VapingPhase 3NCT04340700
Characterization of the Pharmacodynamic Response to Vaped THC
A Phase 3 study of Vaping and THC, run by Massachusetts General Hospital.
Trial summary
This study aims to characterize the pharmacodynamic response to vaped THC in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with THC vs placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 18-55 years, inclusive.
- Competent and willing to provide written informed consent.
- Able to communicate in English language.
- Regular, at least weekly on average, marijuana use
- Self-reported ability to abstain from cannabis for 24 hours without withdrawal.
Who cannot join
- Any unstable, serious medical illness or cardiovascular disease/events.
- New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder.
- Diabetes, cirrhosis, renal failure, Hepatitis C, or HIV.
- History of syncope without an identified situational stressor, migraines >1x/month, or head injury with prolonged unconsciousness (> 24 hours).
- Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents.
- Current pregnancy, lactation or trying to become pregnant (confirmed by urine pregnancy test).
Show all 10Show fewer
- History of substance abuse treatment and intent to quit or receiving treatment for cannabis use.
- Affective disorder in the past month or history of panic attacks.
- Smoking more than 10 tobacco cigarettes or equivalent e-cigarettes a day.
- In the opinion of the investigator, not able to safely participate in this study.
About this study
This study aims to characterize the pharmacodynamic response to vaped THC in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with THC vs placebo.
Read the detailed description
Enrollees will include 120 healthy, weekly or greater MJ users, aged 18-55. The study will be conducted according to a double-blind, placebo-controlled, random order, cross-over design, consisting of one 3-hour screening visit and 2 randomized, approximately 6-hour laboratory sessions. At the latter visits (following confirmation of eligibility), subjects will complete baseline questionnaires and assessments, including a driver simulator test, a blood draw, vitals, and an imaging session using functional near-infrared spectroscopy (fNIRS). Subjects will then vape a first dose (either THC or placebo based on randomization). Vitals and questionnaires will then be administered throughout the visit, at baseline, and at approximately 15, 60, 90, 130, 165, and 210 minutes post initial dose. Subjects will also perform fNIRS testing at baseline, 30, and 180 minutes and driver simulator at baseline, 60, and 90 minutes post initial THC/placebo administration. A drug recognition expert (DRE) will conduct a standard field sobriety test to identify impairment at approximately 130 minutes post dose. Following the initial dose vaped at 0 minutes, standardized reduced doses will be vaped approximately 30, 60, and 90 minutes later. Given the cross-over design of this study, participants will be assigned to receive THC or placebo at the first laboratory visit and will receive the other substance at the second laboratory visit.
- Being tested
- THC or Placebo
- Keywords
- Vaping, THC, fNIRS, Cannabis, Imaging
- Medical subject headings
- Vaping, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC or PlaceboDrug
A standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures.
| Study group | Role | What they receive |
|---|---|---|
| THC | Experimental | A standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. Receives: Drug: THC or Placebo |
| Placebo | Placebo comparator | Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures. Receives: Drug: THC or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drug Effects Questionnaire
This 15-item questionnaire measures drug effects, behavioral/mood states, and craving. Each item is scored from 0-100, and all items are averaged for a total score from 0-100 with higher scores indicating greater drug effect.
Measured: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
Change in Biphasic Alcohol Effects Scale (Modified for THC)
This 14-item questionnaire measures stimulation and sedation. The Stimulation subscale scores range from 7-70 with higher scores indicating greater stimulation. The Sedation subscale scores range from 7-70 with higher scores indicating greater sedation.
Measured: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
Change in The Spielberger State Anxiety Inventory
This 20-item questionnaire measures state/current anxiety. Scores range from 20-80 with higher scores indicating greater state anxiety.
Measured: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
Change in Driving Simulation Performance on the Divided Attention Task (DAT)
A computer-programmed driving simulator will assess DAT performance using percentage impaired (from 0-100%).
Measured: Pre-dose, and 60 and 90 minutes post dose
Secondary outcomes (1)
Change in Functional Near-Infrared Spectroscopy (fNIRS) Brain Signal
fNIRS measures oxygenated hemoglobin (HbO) during both resting state and a working memory task in both THC and placebo conditions.
Measured: Pre-dose, and 30 and 180 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Nov 2022 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: Funding not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
- Investigators
- Eden Evins, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340700
- Sponsor's protocol ID
- 2020P000055
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2020
- Last updated
- 11 Feb 2022
- Results posted
- No
- 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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Pharmacodynamic Response to Vaped THC
- ClinicalTrials.gov ID
- NCT04340700
- Acronym / sponsor ID
- 2020P000055
- Keywords
- Vaping, THC, fNIRS, Cannabis, Imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Apr 2020 (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.
This study aims to characterize the pharmacodynamic response to vaped THC in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with THC vs placebo.
Detailed description
Enrollees will include 120 healthy, weekly or greater MJ users, aged 18-55. The study will be conducted according to a double-blind, placebo-controlled, random order, cross-over design, consisting of one 3-hour screening visit and 2 randomized, approximately 6-hour laboratory sessions. At the latter visits (following confirmation of eligibility), subjects will complete baseline questionnaires and assessments, including a driver simulator test, a blood draw, vitals, and an imaging session using functional near-infrared spectroscopy (fNIRS). Subjects will then vape a first dose (either THC or placebo based on randomization). Vitals and questionnaires will then be administered throughout the visit, at baseline, and at approximately 15, 60, 90, 130, 165, and 210 minutes post initial dose. Subjects will also perform fNIRS testing at baseline, 30, and 180 minutes and driver simulator at baseline, 60, and 90 minutes post initial THC/placebo administration. A drug recognition expert (DRE) will conduct a standard field sobriety test to identify impairment at approximately 130 minutes post dose. Following the initial dose vaped at 0 minutes, standardized reduced doses will be vaped approximately 30, 60, and 90 minutes later. Given the cross-over design of this study, participants will be assigned to receive THC or placebo at the first laboratory visit and will receive the other substance at the second laboratory visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THC | Experimental | Drug: THC or PlaceboA standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. |
| Placebo | Placebo comparator | Drug: THC or PlaceboPlacebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged 18-55 years, inclusive.
- Competent and willing to provide written informed consent.
- Able to communicate in English language.
- Regular, at least weekly on average, marijuana use
- Self-reported ability to abstain from cannabis for 24 hours without withdrawal.
Key exclusion criteria (10 listed)
- Any unstable, serious medical illness or cardiovascular disease/events.
- New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder.
- Diabetes, cirrhosis, renal failure, Hepatitis C, or HIV.
- History of syncope without an identified situational stressor, migraines >1x/month, or head injury with prolonged unconsciousness (> 24 hours).
- Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents.
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 or PlaceboA standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures. | Drug | Placebo, THC |
Primary outcome
Change in Drug Effects Questionnaire
Time frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
This 15-item questionnaire measures drug effects, behavioral/mood states, and craving. Each item is scored from 0-100, and all items are averaged for a total score from 0-100 with higher scores indicating greater drug effect.
Change in Biphasic Alcohol Effects Scale (Modified for THC)
Time frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
This 14-item questionnaire measures stimulation and sedation. The Stimulation subscale scores range from 7-70 with higher scores indicating greater stimulation. The Sedation subscale scores range from 7-70 with higher scores indicating greater sedation.
Change in The Spielberger State Anxiety Inventory
Time frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose
This 20-item questionnaire measures state/current anxiety. Scores range from 20-80 with higher scores indicating greater state anxiety.
Change in Driving Simulation Performance on the Divided Attention Task (DAT)
Time frame: Pre-dose, and 60 and 90 minutes post dose
A computer-programmed driving simulator will assess DAT performance using percentage impaired (from 0-100%).
1 secondary outcome
Change in Functional Near-Infrared Spectroscopy (fNIRS) Brain Signal
Time frame: Pre-dose, and 30 and 180 minutes post dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Vaping
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Active, not recruiting
Mindful Breaths: Mindfulness for Young Adult Vaping
Vaping Cessation
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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.
Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Vaping and THC, run by Massachusetts General Hospital.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Drug Effects Questionnaire (time frame: Pre-dose, and 15, 60, 90, 130, 165, 210 minutes post dose). The study lists 4 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 11 Feb 2022.