Trial Outcomes & Findings for Hormones and Reduction in Co-users of Marijuana and Nicotine (NCT NCT02579421)

NCT ID: NCT02579421

Last Updated: 2020-06-26

Results Overview

Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 5 weeks. Baseline to week 4
• Results posted on: 2020-06-26

Participant Flow

Participant milestones

Measure	Progesterone - Males 200 mg progesterone BID Progesterone: generic progesterone	Placebo - Males placebo BID placebo: placebo	Progesterone - Females 200 mg progesterone BID	Placebo - Females pacebo BID
Overall Study STARTED	23	23	6	6
Overall Study COMPLETED	17	18	5	3
Overall Study NOT COMPLETED	6	5	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hormones and Reduction in Co-users of Marijuana and Nicotine

Baseline characteristics by cohort

Measure	Progesterone - Males n=23 Participants 200 mg progesterone BID Progesterone: generic progesterone	Placebo - Males n=23 Participants placebo BID placebo: placebo	Progesterone - Females n=6 Participants 200 mg progesterone BID Progesterone: generic progesterone	Placebo - Females n=6 Participants placebo BID placebo: placebo	Total n=58 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 11.3 • n=5 Participants	40.7 years STANDARD_DEVIATION 10.9 • n=7 Participants	34.0 years STANDARD_DEVIATION 7.7 • n=5 Participants	37.0 years STANDARD_DEVIATION 7.6 • n=4 Participants	38.8 years STANDARD_DEVIATION 10.5 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	46 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	23 participants n=5 Participants	23 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	58 participants n=21 Participants
Baseline MJ use per day	14.7 MJ use occasions per day STANDARD_DEVIATION 6.2 • n=5 Participants	13.9 MJ use occasions per day STANDARD_DEVIATION 8.6 • n=7 Participants	12.6 MJ use occasions per day STANDARD_DEVIATION 8.6 • n=5 Participants	12.0 MJ use occasions per day STANDARD_DEVIATION 4.4 • n=4 Participants	14.7 MJ use occasions per day STANDARD_DEVIATION 7.6 • n=21 Participants

PRIMARY outcome

Timeframe: 5 weeks. Baseline to week 4

Population: Some participant data was not included in the analysis because it was missing

Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit.

Outcome measures

Measure	Males - Progesterone n=17 Participants 200 mg progesterone BID Progesterone: generic progesterone	Males - Placebo n=18 Participants placebo BID placebo: placebo	Females - Progesterone n=5 Participants 200 mg progesterone BID Progesterone: generic progesterone	Females - Placebo n=3 Participants placebo BID placebo: placebo
Change in Marijuana Use as Defined by the TLFB	-1.7 MJ use occasions per day Standard Deviation 0.8	-1.4 MJ use occasions per day Standard Deviation 1.1	-0.9 MJ use occasions per day Standard Deviation 1.0	-2.9 MJ use occasions per day Standard Deviation 1.0

Adverse Events

Progesterone - Males

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo - Males

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Progesterone - Females

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo - Females

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. Sharon Allen

University of Minnesota

Phone: 612-624-0446

Email: allen001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place