximum concentration of THC in plasma (Tmax)
Tijdsspanne: Up to 21 days
|
Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models. |
Up to 21 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of adverse events (AEs)
Tijdsspanne: Up to 30 days after completion of study intervention
|
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
|
|
Puffing behaviors
Tijdsspanne: Up to 21 days
|
puff duration |
Up to 21 days
|
|
Puffing behaviors
Tijdsspanne: Up to 21 days
|
puff number |
Up to 21 days
|
|
Short-term drug effects
Tijdsspanne: Up to 21 days
|
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
|
|
Marijuana Withdrawal Checklist [MWC)
Tijdsspanne: Up to 21 days
|
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
|
|
Digit Symbol Substitution Task (DSST)
Tijdsspanne: Up to 21 days
|
An assessment of cognitive dysfunction that test ability to complete daily tasks |
Up to 21 days
|
|
Paced Auditory Serial Addition Task (PASET)
Tijdsspanne: Up to 21 days
|
Measures of working memory and concentration . |
Up to 21 days
|
|
Tobacco Craving Questionnaire (Short Form)
Tijdsspanne: Up to 21 days
|
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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Danielle M Smith, Roswell Park Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Middelgerelateerde aandoeningen
- Chemisch veroorzaakte aandoeningen
- Marihuana misbruik
- Pyridines
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Onderzoekstechnieken
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Alkaloïden
- Solanaceous alkaloïden
- Nicotine
- Exemplaarbehandeling
- NABIXIMOLS
Andere studie-ID-nummers
- I-3597023
- R01DA057228 (Subsidie/contract van de Amerikaanse NIH)
- I-3597023 (Andere identificatie: Roswell Park Cancer Institute)
- NCI-2024-01556 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
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product vervaardigd in en geëxporteerd uit de V.S.
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