An Early Phase 1 interventional study of Dextrose and Dronabinol in Tolerance, Adolescent Behavior and THC, sponsored by University of Chicago. Completed at 2 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by University of Chicago · Early Phase 1, Interventional, and Basic science
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.
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.
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Drug: Dextrose
Drug: Dronabinol
Drug: Dronabinol
Administering dextrose to healthy volunteers for our placebo group
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.
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.
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.
Time frame: Through Study Completion, an average of 3 weeks (Baseline - time 0 to Time point 9 (Study Completion))
| Milestone | Placebo | 7.5 mg THC | 15 mg THC |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Placebo | 7.5 mg THC | 15 mg THC |
|---|---|---|---|
| POMS Anxiety Week 1 | 5.75 ± 5.12 | 12.46 ± 3.56 | 18.55 ± 2.55 |
| POMS Depression Week 1 | 4.08 ± 3.60 | 5.05 ± 3.66 | 6.25 ± 1.05 |
| POMS Vigor Week 1 | 13.00 ± 6.03 | 8.05 ± 2.25 | 8.25 ± 4.25 |
| POMS Fatigue Week 1 | 6.67 ± 6.27 | 14.25 ± 6.85 | 8.25 ± 2.55 |
| POMS Friendliness Week 1 | 6.42 ± 3.82 | 16.25 ± 5.58 | 8.25 ± 2.22 |
| POMS Anxiety Week 3 | 5.50 ± 4.56 | 14.25 ± 5.88 | 19.25 ± 5.22 |
| POMS Depression Week 3 | 3.92 ± 6.64 | 5.28 ± 1.33 | 8.25 ± 2.55 |
| POMS Vigor Week 3 | 16.83 ± 5.92 | 6.87 ± 4.25 | 6.22 ± 2.22 |
| POMS Fatigue Week 3 | 6.0 ± 4.86 | 8.65 ± 2.58 | 6.25 ± 2.55 |
| POMS Friendliness Week 3 | 9.42 ± 5.99 | 8.22 ± 2.25 | 11.25 ± 2.25 |
Collected over .Through study completion, an average of 3 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 7.5 mg THC | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 15 mg THC | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Placebo | 7.5 mg THC | 15 mg THC | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 8 | 24 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | 7.5 mg THC | 15 mg THC | Total |
|---|---|---|---|---|
| Female | 4 | 4 | 4 | 12 |
| Male | 4 | 4 | 4 | 12 |
| Race (NIH/OMB)(Participants) | Placebo | 7.5 mg THC | 15 mg THC | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 1 | 6 |
| White | 4 | 4 | 4 | 12 |
| More than one race | 0 | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | 7.5 mg THC | 15 mg THC | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 8 | 24 |
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