Trial Outcomes & Findings for The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders (NCT NCT03872128)
NCT ID: NCT03872128
Last Updated: 2024-02-05
Results Overview
The mean percent drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
91 participants
Primary outcome timeframe
up to 8 weeks
Results posted on
2024-02-05
Participant Flow
Participant milestones
| Measure |
Patients Receiving 300mg PREG
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
|
Overall Study
Began Treatment
|
29
|
30
|
27
|
|
Overall Study
COMPLETED
|
27
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
12
|
Reasons for withdrawal
| Measure |
Patients Receiving 300mg PREG
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Overall Study
Dropped out before treatment
|
1
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
8
|
Baseline Characteristics
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Baseline characteristics by cohort
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
44.8 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
47.2 years
STANDARD_DEVIATION 13.3 • n=206 Participants
|
46.4 years
STANDARD_DEVIATION 12.2 • n=157 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
31 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
55 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
80 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
27 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
49 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
30 participants
n=107 Participants
|
27 participants
n=206 Participants
|
86 participants
n=157 Participants
|
|
Years of Education
|
14 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
14.6 years
STANDARD_DEVIATION 2.6 • n=107 Participants
|
14.6 years
STANDARD_DEVIATION 2.6 • n=206 Participants
|
14.4 years
STANDARD_DEVIATION 2.6 • n=157 Participants
|
|
Number of regular smokers
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
34 Participants
n=157 Participants
|
|
Years of Alcohol Use
|
21.9 years
STANDARD_DEVIATION 14.9 • n=99 Participants
|
17.3 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
20 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
19.7 years
STANDARD_DEVIATION 12.7 • n=157 Participants
|
|
Drinking Severity (AUDIT)
|
17 score on a scale
STANDARD_DEVIATION 6.7 • n=99 Participants
|
19.2 score on a scale
STANDARD_DEVIATION 7.5 • n=107 Participants
|
20.3 score on a scale
STANDARD_DEVIATION 6.7 • n=206 Participants
|
18.8 score on a scale
STANDARD_DEVIATION 7 • n=157 Participants
|
|
World Health Organization (WHO) Severity
Low
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=157 Participants
|
|
World Health Organization (WHO) Severity
Moderate
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
|
World Health Organization (WHO) Severity
High
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
|
World Health Organization (WHO) Severity
Very High
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
|
Baseline Clinical Institute Withdrawal Assessment (CIWA) Score
|
5.1 score on a scale
STANDARD_DEVIATION 4.7 • n=99 Participants
|
4 score on a scale
STANDARD_DEVIATION 4.8 • n=107 Participants
|
4.8 score on a scale
STANDARD_DEVIATION 5.8 • n=206 Participants
|
4.6 score on a scale
STANDARD_DEVIATION 5.1 • n=157 Participants
|
|
Lifetime Mood Disorder
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
|
Lifetime Anxiety Disorder (including PTSD)
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=157 Participants
|
|
Number of Participants Currently on Medications
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
46 Participants
n=157 Participants
|
|
Number of participants on depression medications
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=157 Participants
|
|
Total number of medical conditions
|
17 medical conditions
n=99 Participants
|
15 medical conditions
n=107 Participants
|
12 medical conditions
n=206 Participants
|
44 medical conditions
n=157 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: Participants who were randomized and received treatment.
The mean percent drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Percent Drinking Days
|
38.5 percentage of drinking days
Standard Deviation 5.1
|
46.6 percentage of drinking days
Standard Deviation 5.7
|
53 percentage of drinking days
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: Participants who were randomized and received treatment.
The mean percent heavy drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Percent Heavy Drinking Days
|
15.2 percentage of heavy drinking days
Standard Deviation 3.6
|
23.7 percentage of heavy drinking days
Standard Deviation 5.1
|
22.9 percentage of heavy drinking days
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: Participants who were randomized and received treatment.
Average number of drinks per drinking day as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Number of Drinks Per Drinking Day
|
1.7 drinks
Standard Deviation 0.3
|
2.5 drinks
Standard Deviation 0.5
|
2.3 drinks
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 8 week outcome periodPopulation: Participants who were randomized and received treatment.
Alcohol craving assessed using the weekly Obsessive Compulsive Drinking Scale (OCDS). This 14-item scale is a quick and reliable self-rating instrument that provides a total and two subscale scores that measure some cognitive aspects of alcohol "craving". Obsessive subscale is the summation of items 1-6 with score range 0-24. Compulsive subscale is the summation of items 7-14 with score range 0-32. Total score range 0-40. Higher scores indicate more obsessions and compulsions with alcohol.
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Alcohol Craving
OCDS: Total
|
13.8 score on a scale
Standard Deviation 0.5
|
16.2 score on a scale
Standard Deviation 0.6
|
20.4 score on a scale
Standard Deviation 0.7
|
|
Alcohol Craving
OCDS: Obsessive
|
4 score on a scale
Standard Deviation 0.2
|
5.8 score on a scale
Standard Deviation 0.3
|
6.9 score on a scale
Standard Deviation 0.4
|
|
Alcohol Craving
OCDS: Compulsive
|
9.8 score on a scale
Standard Deviation 0.3
|
10.4 score on a scale
Standard Deviation 0.4
|
13.5 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: Participants who were randomized and received treatment.
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial. Data presented here is the number of participants that had any adverse events while on study.
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
10 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: Participants who were randomized and received treatment.
Mean of blood levels of study drug assessed at 3 timepoints during the trial up to 8 weeks
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Pregnenolone Levels
|
5.46 ng/dL
Standard Deviation 0.79
|
6.21 ng/dL
Standard Deviation 0.66
|
2.42 ng/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: assessed weekly, score at week 8 reportedPopulation: Participants who were randomized and received treatment.
The Hospital Anxiety and Depression Scale (HADS) will be used; it has 2 subscales (one for depression and one for anxiety) each with 7 items. It is a brief measure of generalized symptoms of anxiety and fear. Respondents indicate how they currently feel and responses are rated on a 4-point Likert scale with total score range from 0 to 21. Total scores are the sum of all items. Total scores are reported. Higher scores indicate higher levels of depression or anxiety.
Outcome measures
| Measure |
Patients Receiving 300mg PREG
n=29 Participants
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 Participants
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 Participants
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Weekly Negative Mood and Anxiety
HADS-Depression
|
4.53 score on a scale
Standard Deviation 0.26
|
4.85 score on a scale
Standard Deviation 0.24
|
6.55 score on a scale
Standard Deviation 0.35
|
|
Weekly Negative Mood and Anxiety
HADS-Anxiety
|
5.36 score on a scale
Standard Deviation 0.24
|
6.49 score on a scale
Standard Deviation 0.27
|
7.31 score on a scale
Standard Deviation 0.32
|
Adverse Events
Patients Receiving 300mg PREG
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Patients Receiving 500mg PREG
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Receiving 300mg PREG
n=29 participants at risk
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 participants at risk
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 participants at risk
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/29 • up to 8 weeks
|
0.00%
0/30 • up to 8 weeks
|
3.7%
1/27 • up to 8 weeks
|
Other adverse events
| Measure |
Patients Receiving 300mg PREG
n=29 participants at risk
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Pregnenolone300: 300mg
|
Patients Receiving 500mg PREG
n=30 participants at risk
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
Pregnenolone500: 500mg
|
Placebo
n=27 participants at risk
Patients randomly assigned to receive a placebo daily.
Placebo: placebo
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
10.3%
3/29 • up to 8 weeks
|
6.7%
2/30 • up to 8 weeks
|
7.4%
2/27 • up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
2/29 • up to 8 weeks
|
3.3%
1/30 • up to 8 weeks
|
3.7%
1/27 • up to 8 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specif
|
10.3%
3/29 • up to 8 weeks
|
13.3%
4/30 • up to 8 weeks
|
0.00%
0/27 • up to 8 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.9%
2/29 • up to 8 weeks
|
3.3%
1/30 • up to 8 weeks
|
7.4%
2/27 • up to 8 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.3%
3/29 • up to 8 weeks
|
3.3%
1/30 • up to 8 weeks
|
3.7%
1/27 • up to 8 weeks
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.4%
1/29 • up to 8 weeks
|
3.3%
1/30 • up to 8 weeks
|
0.00%
0/27 • up to 8 weeks
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
3.4%
1/29 • up to 8 weeks
|
6.7%
2/30 • up to 8 weeks
|
0.00%
0/27 • up to 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/29 • up to 8 weeks
|
3.3%
1/30 • up to 8 weeks
|
0.00%
0/27 • up to 8 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.4%
1/29 • up to 8 weeks
|
0.00%
0/30 • up to 8 weeks
|
0.00%
0/27 • up to 8 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/29 • up to 8 weeks
|
3.3%
1/30 • up to 8 weeks
|
3.7%
1/27 • up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place