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Még nem keres résztvevőt itt: Egyesült ÁllamokKorai 1. fázis

Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream

A legfontosabb adatok

Ki végzi
Roswell Park Cancer Institute
Hol
Buffalo (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toborzás még nem indult
Fázis
Korai 1. fázis
Résztvevők
60 fő, tervezett
Kezdés
2026. okt. 15.
Várható befejezés
2028. márc. 1.
A vizsgálat típusa
Beavatkozással járó, 3 csoport
A vizsgált kezelések
  • Biospecimen Collection
  • Cannabis sativa Extract
  • Nicotine
  • Placebo Administration
  • Questionnaire Administration
A regiszteradat frissítve
2026. szeptember 25.

Ki vehet részt

Életkor
21 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 24 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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
  • 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)
  • Regular use of medications that contain nicotine, induce CYP2A6, stimulants, or sympatholytics (e.g., beta-blockers); (self-reported)
  • Illegal or non-prescription drug use/alcohol substance use disorder (SUD) within the past year; (self-reported)
  • Current or prior cancer diagnosis
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation
  • 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
  • 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)
  • Report 2 or more drinking occasions/week with 4 or more drinks/occasion; (self-reported)
  • Report of daily cigarette use; (self-reported)
  • Pregnant, currently trying to become pregnant, or breastfeeding (females); (self-reported; pregnancy validated on study visit by urine test)
  • Unwilling or unable to follow protocol requirements
  • 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

Helyszínek itt: Egyesült Államok

  • Roswell Park Cancer InstituteBuffalo, Egyesült ÁllamokContact: Danielle M. SmithToborzás még nem indult

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 3 csoportja

  • Arm A (placebo, THC, nicotine)A vizsgált kezelés

    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. All participants also undergo blood sample collection throughout the trial.

    Kezelés: Biospecimen Collection, Cannabis sativa Extract, Nicotine, Placebo Administration és Questionnaire Administration

  • Arm B (placebo, THC, nicotine)A vizsgált kezelés

    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. All participants also undergo blood sample collection throughout the trial.

    Kezelés: Biospecimen Collection, Cannabis sativa Extract, Nicotine, Placebo Administration és Questionnaire Administration

  • Arm C (placebo, THC, nicotine)A vizsgált kezelés

    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.

    Kezelés: Biospecimen Collection, Cannabis sativa Extract, Nicotine, Placebo Administration és Questionnaire Administration

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Acute Effects of Sequential Nicotine Vaping on the Pharmacokinetic and Pharmacodynamic Properties of Vaped THC: A Double-Blind, Placebo-Controlled, Randomized Within-Subject Crossover Study
A regiszteradat frissítve
2026. szeptember 25.