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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA026514-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with alcohol use disorder (AUD).
The study aims to examine the effects of PREG on a) alcohol craving, mood and neuroendocrine reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily alcohol intake, craving, cognition and mood in men and women with AUD; and c) sex differences in all of these outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving 300mg PREG | Active Comparator | Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. |
|
| patients receiving 500mg PREG | Active Comparator | Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily. |
|
| placebo | Placebo Comparator | Patients randomly assigned to receive a placebo daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnenolone300 | Drug | 300mg |
| |
| Pregnenolone500 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Drinking Days | 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. | up to 8 weeks |
| Percent Heavy Drinking Days | 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. | up to 8 weeks |
| Number of Drinks Per Drinking Day | 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. | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Yale Stress Center: Yale University | New Haven | Connecticut | 06519 | United States | ||
| Yale Stress Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42258258 | Derived | Quinlan R, Gao H, Sinha R, Milivojevic V. Effects of the neuroactive steroid precursor pregnenolone on stress- and alcohol cue-provoked pain responses in individuals with alcohol use disorder. Exp Clin Psychopharmacol. 2026 Jun 8:10.1037/pha0000862. doi: 10.1037/pha0000862. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving 300mg PREG | Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. Pregnenolone300: 300mg |
| FG001 | Patients Receiving 500mg PREG | Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily. Pregnenolone500: 500mg |
| FG002 | Placebo | Patients randomly assigned to receive a placebo daily. Placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data represented here is from participants that started treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving 300mg PREG | Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. Pregnenolone300: 300mg |
| BG001 | Patients Receiving 500mg PREG | Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily. Pregnenolone500: 500mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Drinking Days | 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. | Participants who were randomized and received treatment. | Posted | Mean | Standard Deviation | percentage of drinking days | up to 8 weeks |
|
up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving 300mg PREG | Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. Pregnenolone300: 300mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE Version 5.0 | Systematic Assessment | Return to heavy drinking and had to be referred to inpatient detoxification. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nia Fogelman | Yale University | (917)861-9865 | nia.fogelman@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2021 | Oct 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2021 | Feb 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Randomized Double-blind, placebo-controlled, parallel design
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Double-blinded
| Drug |
500mg |
|
| Placebo | Drug | placebo |
|
| 8 week outcome period |
| Number of Participants With Treatment Emergent Adverse Events | 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. | up to 8 weeks |
| Pregnenolone Levels | Mean of blood levels of study drug assessed at 3 timepoints during the trial up to 8 weeks | up to 8 weeks |
| Weekly Negative Mood and Anxiety | 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. | assessed weekly, score at week 8 reported |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| BG002 | Placebo | Patients randomly assigned to receive a placebo daily. Placebo: placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Number of regular smokers | Count of Participants | Participants |
|
| Years of Alcohol Use | Mean | Standard Deviation | years |
|
| Drinking Severity (AUDIT) | A screening tool designed to identify individuals who may have alcohol-related problems or alcohol use disorders (AUD). Each question is scored on a scale of 0 to 4, with a total possible score ranging from 0 to 40. Higher scores indicate a greater likelihood of alcohol-related problems or AUD. | Mean | Standard Deviation | score on a scale |
|
| World Health Organization (WHO) Severity | Number of participants [percentage of group sample] for each level of World Health Organization Severity. Cut offs have been delineated differentially for men and women. For women: Low = fewer than 1.4 drinks/day; Moderate = 2.9- >1.4 drinks/day; High = 4.3- > 2.9 drinks/day; Very High = more than 4.3 drinks/day. For men: Low = fewer than 2.9 drinks/day; Moderate = 4.3- > 2.9 drinks/day; High = 7.1- > 4.3 drinks/day; Very High = more than 7.1 drinks/day. | Count of Participants | Participants |
|
| Baseline Clinical Institute Withdrawal Assessment (CIWA) Score | Total score 0-67. Lower scores indicate less withdrawal symptoms. | Mean | Standard Deviation | score on a scale |
|
| Lifetime Mood Disorder | Number of participants endorsing a Mood Disorder based on severe combined immunodeficiency (SCID) V criteria. Possible disorders include any past diagnosis of bipolar 1 or 2, major depressive disorder, persistent depressive disorder, or other/medically induced/substance induced depressive disorder. | Count of Participants | Participants |
|
| Lifetime Anxiety Disorder (including PTSD) | Number of participants endorsing an Anxiety Disorder based on SCID V criteria. | Count of Participants | Participants |
|
| Number of Participants Currently on Medications | Stabilized on medications for treatment of medical conditions. These included peripherally acting antihypertensives, asthma, gout, diabetes. Those stabilized on antidepressants were also included. | Count of Participants | Participants |
|
| Number of participants on depression medications | Count of Participants | Participants |
|
| Total number of medical conditions | Number | medical conditions |
|
| OG002 | Placebo | Patients randomly assigned to receive a placebo daily. Placebo: placebo |
|
|
|
| Primary | Percent Heavy Drinking Days | 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. | Participants who were randomized and received treatment. | Posted | Mean | Standard Deviation | percentage of heavy drinking days | up to 8 weeks |
|
|
|
|
| Primary | Number of Drinks Per Drinking Day | 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. | Participants who were randomized and received treatment. | Posted | Mean | Standard Deviation | drinks | up to 8 weeks |
|
|
|
|
| Secondary | Alcohol Craving | 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. | Participants who were randomized and received treatment. | Posted | Mean | Standard Deviation | score on a scale | 8 week outcome period |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events | 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. | Participants who were randomized and received treatment. | Posted | Count of Participants | Participants | up to 8 weeks |
|
|
|
| Secondary | Pregnenolone Levels | Mean of blood levels of study drug assessed at 3 timepoints during the trial up to 8 weeks | Participants who were randomized and received treatment. | Posted | Mean | Standard Deviation | ng/dL | up to 8 weeks |
|
|
|
|
| Secondary | Weekly Negative Mood and Anxiety | 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. | Participants who were randomized and received treatment. | Posted | Mean | Standard Deviation | score on a scale | assessed weekly, score at week 8 reported |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 10 |
| 29 |
| EG001 | Patients Receiving 500mg PREG | Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily. Pregnenolone500: 500mg | 0 | 30 | 0 | 30 | 9 | 30 |
| EG002 | Placebo | Patients randomly assigned to receive a placebo daily. Placebo: placebo | 0 | 27 | 1 | 27 | 7 | 27 |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specif | Injury, poisoning and procedural complications | CTCAE Version 5.0 | Systematic Assessment | Injury/Pain |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment | Stomach pain and nausea |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment | Infection and Inflammation |
|
| Immune system disorders - Other, specify | Immune system disorders | CTCAE Version 5.0 | Systematic Assessment | Cold and allergies |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE Version 5.0 | Systematic Assessment | Menstrual cramps |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE Version 5.0 | Systematic Assessment | Itching |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment | Restless leg |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE Version 5.0 | Systematic Assessment | Fatigue and Depression |
|
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|
| OCDS: Compulsive |
|
| <0.001 |
| Superiority |
| OCDS: Compulsive | Fisher Exact | 0.003 | Superiority |
|
| 0.089 |
| Superiority |