Individual Differences in Drug Response

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• 18-35 years old, females (N=60)

• Body Mass Index 19-26

• High school education, fluent in English

• Occasional cannabis users ( <11 times in past 30 days)

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