CannabisPhase 1NCT04124432
Behavioral Pharmacology of Cannabis and Nicotine
A Phase 1 study testing Cannabis and Nicotine in people with Cannabis and Nicotine, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Cannabis and Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have provided written informed consent
- Be between the ages of 18 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Test negative for drugs of abuse aside from cannabis (via urine sample) and alcohol (via breath sample) at the screening visit and upon arrival for each experimental session.
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
- Have a body mass index (BMI) in the range of 18 to 36 kg/m2
Show all 13Show fewer
- Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- Have not donated blood in the prior 30 days.
- Report prior experience inhaling cannabis.
- Report using cannabis at least 5 times in the past year.
- Smoke ≥5 tobacco cigarettes per day on average in the past month.
- Use an e-cigarette at least 15 of the past 30 days.
- Have a breath carbon monoxide (CO) of >8ppm or urine cotinine >200ng/mL to confirm current nicotine use status.
Who cannot join
- Non-medical use of psychoactive drugs (aside from cannabis) other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
- History of or current evidence of significant medical or psychiatric illness which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
Show all 11Show fewer
- Epilepsy or a history of seizures.
- Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician
- Individuals with anemia.
- Prior history of allergic or serious adverse reaction to either cannabis or tobacco/nicotine.
- Average use of cannabis more than 2 times per week in the prior 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine.
Read the detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). All participants will be healthy adult volunteers who are regular nicotine/tobacco users, and have prior experience with cannabis use. Participants will complete seven outpatient experimental test sessions (completed in a randomized order), under double-blind conditions in which participants will first self-administer smoked cannabis (either active or placebo), followed by nicotine (via a tobacco cigarette or an e-cigarette); there will also be one condition in which participants smoke active cannabis alone (without subsequent nicotine use). Nicotine self-administration will occur in an ad libitum fashion for 5 hours. Nicotine products will be the individual participant's preferred brand of cigarettes or the commercial pod-style e-cigarette the JUUL (pods will contain either 3% or 5% nicotine pods). Active cannabis will contain 10 mg tetrahydrocannabinol (THC) while placebo will contain 0 mg THC. During the ad libitum nicotine/tobacco-use period, various puffing behaviors (e.g., puff volume, puff duration, puff number, inter-puff-interval) will be measured using specialized equipment. Acute subjective effects of cannabis/nicotine, cannabis/nicotine withdrawal symptoms, craving, vital signs, and cognitive/psychomotor performance will also be assessed throughout the experimental sessions.
- Being tested
- Cannabis, Nicotine
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Cannabis will be smoked
NicotineDrug
Nicotine will be smoked or vaporized
| Study group | Role | What they receive |
|---|---|---|
| Active cannabis without nicotine | Experimental | Smoked cannabis containing 10mg THC + No nicotine/tobacco Receives: Drug: Cannabis |
| Active cannabis with own brand cigarettes | Experimental | Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes Receives: Drug: Cannabis; Drug: Nicotine |
| Active cannabis with low nicotine e-cigarette | Experimental | Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Receives: Drug: Cannabis; Drug: Nicotine |
| Active cannabis with high nicotine e-cigarette | Experimental | Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Receives: Drug: Cannabis; Drug: Nicotine |
| placebo cannabis with own brand cigarettes | Experimental | Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes Receives: Drug: Cannabis; Drug: Nicotine |
| Placebo cannabis with low nicotine e-cigarette | Experimental | Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Receives: Drug: Cannabis; Drug: Nicotine |
| Placebo cannabis with high nicotine e-cigarette | Experimental | Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Receives: Drug: Cannabis; Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Nicotine (mL of Smoke/Vapor) Inhaled
Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session.
Measured: 0-5 hours
Secondary outcomes (6)
Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
Mean Peak Change From Baseline rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.
Measured: 0-5 hours
Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Measured: 0-5 hours
Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
Measured: 0-5 hours
Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App
Behavioral task performance will be assessed with the DRUID app's Global impairment score (range 0-100), where lower scores indicate better performance.
Measured: 0-5 hours
Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire
Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving.
Measured: 0-5 hours
Mean Peak Change From Baseline Cannabis Craving as Assessed by the Cannabis Craving Questionnaire
Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving
Measured: 0-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start15 Sep 2020
- Primary completion24 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CannabisStudies 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
- Crossover
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
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
- Ryan Vandrey, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124432
- Sponsor's protocol ID
- IRB00220975
- Other IDs
- R21DA044377
- Status last verified
- Mar 2024
- First submitted
- 10 Oct 2019
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Pharmacology of Cannabis and Nicotine
- ClinicalTrials.gov ID
- NCT04124432
- Acronym / sponsor ID
- IRB00220975
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine.
Detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). All participants will be healthy adult volunteers who are regular nicotine/tobacco users, and have prior experience with cannabis use. Participants will complete seven outpatient experimental test sessions (completed in a randomized order), under double-blind conditions in which participants will first self-administer smoked cannabis (either active or placebo), followed by nicotine (via a tobacco cigarette or an e-cigarette); there will also be one condition in which participants smoke active cannabis alone (without subsequent nicotine use). Nicotine self-administration will occur in an ad libitum fashion for 5 hours. Nicotine products will be the individual participant's preferred brand of cigarettes or the commercial pod-style e-cigarette the JUUL (pods will contain either 3% or 5% nicotine pods). Active cannabis will contain 10 mg tetrahydrocannabinol (THC) while placebo will contain 0 mg THC. During the ad libitum nicotine/tobacco-use period, various puffing behaviors (e.g., puff volume, puff duration, puff number, inter-puff-interval) will be measured using specialized equipment. Acute subjective effects of cannabis/nicotine, cannabis/nicotine withdrawal symptoms, craving, vital signs, and cognitive/psychomotor performance will also be assessed throughout the experimental sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Active cannabis without nicotine | Experimental | Drug: CannabisSmoked cannabis containing 10mg THC + No nicotine/tobacco |
| Active cannabis with own brand cigarettes | Experimental | Drug: Cannabis, Drug: NicotineSmoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes |
| Active cannabis with low nicotine e-cigarette | Experimental | Drug: Cannabis, Drug: NicotineSmoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) |
| Active cannabis with high nicotine e-cigarette | Experimental | Drug: Cannabis, Drug: NicotineSmoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) |
| placebo cannabis with own brand cigarettes | Experimental | Drug: Cannabis, Drug: NicotineSmoked placebo cannabis + ad-libitum use of preferred brand cigarettes |
| Placebo cannabis with low nicotine e-cigarette | Experimental | Drug: Cannabis, Drug: NicotineSmoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) |
| Placebo cannabis with high nicotine e-cigarette | Experimental | Drug: Cannabis, Drug: NicotineSmoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Have provided written informed consent
- Be between the ages of 18 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Test negative for drugs of abuse aside from cannabis (via urine sample) and alcohol (via breath sample) at the screening visit and upon arrival for each experimental session.
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Key exclusion criteria (11 listed)
- Non-medical use of psychoactive drugs (aside from cannabis) other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
- History of or current evidence of significant medical or psychiatric illness which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
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 |
|---|---|---|
| CannabisCannabis will be smoked | Drug | Active cannabis with high nicotine e-cigarette, Active cannabis with low nicotine e-cigarette, Active cannabis with own brand cigarettes, Active cannabis without nicotine, Placebo cannabis with high nicotine e-cigarette, Placebo cannabis with low nicotine e-cigarette, placebo cannabis with own brand cigarettes |
| NicotineNicotine will be smoked or vaporized | Drug | Active cannabis with high nicotine e-cigarette, Active cannabis with low nicotine e-cigarette, Active cannabis with own brand cigarettes, Placebo cannabis with high nicotine e-cigarette, Placebo cannabis with low nicotine e-cigarette, placebo cannabis with own brand cigarettes |
Primary outcome
Amount of Nicotine (mL of Smoke/Vapor) Inhaled
Time frame: 0-5 hours
Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session.
6 secondary outcomes
Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 0-5 hours
Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)
Time frame: 0-5 hours
Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)
Time frame: 0-5 hours
Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App
Time frame: 0-5 hours
Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire
Time frame: 0-5 hours
Mean Peak Change From Baseline Cannabis Craving as Assessed by the Cannabis Craving Questionnaire
Time frame: 0-5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cannabis
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
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. This study is not recruiting at the moment.
Ryan Vandrey principal investigator
Johns Hopkins University
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 Cannabis and Nicotine in people with Cannabis and Nicotine, 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 13 inclusion and 11 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: finished, as of the sponsor's last update on 17 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Nicotine (mL of Smoke/Vapor) Inhaled (time frame: 0-5 hours). 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 17 Apr 2024.