09 Sep THC in Pregnancy
The purpose of this study is to better understand how exposure to the hormones estradiol and cortisol influence the body’s processing of tetrahydrocannabinol (THC), the primary psychoactive component of cannabis. THC use is increasingly common among pregnant women, and it is not known how exposure to estradiol and cortisol – hormones that are markedly elevated during pregnancy – may affect the breakdown of THC. This knowledge is critical for understanding how THC use during pregnancy may impact the health of the pregnant woman and her developing baby. The specific question we are exploring is whether exposure to estradiol or cortisol affects the body’s processing of THC in women. Participation in this study involves 9 study visits over ~3 months’ time. Participants will undergo 4 pharmacokinetic tests during the study after a single dose of dronabinol, a prescription drug that contains THC. Dronabinol is not the same as cannabis or THC; rather, it is a manmade form of THC (specifically delta-9 tetrahydrocannabinol). These tests entail taking a single dose of dronabinol (THC) by mouth and undergoing serial collection of blood and urine over the next 24 hours. Test doses of dronabinol will be given before and after 1-week treatment periods with estradiol and hydrocortisone (cortisol). The major risks of taking dronabinol are feeling sick (e.g. dizziness, nausea/vomiting, abdominal pain) and feeling high. Four, ~13-hour visits to the clinical research center will be required, with additional, ~1-hour visits scheduled the following morning. We hope that the knowledge gained from this study will help better determine the safety and risks of THC use during pregnancy.
1. Healthy women
2. 21-45 years old with regular menstrual cycles
3. No known allergies to dronabinol or synthetic glucocorticoids
4. Willing to use nonhormonal methods of birth control to avoid
conception during the study period
Additional Study Details
Full Study Title
Effects of estradiol and cortisol on the pharmacokinetics of tetrahydrocannabinol in women
Accepts Healthy Volunteers?
University Of washington
1959 NE Pacific St
Seattle, Washington 98195