Alcohol Use DisorderPhase 1NCT03872128
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
A Phase 1 study testing Pregnenolone300 and Pregnenolone500 in people with Alcohol Use Disorder, run by Yale University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Pregnenolone300 and Pregnenolone500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Sep 2018to 1 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female individuals, ages 18 to 68.
- Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.
- Subject has voluntarily given informed consent and signed the informed consent document.
- Able to read English and complete study evaluations.
Who cannot join
- Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
- Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.
- Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).
- Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.
- Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.
- Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
- Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Yale Stress Center: Yale University
New Haven, Connecticut, 06519
Yale Stress Center
New Haven, Connecticut, 06519
About this study
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).
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Pregnenolone300, Pregnenolone500, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnenolone300Drug
300mg
Pregnenolone500Drug
500mg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| patients receiving 300mg PREG | Active comparator | Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. Receives: Drug: Pregnenolone300 |
| patients receiving 500mg PREG | Active comparator | Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily. Receives: Drug: Pregnenolone500 |
| placebo | Placebo comparator | Patients randomly assigned to receive a placebo daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: up to 8 weeks
Pregnenolone Levels
Mean of blood levels of study drug assessed at 3 timepoints during the trial up to 8 weeks
Measured: 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.
Measured: assessed weekly, score at week 8 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start27 Sep 2018
- Primary completion1 Nov 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double-blind, placebo-controlled, parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872128
- Sponsor's protocol ID
- 1608018179
- Other IDs
- 1R01AA026514-01A1
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2019
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 42258258
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT03872128
- Acronym / sponsor ID
- 1608018179
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Double-blind, placebo-controlled, parallel design
| Arm | Type | Receives |
|---|---|---|
| patients receiving 300mg PREG | Active comparator | Drug: Pregnenolone300Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. |
| patients receiving 500mg PREG | Active comparator | Drug: Pregnenolone500Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily. |
| placebo | Placebo comparator | Drug: PlaceboPatients randomly assigned to receive a placebo daily. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female individuals, ages 18 to 68.
- Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.
- Subject has voluntarily given informed consent and signed the informed consent document.
- Able to read English and complete study evaluations.
Key exclusion criteria (7 listed)
- Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
- Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.
- Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).
- Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.
- Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnenolone300300mg | Drug | patients receiving 300mg PREG |
| Pregnenolone500500mg | Drug | patients receiving 500mg PREG |
| Placeboplacebo | Drug | placebo |
Primary outcome
Percent Drinking Days
Time frame: up to 8 weeks
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.
Percent Heavy Drinking Days
Time frame: up to 8 weeks
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.
Number of Drinks Per Drinking Day
Time frame: up to 8 weeks
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.
4 secondary outcomes
Alcohol Craving
Time frame: 8 week outcome period
Number of Participants With Treatment Emergent Adverse Events
Time frame: up to 8 weeks
Pregnenolone Levels
Time frame: up to 8 weeks
Weekly Negative Mood and Anxiety
Time frame: assessed weekly, score at week 8 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42258258Quinlan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregnenolone300 and Pregnenolone500 in people with Alcohol Use Disorder, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Drinking Days (time frame: up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.