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Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-07-03
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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 (Ménétrey et al., 2005; Issa et al. 2016).
We are administering dextrose to health volunteers for our placebo group
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 20 | 2.58 | 0.047 |
| 7.5 mg THC | 20 | 4.28 | 0.07 |
| 15 mg THC | 20 | 8.25 | 0.05 |
| Placebo | 20 | 0.7 | 0.005 |
| 7.5 mg THC | 20 | 1.2 | 0.02 |
| 15 mg THC | 20 | 1.04 | 0.004 |
| Placebo | 20 | 1.2 | .01 |
| 7.5 mg THC | 20 | 1.5 | .025 |
| 15 mg THC | 20 | 4.25 | .036 |
| Placebo | 20 | 5.02 | 0.04 |
| 7.5 mg THC | 20 | 7.5 | 0.05 |
| 15 mg THC | 20 | 6.25 | 0.09 |
| Placebo | 20 | 2.0 | 0.11 |
| 7.5 mg THC | 20 | 3.75 | 0.04 |
| 15 mg THC | 20 | 7.25 | 0.01 |
| Placebo | 20 | 2.0 | 0.065 |
| 7.5 mg THC | 20 | 2.25 | 0.055 |
| 15 mg THC | 20 | 3.25 | 0.04 |
| Milestone | Placebo | 7.5 mg THC | 15 mg THC |
|---|---|---|---|
| STARTED | 20 | 20 | 20 |
| COMPLETED | 20 | 20 | 20 |
| NOT COMPLETED | 0 | 0 | 0 |
Eligibility
primary outcomes
Time frame: Difference from baseline (time 0 or pre-capsule) to post-capsule (120 min)
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Publications
No exact PMID-linked public article is currently readable locally.