Trial Outcomes & Findings for Impact of Progesterone on Stress Reactivity and Cannabis Use (NCT NCT03729869)

NCT ID: NCT03729869

Last Updated: 2023-09-28

Results Overview

Subjects will rate marijuana craving on a 0-7 Likert scale where 0 is Not at All and 7 is extremely.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

Immediately post stress/cue task.

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Progesterone Males 39 men will take 400 mg of progesterone a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Males 41 men will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.	Progesterone Female 35 women will take 200 mg of progesterone twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Females 31 women will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.
Overall Study STARTED	40	42	35	31
Overall Study COMPLETED	39	41	35	31
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Progesterone on Stress Reactivity and Cannabis Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Progesterone Males n=39 Participants 39 men will take 400 mg of progesterone a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Males n=41 Participants 41 men will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.	Progesterone Female n=35 Participants 34 women will take 200 mg of progesterone twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Females n=31 Participants 31 women will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=93 Participants	41 Participants n=4 Participants	35 Participants n=27 Participants	31 Participants n=483 Participants	146 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	35 Participants n=27 Participants	31 Participants n=483 Participants	66 Participants n=36 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	41 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	80 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants	8 Participants n=483 Participants	29 Participants n=36 Participants
Race (NIH/OMB) White	32 Participants n=93 Participants	35 Participants n=4 Participants	24 Participants n=27 Participants	23 Participants n=483 Participants	114 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	39 participants n=93 Participants	41 participants n=4 Participants	35 participants n=27 Participants	31 participants n=483 Participants	146 participants n=36 Participants

PRIMARY outcome

Timeframe: Immediately post stress/cue task.

Population: Males and females randomly assigned to take progesterone or placebo.

Subjects will rate marijuana craving on a 0-7 Likert scale where 0 is Not at All and 7 is extremely.

Outcome measures

Outcome measures
Measure	Progesterone Males n=39 Participants 39 men will take 400 mg of progesterone a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Males n=41 Participants 41 men will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.	Progesterone Female n=35 Participants 35 women will take 200 mg of progesterone twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Females n=31 Participants 31 women will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.
Cannabis Craving	3.7 units on a scale Standard Deviation 2.3	3.4 units on a scale Standard Deviation 2.2	4.3 units on a scale Standard Deviation 2.6	4.5 units on a scale Standard Deviation 2.1

Adverse Events

Progesterone Males

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo Males

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Progesterone Female

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo Females

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Lisa Nunn, Program Manager

Medical University of South Carolina

Phone: 843-792-0476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Progesterone Males n=39 participants at risk 39 men will take 400 mg of progesterone a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Males n=41 participants at risk 41 men will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.	Progesterone Female n=35 participants at risk 34 women will take 200 mg of progesterone twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Progesterone: 200 mg of exogenous progesterone twice a day	Placebo Females n=31 participants at risk 31 women will take placebo twice a day for 7 days and will complete a stress and marijuana cue reactivity task following the final dose. Placebo: One dose of matched placebo twice a day.
Nervous system disorders Headache	23.1% 9/39 • Number of events 9 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	17.1% 7/41 • Number of events 7 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	25.7% 9/35 • Number of events 9 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	35.5% 11/31 • Number of events 11 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
General disorders Marijuana withdrawal syndrome	7.7% 3/39 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	19.5% 8/41 • Number of events 8 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.9% 1/35 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	6.5% 2/31 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Irritability	15.4% 6/39 • Number of events 6 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	9.8% 4/41 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	20.0% 7/35 • Number of events 7 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	12.9% 4/31 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Gastrointestinal disorders Decreased appetite	20.5% 8/39 • Number of events 8 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	9.8% 4/41 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	17.1% 6/35 • Number of events 6 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	16.1% 5/31 • Number of events 5 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Gastrointestinal disorders Nausea	15.4% 6/39 • Number of events 6 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	9.8% 4/41 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	25.7% 9/35 • Number of events 10 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	12.9% 4/31 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Vascular disorders Hot Flush	7.7% 3/39 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	9.8% 4/41 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	3.2% 1/31 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Gastrointestinal disorders Diarrhea	2.6% 1/39 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	7.3% 3/41 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/31 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Respiratory, thoracic and mediastinal disorders Viral Upper Respiratory Infection	5.1% 2/39 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	4.9% 2/41 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.9% 1/35 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/31 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Anxiety	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	4.9% 2/41 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	9.7% 3/31 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Insomnia	15.4% 6/39 • Number of events 6 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	14.6% 6/41 • Number of events 6 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	25.8% 8/31 • Number of events 8 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Vivid Dreams/Nightmares	5.1% 2/39 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.4% 1/41 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	11.4% 4/35 • Number of events 5 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	12.9% 4/31 • Number of events 4 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Gastrointestinal disorders Stomachache	5.1% 2/39 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	3.2% 1/31 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Mood swings	5.1% 2/39 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.9% 1/35 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	3.2% 1/31 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Skin and subcutaneous tissue disorders Night Sweats	7.7% 3/39 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.4% 1/41 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.9% 1/35 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	6.5% 2/31 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Sleepiness	5.1% 2/39 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/35 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/31 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Fatigue	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	2.4% 1/41 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	6.5% 2/31 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Reproductive system and breast disorders Vaginal bleeding/spotting	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	14.3% 5/35 • Number of events 5 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	6.5% 2/31 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Gastrointestinal disorders Abdominal cramps/discomfort	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	8.6% 3/35 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	6.5% 2/31 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Psychiatric disorders Emotional lability	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	8.6% 3/35 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	3.2% 1/31 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Nervous system disorders Dizziness	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	3.2% 1/31 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Skin and subcutaneous tissue disorders Acne	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	3.2% 1/31 • Number of events 1 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Gastrointestinal disorders Vomiting	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	8.6% 3/35 • Number of events 3 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	6.5% 2/31 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/39 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/41 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	5.7% 2/35 • Number of events 2 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.	0.00% 0/31 • Adverse events were collected from the start of study drug administration, Day 1, through follow-up on Day 21.