Individual Differences in Drug Response (IDT)
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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