Trial Outcomes & Findings for Progesterone for Cannabis Withdrawal (NCT NCT03430050)

Last Updated: 2019-05-22

Results Overview

Participants took progesterone or placebo for 5 days. Salivary progesterone was measured each day. Change score was calculating by subtracting Day 1 progesterone levels from Day 5 progesterone levels.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

8 participants

Primary outcome timeframe

Day 1 and Day 5

Results posted on

2019-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Progesterone Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Progesterone: Progesterone capsule	Placebo Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule.
Overall Study STARTED	3	5
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progesterone for Cannabis Withdrawal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Progesterone n=3 Participants Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Progesterone: Progesterone capsule	Placebo n=5 Participants Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 5

Outcome measures

Outcome measures
Measure	Progesterone n=3 Participants Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Progesterone: Progesterone capsule	Placebo n=5 Participants Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule.
Change in Salivary Progesterone Level	237.86 pg/ml Standard Error 24.21	97.87 pg/ml Standard Error 14.67

PRIMARY outcome

Timeframe: Day 1 and Day 5

Participants took progesterone or placebo for 5 days. The Cannabis Withdrawal Scale was administered each day. The 19-item scale is used to measure cannabis withdrawal symptoms and negative impact on daily life. The item scores range from 0 - not at all to 10- Extremely. Scores on all items are summed to attain the scale score, so individuals can score between 0-190. Higher scores indicates more severe withdrawal symptoms and greater negative impact. Change score was calculating by subtracting Day 1 CWS scores from Day 5 CWS scores. A positive change score reflects an increase in withdrawal symptoms, while a negative change score reflects a decrease in withdrawal symptoms.

Outcome measures

Outcome measures
Measure	Progesterone n=3 Participants Prometrium 200mg. Take one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Progesterone: Progesterone capsule	Placebo n=5 Participants Placebo. ake one pill in the evening on day 1 with water. Take one pill twice a day on days 2-4. Take one pill on morning day 5. Placebo: Placebo capsule. Manufactured to mimic progesterone 200mg capsule.
Change in Cannabis Withdrawal Scale Score.	29.08 units on a scale Standard Error 4.15	20.41 units on a scale Standard Error 3.18

Adverse Events

Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sherman

MUSC

Phone: 843-792-8174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place