ToleranceEarly Phase 1ARTNCT04294966
Age-Related Effects of THC
A Early Phase 1 study testing Dextrose and Dronabinol in people with Tolerance and Adolescent Behavior, run by University of Chicago at 2 sites in United States.
Trial summary
Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerance, Adolescent Behavior, THC
- What is being tested?
- Dextrose and Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2020to 1 May 2021
- Phase
- Early 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-20 years old OR 30-40 years old
- Body Mass Index 19-26
- High school education, fluent in English
- Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime)
Who cannot join
- History of daily cannabis use
- Past or present severe substance use disorder
- Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
- Cardiovascular illness, high blood pressure, abnormal electrocardiogram
- Current medications
- Pregnant or planning to become pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Hospital
Chicago, Illinois, 60637
University of Chicago
Chicago, Illinois, 60637
About this study
Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.
Read the detailed description
There is limited knowledge on the effects of THC in adolescents vs adults. One recent report compared responses to vaporized cannabis in heavy adolescent vs adult cannabis users and found that the adolescents were less sensitive to the drug on most measures. However, their findings were complicated by several factors: i) the study used vaporized cannabis, which may have other constituents and does not offer full control of the dose, ii) the participants were heavy users, making it difficult to determine the influence of prior drug exposure, and iii) the participants were not drug-free at the time of testing. Prior exposure to THC can lead to tolerance, and adolescents and adults may differ in the rate at which they develop tolerance, consistent with changes in CB1R receptor function. Our study will compare adolescent (here, aged 18 to 20) and adult (here, aged 30 to 40) responses to THC in relatively light cannabis users who are drug-free at the time of testing.
- Conditions
- Tolerance, Adolescent Behavior, THC
- Being tested
- Dextrose, Dronabinol
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroseDrug
Administering dextrose to healthy volunteers for our placebo group
DronabinolDrug
THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users.
DronabinolDrug
THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Dextrose |
| 7.5 mg THC | Active comparator | Not described Receives: Drug: Dronabinol |
| 15 mg THC | Active comparator | Not described Receives: Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Profile of Mood States (POMS)
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS consists of 72 mood adjectives rated on a Likert scale from 0 (not at all) to 4 (extremely), divided into 8 subscales: Friendliness, Anxiety, Elation, Anger, Fatigue, Depression, Confusion and Vigor, and two composite scales: Positive Mood (Elation minus Depression) and Arousal (Vigor plus Anxiety minus Confusion plus Fatigue). Scoring of this instrument provides a global score of 0 to 120 or individual domain scores of 0 to 20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Measured: Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Mar 2020
- Primary completion1 May 2021
- Study completion1 May 2021
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 ToleranceStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294966
- Sponsor's protocol ID
- IRB20-0112
- Acronym
- ART
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2020
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Effects of THC
- ClinicalTrials.gov ID
- NCT04294966
- Acronym / sponsor ID
- ART / IRB20-0112
- Conditions
- Tolerance, Adolescent Behavior, THC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.
Detailed description
There is limited knowledge on the effects of THC in adolescents vs adults. One recent report compared responses to vaporized cannabis in heavy adolescent vs adult cannabis users and found that the adolescents were less sensitive to the drug on most measures. However, their findings were complicated by several factors: i) the study used vaporized cannabis, which may have other constituents and does not offer full control of the dose, ii) the participants were heavy users, making it difficult to determine the influence of prior drug exposure, and iii) the participants were not drug-free at the time of testing. Prior exposure to THC can lead to tolerance, and adolescents and adults may differ in the rate at which they develop tolerance, consistent with changes in CB1R receptor function. Our study will compare adolescent (here, aged 18 to 20) and adult (here, aged 30 to 40) responses to THC in relatively light cannabis users who are drug-free at the time of testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Dextrose |
| 7.5 mg THC | Active comparator | Drug: Dronabinol |
| 15 mg THC | Active comparator | Drug: Dronabinol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-20 years old OR 30-40 years old
- Body Mass Index 19-26
- High school education, fluent in English
- Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime)
Key exclusion criteria (6 listed)
- History of daily cannabis use
- Past or present severe substance use disorder
- Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
- Cardiovascular illness, high blood pressure, abnormal electrocardiogram
- Current medications
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 |
|---|---|---|
| DextroseAdministering dextrose to healthy volunteers for our placebo group | Drug | Placebo |
| DronabinolTHC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users. | Drug | 7.5 mg THC |
| DronabinolTHC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users. | Drug | 15 mg THC |
Primary outcome
Change From Baseline in Profile of Mood States (POMS)
Time frame: Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS consists of 72 mood adjectives rated on a Likert scale from 0 (not at all) to 4 (extremely), divided into 8 subscales: Friendliness, Anxiety, Elation, Anger, Fatigue, Depression, Confusion and Vigor, and two composite scales: Positive Mood (Elation minus Depression) and Arousal (Vigor plus Anxiety minus Confusion plus Fatigue). Scoring of this instrument provides a global score of 0 to 120 or individual domain scores of 0 to 20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dextrose and Dronabinol in people with Tolerance and Adolescent Behavior, run by University of Chicago at 2 sites 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 4 inclusion and 6 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 9 Nov 2023). 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?
Change From Baseline in Profile of Mood States (POMS) (time frame: Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))). 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 Nov 2023.