Individual Differences in Drug Response

Early Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

History of daily cannabis use
Past or present severe substance use disorder
Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
Past year major depression
Current or past Post Traumatic Stress Disorder
Attention Deficit Hyperactivity Disorder
Cardiovascular illness, high blood pressure, abnormal electrocardiagram
Current medications (NO hormonal birth control or intrauterine device)
Pregnant or planning to become pregnant

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Profile of Mood States (POMS)	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.

Secondary Outcome Measures