Trial Outcomes & Findings for The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders (NCT NCT03953612)
NCT ID: NCT03953612
Last Updated: 2024-07-03
Results Overview
Cocaine craving assessed in a laboratory experiment with exposure to stress, cocaine cue and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo. Cocaine craving was assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale that ranges in mean score from 1 to 7, where a higher score indicates higher craving. Data presented here is craving change in stress relative to neutral and craving change in cue relative to neutral, where the possible range in mean change score is -6 to +6.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
58 participants
Primary outcome timeframe
Experiment during treatment week 2
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
PREG 300 mg/Day
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
18
|
19
|
|
Overall Study
Intent to Treat Sample Included in Analyses
|
20
|
17
|
18
|
|
Overall Study
Dropout Weeks 1-3
|
1
|
1
|
0
|
|
Overall Study
Dropout Weeks 4-12
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
18
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
PREG 300 mg/Day
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Overall Study
Randomized but did not start
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
Baseline Characteristics
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Baseline characteristics by cohort
| Measure |
PREG 300 mg/Day
n=20 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=17 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=18 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.05 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
46.47 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
47.17 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
47.27 years
STANDARD_DEVIATION 10.48 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
18 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Years of Education
|
12.5 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
12.35 years
STANDARD_DEVIATION 1.87 • n=7 Participants
|
12.56 years
STANDARD_DEVIATION 1.58 • n=5 Participants
|
12.47 years
STANDARD_DEVIATION 1.59 • n=4 Participants
|
|
Number of Smokers
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Experiment during treatment week 2Population: A subset of participants from the full study sample completed the experimental component of stress and cocaine cue provocation.
Cocaine craving assessed in a laboratory experiment with exposure to stress, cocaine cue and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo. Cocaine craving was assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale that ranges in mean score from 1 to 7, where a higher score indicates higher craving. Data presented here is craving change in stress relative to neutral and craving change in cue relative to neutral, where the possible range in mean change score is -6 to +6.
Outcome measures
| Measure |
PREG 300 mg/Day
n=8 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=11 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=11 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Craving Change in Stress and Cue Relative to Neutral
Stress Craving Change
|
3.035 score on a scale
Standard Deviation 1.34
|
-0.486 score on a scale
Standard Deviation 1.153
|
3.959 score on a scale
Standard Deviation 1.115
|
|
Craving Change in Stress and Cue Relative to Neutral
Cue Craving Change
|
0.031 score on a scale
Standard Deviation 1.313
|
-1.775 score on a scale
Standard Deviation 1.126
|
4.835 score on a scale
Standard Deviation 1.118
|
SECONDARY outcome
Timeframe: Experiment during treatment week 2Population: A subset of participants from the full study sample completed the experimental component of stress and cocaine cue provocation
Anxiety assessed in laboratory experiment with exposure to stress, cocaine cue and neutral control condition in participants receiving PREG (300mg; 500mg) vs. Placebo treatment. Anxiety was assessed using a 10-point visual analog scale (VAS) in which 0="not at all" and 10="extremely high", with the mean score ranging from 0 to 10, and where higher score means higher anxiety. Data presented here is anxiety change in stress relative to neutral and anxiety change in cue relative to neutral, where the possible range in mean change score is -10 to +10.
Outcome measures
| Measure |
PREG 300 mg/Day
n=8 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=11 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=11 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Anxiety Change in Stress and Cue Relative to Neutral
Stress Anxiety Change
|
0.757 score on a scale
Standard Deviation 0.309
|
0.118 score on a scale
Standard Deviation 0.269
|
1.334 score on a scale
Standard Deviation 0.263
|
|
Anxiety Change in Stress and Cue Relative to Neutral
Cue Anxiety Change
|
-0.305 score on a scale
Standard Deviation 0.302
|
0.199 score on a scale
Standard Deviation 0.261
|
0.959 score on a scale
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Experiment during treatment week 2Population: A subset of participants from the full study sample completed the experimental component of stress and cocaine cue provocation
Plasma was collected at each laboratory session to measure cortisol level and assess change in cortisol response to stress and cocaine cue relative neutral imagery condition exposure. Data presented here are change in cortisol level (mg/dl) in stress relative to neutral condition and cue relative to neutral condition.
Outcome measures
| Measure |
PREG 300 mg/Day
n=8 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=11 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=11 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Cortisol Level Change in Stress and Cue Relative to Neutral
Stress Cortisol Level Change
|
-0.3 mg/dl
Standard Deviation 0.55
|
-0.52 mg/dl
Standard Deviation 0.64
|
0.71 mg/dl
Standard Deviation 0.9
|
|
Cortisol Level Change in Stress and Cue Relative to Neutral
Cue Cortisol Level Change
|
0 mg/dl
Standard Deviation 0.45
|
-0.07 mg/dl
Standard Deviation 0.73
|
0.58 mg/dl
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: between weeks 2-3 of treatmentPopulation: A subset of participants from the full study sample completed the experimental component of stress and alcohol cue provocation
Blood plasma concentration of pregnenolone in two doses of PREG (300mg; 500mg), and matching placebo, assessed over a 24 hour period.
Outcome measures
| Measure |
PREG 300 mg/Day
n=8 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=11 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=11 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Pregnenolone Concentration
|
1.09 ng/mL
Standard Deviation 0.194
|
1.54 ng/mL
Standard Deviation 0.147
|
0.5 ng/mL
Standard Deviation 0.146
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 8 weeksPopulation: Intent to Treat Sample Included in Analyses n=55
Mean dollar amount of cocaine per use day was assessed by daily self report on the Timeline Followback Substance Use Calendar and corroborated by daily self-reporting on smartphone (measurement unit in dollars).
Outcome measures
| Measure |
PREG 300 mg/Day
n=20 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=17 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=18 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Cocaine Dollar Amount During Trial Period
|
12.3 dollars
Standard Deviation 17.57
|
26.44 dollars
Standard Deviation 20.59
|
28.28 dollars
Standard Deviation 43.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 8 weeksPopulation: Intent to Treat Sample Included in Analyses n=55
The mean percent cocaine days as assessed by self report on daily smartphone monitoring and corroborated by the Timeline Followback Substance Use Calendar over the 8 week period.
Outcome measures
| Measure |
PREG 300 mg/Day
n=20 Participants
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=17 Participants
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=18 Participants
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Mean Percent Cocaine Days
|
19.9 percent days
Standard Error 20.46
|
35.12 percent days
Standard Error 20.05
|
28.61 percent days
Standard Error 26.19
|
Adverse Events
PREG 300 mg/Day
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
PREG 500 mg/Day
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Patients Receiving Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PREG 300 mg/Day
n=20 participants at risk
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=17 participants at risk
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=18 participants at risk
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • up to 8 weeks
|
0.00%
0/17 • up to 8 weeks
|
0.00%
0/18 • up to 8 weeks
|
Other adverse events
| Measure |
PREG 300 mg/Day
n=20 participants at risk
Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
PREG 500 mg/Day
n=17 participants at risk
Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
|
Patients Receiving Placebo
n=18 participants at risk
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
2/20 • up to 8 weeks
|
11.8%
2/17 • up to 8 weeks
|
16.7%
3/18 • up to 8 weeks
|
|
General disorders
Injury/Pain
|
25.0%
5/20 • up to 8 weeks
|
17.6%
3/17 • up to 8 weeks
|
11.1%
2/18 • up to 8 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.0%
1/20 • up to 8 weeks
|
5.9%
1/17 • up to 8 weeks
|
5.6%
1/18 • up to 8 weeks
|
|
General disorders
Inflammation/Allergy
|
5.0%
1/20 • up to 8 weeks
|
5.9%
1/17 • up to 8 weeks
|
5.6%
1/18 • up to 8 weeks
|
|
General disorders
Infection/Immune System
|
10.0%
2/20 • up to 8 weeks
|
17.6%
3/17 • up to 8 weeks
|
5.6%
1/18 • up to 8 weeks
|
|
Psychiatric disorders
Suicidal Thoughts
|
0.00%
0/20 • up to 8 weeks
|
0.00%
0/17 • up to 8 weeks
|
5.6%
1/18 • up to 8 weeks
|
|
Nervous system disorders
Lightheadedness
|
5.0%
1/20 • up to 8 weeks
|
0.00%
0/17 • up to 8 weeks
|
0.00%
0/18 • up to 8 weeks
|
|
General disorders
Fatigue
|
0.00%
0/20 • up to 8 weeks
|
5.9%
1/17 • up to 8 weeks
|
5.6%
1/18 • up to 8 weeks
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/20 • up to 8 weeks
|
11.8%
2/17 • up to 8 weeks
|
5.6%
1/18 • up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place