An Early Phase 1 interventional study of Biospecimen Collection and Cannabis sativa Extract in Cannabis Dependence, sponsored by Roswell Park Cancer Institute. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Roswell Park Cancer Institute · Early Phase 1, Interventional, and Basic science
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.
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:
ARM B: Participants complete 3 vaping sessions separated by 7-14 days on study:
ARM C: Participants complete 3 vaping sessions separated by 7-14 days on study:
All participants also undergo blood sample collection throughout the trial.
After completion of study intervention, participants are followed up at 30 days.
188 studies on the registry are indexed under Marijuana Abuse; 26 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 160 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Compared within Marijuana Abuse, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The following special populations will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Biospecimen Collection · Drug: Cannabis sativa Extract · Drug: Nicotine · Drug: Placebo Administration · Other: Questionnaire Administration
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.
Procedure: Biospecimen Collection · Drug: Cannabis sativa Extract · Drug: Nicotine · Drug: Placebo Administration · Other: Questionnaire Administration
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.
Procedure: Biospecimen Collection · Drug: Cannabis sativa Extract · Drug: Nicotine · Drug: Placebo Administration · Other: Questionnaire Administration
Undergo blood collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Vape THC
Also known as: Cannabis sativa, Cannabis sativa Flowering Top, Cannabis sativa Subsp. Flowering Top Extract, Cannabis sativa Top
Vape active nicotine
Also known as: (-)-Nicotine, NIC
Vape placebo nicotine
Ancillary studies
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.
Time frame: Up to 21 days
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
Time frame: Up to 21 days
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.
Time frame: Up to 21 days
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.
Time frame: Up to 30 days after completion of study intervention
Puffing behaviors
puff duration
Time frame: Up to 21 days
Puffing behaviors
puff number
Time frame: Up to 21 days
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
Time frame: Up to 21 days
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
Time frame: Up to 21 days
Digit Symbol Substitution Task (DSST)
An assessment of cognitive dysfunction that test ability to complete daily tasks
Time frame: Up to 21 days
Paced Auditory Serial Addition Task (PASET)
Measures of working memory and concentration .
Time frame: Up to 21 days
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.
Time frame: Up to 21 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Nicotine
Roswell Park Cancer Institute →