Trial Outcomes & Findings for Effects of Pregnancy-associated Hormones on THC Metabolism in Women (NCT NCT04374773)
NCT ID: NCT04374773
Last Updated: 2026-05-06
Results Overview
Area under plasma concentration-time curve (AUC) for THC. For AUC calculation the time points of 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hrs post dosing were included
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
24 hours
Results posted on
2026-05-06
Participant Flow
Participant milestones
| Measure |
Estradiol to Cortisol Crossover
Period 1: Estradiol 1 week treatment with 0.3 mg/24 hr transdermal estradiol Dronabinol: 2.5 mg PO administered once prior to and once after 1 week of hormone therapy
Period 2: Cortisol
1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses Dronabinol: 2.5 mg PO administered once prior to and once after 1 week of hormone therapy
|
Cortisol to Estradiol Crossover
Period 1: Cortisol 1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses Dronabinol: 2.5 mg PO administered once prior to and once after 1 week of hormone therapy Period 2: Estradiol
1 week treatment with 0.3 mg/24 hr transdermal estradiol Dronabinol: 2.5 mg PO administered once prior to and once after 1 week of hormone therapy
|
|---|---|---|
|
First treatment
STARTED
|
8
|
6
|
|
First treatment
COMPLETED
|
7
|
6
|
|
First treatment
NOT COMPLETED
|
1
|
0
|
|
Crossover
STARTED
|
7
|
5
|
|
Crossover
COMPLETED
|
7
|
5
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Pregnancy-associated Hormones on THC Metabolism in Women
Baseline characteristics by cohort
| Measure |
Estradiol to Cortisol Crossover
n=8 Participants
Participants first got 1 week treatment with 0.3 mg/24 hr transdermal estradiol Dronabinol was given at 2.5 mg PO once prior to and once after 1 week of hormone therapy.
After crossover the participants got 1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses Dronabinol was given at 2.5 mg PO once prior to and once after 1 week of hormone therapy
|
Cortisol to Estradiol Crossover
n=6 Participants
Participants first got 1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses Dronabinol was given at 2.5 mg PO once prior to and once after 1 week of hormone therapy.
After crossover the participants got 1 week treatment with 0.3 mg/24 hr transdermal estradiol Dronabinol was given at 2.5 mg PO once prior to and once after 1 week of hormone therapy
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=54 Participants
|
26.3 years
n=60 Participants
|
27.2 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=54 Participants
|
6 participants
n=60 Participants
|
14 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 24 hoursArea under plasma concentration-time curve (AUC) for THC. For AUC calculation the time points of 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hrs post dosing were included
Outcome measures
| Measure |
Estradiol Control
n=12 Participants
The control day for estradiol arm
|
Estradiol Treatment
n=12 Participants
Data from estradiol treatment arm
|
Cortisol Control
n=13 Participants
The control day of cortisol arm
|
Cortisol Treatment
n=13 Participants
Data from cortisol treatment arm
|
|---|---|---|---|---|
|
Dronabinol Exposure
|
7.0 nM*h
Interval 4.6 to 11.0
|
5.6 nM*h
Interval 3.8 to 8.2
|
5.1 nM*h
Interval 3.6 to 7.2
|
5.0 nM*h
Interval 3.6 to 7.0
|
SECONDARY outcome
Timeframe: 24 hoursArea under plasma concentration-time curve (AUC) for 11-OH-THC. For AUC calculation the time points of 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hrs post dosing were included
Outcome measures
| Measure |
Estradiol Control
n=12 Participants
The control day for estradiol arm
|
Estradiol Treatment
n=12 Participants
Data from estradiol treatment arm
|
Cortisol Control
n=13 Participants
The control day of cortisol arm
|
Cortisol Treatment
n=13 Participants
Data from cortisol treatment arm
|
|---|---|---|---|---|
|
THC Primary Metabolite Exposure
|
13 nM*h
Interval 10.0 to 16.0
|
11 nM*h
Interval 8.9 to 14.0
|
11 nM*h
Interval 9.5 to 13.0
|
13 nM*h
Interval 10.0 to 18.0
|
SECONDARY outcome
Timeframe: 24 hoursArea under plasma concentration-time curve (AUC) for 11-nor-COOH-THC. For AUC calculation the time points of 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hrs post dosing were included
Outcome measures
| Measure |
Estradiol Control
n=12 Participants
The control day for estradiol arm
|
Estradiol Treatment
n=12 Participants
Data from estradiol treatment arm
|
Cortisol Control
n=13 Participants
The control day of cortisol arm
|
Cortisol Treatment
n=13 Participants
Data from cortisol treatment arm
|
|---|---|---|---|---|
|
THC Secondary Metabolite Exposure
|
258 nM*h
Interval 176.0 to 380.0
|
180 nM*h
Interval 102.0 to 317.0
|
228 nM*h
Interval 160.0 to 327.0
|
226 nM*h
Interval 156.0 to 328.0
|
SECONDARY outcome
Timeframe: 12 hoursVisual analog scale ratings of subjective 'high'. The participants self rated how they feel based on the statement from 1-6, where 6 indicates "extremely" or "least false" and 1 is "not at all".
Outcome measures
| Measure |
Estradiol Control
n=12 Participants
The control day for estradiol arm
|
Estradiol Treatment
n=12 Participants
Data from estradiol treatment arm
|
Cortisol Control
n=13 Participants
The control day of cortisol arm
|
Cortisol Treatment
n=13 Participants
Data from cortisol treatment arm
|
|---|---|---|---|---|
|
Pharmacologic Effects of THC
|
1.4 score on a scale
Interval 1.1 to 1.8
|
1.6 score on a scale
Interval 1.2 to 2.0
|
1.4 score on a scale
Interval 1.1 to 1.8
|
1.5 score on a scale
Interval 1.2 to 2.0
|
Adverse Events
Estradiol Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cortisol Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Estradiol Treatment
n=12 participants at risk
Adverse events related to estradiol treatment
|
Cortisol Treatment
n=13 participants at risk
Adverse events related to cortisol treatment
|
|---|---|---|
|
Infections and infestations
Yeast infection
|
8.3%
1/12 • Number of events 1 • 1 week (For duration of the study)
Adverse events were recorded throughout the study via queries on study days and through requested phone calls with study physicians.
|
0.00%
0/13 • 1 week (For duration of the study)
Adverse events were recorded throughout the study via queries on study days and through requested phone calls with study physicians.
|
|
General disorders
Insomnia
|
0.00%
0/12 • 1 week (For duration of the study)
Adverse events were recorded throughout the study via queries on study days and through requested phone calls with study physicians.
|
15.4%
2/13 • Number of events 2 • 1 week (For duration of the study)
Adverse events were recorded throughout the study via queries on study days and through requested phone calls with study physicians.
|
|
General disorders
Skin inflammation
|
0.00%
0/12 • 1 week (For duration of the study)
Adverse events were recorded throughout the study via queries on study days and through requested phone calls with study physicians.
|
7.7%
1/13 • Number of events 1 • 1 week (For duration of the study)
Adverse events were recorded throughout the study via queries on study days and through requested phone calls with study physicians.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place