Cannabis UsePhase 1NCT06609109
Effect of Cannabis on E-Cigarette Use Behavior
A Phase 1 study testing THC High Dose, THC Low Dose and THC 0mg in people with Cannabis Use and Tobacco Use, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Tobacco Use, Electronic Cigarette Use
- What is being tested?
- THC High Dose, THC Low Dose and THC 0mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 1 Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-treatment seeking adults aged 21 or older
- Report daily use of e-cigarettes
- Biological confirmation of e-cigarette use: have a positive urine cotinine test at screening
- Report current use of cannabis (at least 1 occasion per week)
- Have experience with the inhalation route of administration for cannabis
- Biological confirmation of cannabis use: have a positive urinary THC drug test at screening.
- For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study.
Who cannot join
- Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
- Test positive for illicit drugs other than cannabis and tobacco
- Positive breath alcohol test at study admission
- Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
- Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
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- Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
- Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
- Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
Dustin Lee, PhD, 410-550-4035, dlee214@jhmi.edu
Lauren Morris, MHS, 410-550-6953, lmorri20@jhmi.edu
About this study
Official title: Effect of Cannabinoids on Tobacco Product Demand and Pharmacodynamics: Electronic Cigarette Use
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory.
Read the detailed description
A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of electronic cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on e-cigarette use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.
- Conditions
- Cannabis Use, Tobacco Use, Electronic Cigarette Use
- Being tested
- THC High Dose, THC Low Dose, THC 0mg, E-Cigarette Full Nicotine, E-Cigarette Placebo Nicotine
- Keywords
- cannabis, e-cigarette, electronic cigarette, marijuana, THC, Tobacco
- Medical subject headings
- Tobacco Use, Vaping, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC High DoseDrug
Low dose of THC (30 mg)
THC Low DoseDrug
Low dose of THC (5 mg)
THC 0mgDrug
Placebo dose of THC (0 mg)
E-Cigarette Full NicotineDrug
E-Cigarette with Nicotine
E-Cigarette Placebo NicotineDrug
E-Cigarette with No Nicotine
| Study group | Role | What they receive |
|---|---|---|
| Smoked THC | Experimental | Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Receives: Drug: THC High Dose; Drug: THC Low Dose; Drug: THC 0mg; Drug: E-Cigarette Full Nicotine; Drug: E-Cigarette Placebo Nicotine |
| Vaporized THC | Experimental | Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. Receives: Drug: THC High Dose; Drug: THC Low Dose; Drug: THC 0mg; Drug: E-Cigarette Full Nicotine; Drug: E-Cigarette Placebo Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand Intensity
Consumption of e-cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).
Measured: 45 minutes after THC or placebo administration
Demand Elasticity
Changes in e-cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).
Measured: 45 minutes after THC or placebo administration
Secondary outcomes (8)
Minnesota Nicotine Withdrawal Scale (MNWS)
A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1
Self report assessment smoking urges. Factor 1 - Intention/Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2
Self report assessment smoking urges. Factor 2 - Relief of Negative Affect \& Urgent Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Drug Effect Questionnaire for Like Drug
The Drug Effect Questionnaire will be administered using a visual analog scale. Participants place a mark on a 100mm line with the left endpoint labeled Not at All and the right endpoint labeled Extremely. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Heart Rate
Heart rate will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Diastolic Blood Pressure
Diastolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Systolic Blood Pressure
Systolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Divided Attention Task (DAT) Performance
Participants will complete a Divided Attention Task (DAT) in which the participants must simultaneously track a stimulus moving horizontally on a computer screen and respond to visual stimuli presented. The primary dependent measure is the average distance maintained from the target stimulus. Primary outcomes will be the peak change from baseline.
Measured: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start19 Mar 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dustin Lee, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609109
- Sponsor's protocol ID
- IRB00435112
- Other IDs
- R01DA058624
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabinoids on Tobacco Product Demand and Pharmacodynamics: Electronic Cigarette Use
- ClinicalTrials.gov ID
- NCT06609109
- Acronym / sponsor ID
- IRB00435112
- Conditions
- Cannabis Use, Tobacco Use, Electronic Cigarette Use
- Keywords
- cannabis, e-cigarette, electronic cigarette, marijuana, THC, Tobacco
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory.
Detailed description
A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of electronic cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on e-cigarette use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoked THC | Experimental | Drug: THC High Dose, Drug: THC Low Dose, Drug: THC 0mg, Drug: E-Cigarette Full Nicotine, Drug: E-Cigarette Placebo NicotineEach participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. |
| Vaporized THC | Experimental | Drug: THC High Dose, Drug: THC Low Dose, Drug: THC 0mg, Drug: E-Cigarette Full Nicotine, Drug: E-Cigarette Placebo NicotineEach participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive e-cigarette containing 0% and 5.0% nicotine. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy non-treatment seeking adults aged 21 or older
- Report daily use of e-cigarettes
- Biological confirmation of e-cigarette use: have a positive urine cotinine test at screening
- Report current use of cannabis (at least 1 occasion per week)
- Have experience with the inhalation route of administration for cannabis
Key exclusion criteria (9 listed)
- Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
- Test positive for illicit drugs other than cannabis and tobacco
- Positive breath alcohol test at study admission
- Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC High DoseLow dose of THC (30 mg) | Drug | Smoked THC, Vaporized THC |
| THC Low DoseLow dose of THC (5 mg) | Drug | Smoked THC, Vaporized THC |
| THC 0mgPlacebo dose of THC (0 mg) | Drug | Smoked THC, Vaporized THC |
| E-Cigarette Full NicotineE-Cigarette with Nicotine | Drug | Smoked THC, Vaporized THC |
| E-Cigarette Placebo NicotineE-Cigarette with No Nicotine | Drug | Smoked THC, Vaporized THC |
Primary outcome
Demand Intensity
Time frame: 45 minutes after THC or placebo administration
Consumption of e-cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).
Demand Elasticity
Time frame: 45 minutes after THC or placebo administration
Changes in e-cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).
8 secondary outcomes
Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Drug Effect Questionnaire for Like Drug
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Heart Rate
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Diastolic Blood Pressure
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Systolic Blood Pressure
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Divided Attention Task (DAT) Performance
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dustin Lee, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THC High Dose, THC Low Dose and THC 0mg in people with Cannabis Use and Tobacco Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Brogdon, MHS (410-550-6953, lmorri20@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand Intensity (time frame: 45 minutes after THC or placebo administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.