Trial Outcomes & Findings for Progesterone for the Treatment of Cocaine Dependence - 1 (NCT NCT00218257)

NCT ID: NCT00218257

Last Updated: 2020-10-08

Results Overview

During 1 inpatient testing day, participants were given the opportunity to spend 5 earned tokens on either an active dose of cocaine or to keep the tokens for a $5 reward for each token. Decisions were solicited every 30 minutes. Outcome measure is reported as the percent of 5 decisions for which the participant chose to self-administer cocaine. 0% indicates that all 5 tokens were retained and traded for monetary reward. 100% indicates that the participant spent all 5 tokens on cocaine for self-administration. On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine (amount of cocaine insufficient for psychoactive effect) or a $5 monetary reward. 0% indicates that all 5 tokens were retained and traded for monetary reward. 100% indicates that the participant spent all 5 tokens on inactive doses of cocaine for self-administration. The order of days (active or inactive cocaine dosage) was random.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2020-10-08

Participant Flow

96 participants were consented. 45 participants began the first in-hospital study visit. The remaining 41 participants were lost to follow-up or chose not to participant after consenting. 45 participants completed the first 4-day inpatient study visit. 38 participants began and completed the second inpatient study visit.

Participant milestones

Measure	Progesterone, Then Placebo	Placebo, Then Progesterone
Intervention 1 STARTED	23	22
Intervention 1 COMPLETED	23	22
Intervention 1 NOT COMPLETED	0	0
Period Between Visit 1 and 2 STARTED	23	22
Period Between Visit 1 and 2 COMPLETED	19	19
Period Between Visit 1 and 2 NOT COMPLETED	4	3
Intervention 2 STARTED	19	19
Intervention 2 COMPLETED	19	19
Intervention 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Progesterone, Then Placebo	Placebo, Then Progesterone
Period Between Visit 1 and 2 Lost to Follow-up	4	3

Baseline Characteristics

Progesterone for the Treatment of Cocaine Dependence - 1

Baseline characteristics by cohort

Measure	All Participants n=45 Participants Cross-over design; all participants who completed the first of two inpatient study visits are pooled and reported here
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40 Years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Only participants who completed both 4-day in-hospital testing visits are included in outcome measure reporting.

During 1 inpatient testing day, participants were given the opportunity to spend 5 earned tokens on either an active dose of cocaine or to keep the tokens for a $5 reward for each token. Decisions were solicited every 30 minutes. Outcome measure is reported as the percent of 5 decisions for which the participant chose to self-administer cocaine. 0% indicates that all 5 tokens were retained and traded for monetary reward. 100% indicates that the participant spent all 5 tokens on cocaine for self-administration.

On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine (amount of cocaine insufficient for psychoactive effect) or a $5 monetary reward. 0% indicates that all 5 tokens were retained and traded for monetary reward. 100% indicates that the participant spent all 5 tokens on inactive doses of cocaine for self-administration.

The order of days (active or inactive cocaine dosage) was random.

Outcome measures

Measure	Progesterone n=38 Participants Progesterone (200mg, twice daily)	Placebo n=38 Participants Placebo (given twice daily)
Decision to Self-Administer Cocaine Active Cocaine Dose	66 percent of available doses Standard Error 3.5	66 percent of available doses Standard Error 3.3
Decision to Self-Administer Cocaine Inactive Cocaine Dose	32 percent of available doses Standard Error 3.5	32 percent of available doses Standard Error 3.3

SECONDARY outcome

Timeframe: 4 days

Population: Only participants who completed both 4-day in-hospital testing visits are included in outcome measure reporting.

During 1 inpatient testing day, participants were given the opportunity to spend 5 tokens on either an active dose of cocaine or to keep the tokens for a $5 reward each. Decisions were solicited every 30 minutes. There was a total of 5 decisions solicited. On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine or a monetary reward. The order of days (active or inactive cocaine dosage) was random. These 2 testing days were completed during a 4-day in-hospital testing session under the progesterone condition and placebo condition. Order of progesterone and placebo conditions were randomized.

Heart rate was taken 2.5 minutes following administration of cocaine (active or inactive dosage). Up to 5 HR measurements were recorded based on participant decision to self-administer cocaine or not. Mean across up to 5 measures was calculated. Outcome is reported as the mean of mean measures during each of 4 study conditions.

Outcome measures

Measure	Progesterone n=38 Participants Progesterone (200mg, twice daily)	Placebo n=38 Participants Placebo (given twice daily)
Heart Rate Active Cocaine Dose	87.9 beats per minute Standard Deviation 16.0	87.2 beats per minute Standard Deviation 16.3
Heart Rate Inactive Cocaine Dose	77.6 beats per minute Standard Deviation 13.0	74.6 beats per minute Standard Deviation 12.1

SECONDARY outcome

Timeframe: 4 days

Population: Only participants who completed both 4-day in-hospital testing visits are included in outcome measure reporting.

During 1 inpatient testing day, participants were given the opportunity to spend 5 tokens on either an active dose of cocaine or to keep the tokens for a $5 reward each. Decisions were solicited every 30 minutes. There was a total of 5 decisions solicited. On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine or a monetary reward. The order of days (active or inactive cocaine dosage) was random. These 2 testing days were completed during a 4-day in-hospital testing session under the progesterone condition and placebo condition. Progesterone and placebo conditions were randomized.

Blood pressure was taken 2.5 minutes following administration of cocaine (active or inactive dosage). Up to 5 BP measurements were recorded based on participant decision to self-administer cocaine or not. Mean across up to 5 measures was calculated. Outcome is reported as the mean of mean measures during each of 4 study conditions.

Outcome measures

Measure	Progesterone n=38 Participants Progesterone (200mg, twice daily)	Placebo n=38 Participants Placebo (given twice daily)
Systolic Blood Pressure Active Cocaine Dose	129.9 mmHG Standard Deviation 19.8	131.8 mmHG Standard Deviation 18.5
Systolic Blood Pressure Inactive Cocaine Dose	117.4 mmHG Standard Deviation 16.6	120.2 mmHG Standard Deviation 17.6

SECONDARY outcome

Timeframe: 4 days

Population: Only participants who completed both 4-day in-hospital testing visits are included in outcome measure reporting.

During 1 inpatient testing day, participants were given the opportunity to spend 5 tokens on either an active dose of cocaine or to keep the tokens for a $5 reward each. Decisions were solicited every 30 minutes. There was a total of 5 decisions solicited. On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine or a monetary reward. The order of days (active or inactive cocaine dosage) was random. These 2 testing days were completed during a 4-day in-hospital testing session under the progesterone condition and placebo condition. Progesterone and placebo conditions were randomized.

Blood pressure was taken 2.5 minutes following administration of cocaine (active or inactive dosage). Up to 5 BP measurements were recorded based on participant decision to self-administer cocaine or not. Mean across up to 5 measures was calculated. Outcome is reported as the mean of mean measures during each of 4 study conditions.

Outcome measures

Measure	Progesterone n=38 Participants Progesterone (200mg, twice daily)	Placebo n=38 Participants Placebo (given twice daily)
Diastolic Blood Pressure Active Cocaine Dose	77.6 mmHG Standard Deviation 12.6	78.6 mmHG Standard Deviation 10.7
Diastolic Blood Pressure Inactive Cocaine Dose	71.3 mmHG Standard Deviation 8.8	72.2 mmHG Standard Deviation 10.1

SECONDARY outcome

Timeframe: 4 days

Population: Only participants who completed both 4-day in-hospital testing visits are included in outcome measure reporting.

During 1 inpatient testing day, participants were given the opportunity to spend 5 tokens on either an active dose of cocaine or to keep the tokens for a $5 reward each. Decisions were solicited every 30 minutes. There was a total of 5 decisions solicited. On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine or a monetary reward. The order of days (active or inactive cocaine dosage) was random. These 2 testing days were completed during a 5-day in-hospital testing session under the progesterone condition and placebo condition. Progesterone and placebo conditions were randomized.

Participants were asked to rate cocaine craving on a scale of 0-5 prior to administration of cocaine (active or inactive dose). Lower scores indicate less cocaine craving.

Outcome measures

Measure	Progesterone n=38 Participants Progesterone (200mg, twice daily)	Placebo n=38 Participants Placebo (given twice daily)
Cocaine Craving Active Cocaine Dose	3.99 score on a scale Standard Error .17	4.02 score on a scale Standard Error .16
Cocaine Craving Inactive Cocaine Dose	2.06 score on a scale Standard Error .16	1.38 score on a scale Standard Error .17

Adverse Events

Progesterone

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Progesterone n=38 participants at risk Progesterone (200mg given twice daily)	Placebo n=38 participants at risk Placebo (given twice daily)
Nervous system disorders Seizure	2.6% 1/38 • Number of events 1 • 2 months	0.00% 0/38 • 2 months

Other adverse events

Measure	Progesterone n=38 participants at risk Progesterone (200mg given twice daily)	Placebo n=38 participants at risk Placebo (given twice daily)
Nervous system disorders Headache	18.4% 7/38 • 2 months	0.00% 0/38 • 2 months
Gastrointestinal disorders GI Upset	18.4% 7/38 • Number of events 7 • 2 months	0.00% 0/38 • 2 months

Additional Information

Dr. Sheila Specker

University of Minnesota

Phone: 612-273-9806

Email: speck001@umn.edu

Results disclosure agreements

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