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The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Phase 1 trial testing Pregnenolone300 in Alcohol Use Disorder in 91 participants. Completed in 1 August 2023.
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 91 |
| Start date | 27 September 2018 |
| Primary completion | 1 November 2022 |
| Estimated completion | 1 August 2023 |
| Sites | 2 locations across United States |
Yale University
Adults 18 to 68, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 38.5 | ± 5.1 |
| Patients Receiving 500mg PREG | 46.6 | ± 5.7 |
| Placebo | 53 | ± 6.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 15.2 | ± 3.6 |
| Patients Receiving 500mg PREG | 23.7 | ± 5.1 |
| Placebo | 22.9 | ± 5.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 1.7 | ± 0.3 |
| Patients Receiving 500mg PREG | 2.5 | ± 0.5 |
| Placebo | 2.3 | ± 0.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 13.8 | ± 0.5 |
| Patients Receiving 500mg PREG | 16.2 | ± 0.6 |
| Placebo | 20.4 | ± 0.7 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 4 | ± 0.2 |
| Patients Receiving 500mg PREG | 5.8 | ± 0.3 |
| Placebo | 6.9 | ± 0.4 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 9.8 | ± 0.3 |
| Patients Receiving 500mg PREG | 10.4 | ± 0.4 |
| Placebo | 13.5 | ± 0.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 10 | |
| Patients Receiving 500mg PREG | 9 | |
| Placebo | 8 |
Mean of blood levels of study drug assessed at 3 timepoints during the trial up to 8 weeks
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 5.46 | ± 0.79 |
| Patients Receiving 500mg PREG | 6.21 | ± 0.66 |
| Placebo | 2.42 | ± 0.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 4.53 | ± 0.26 |
| Patients Receiving 500mg PREG | 4.85 | ± 0.24 |
| Placebo | 6.55 | ± 0.35 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Receiving 300mg PREG | 5.36 | ± 0.24 |
| Patients Receiving 500mg PREG | 6.49 | ± 0.27 |
| Placebo | 7.31 | ± 0.32 |
Time frame: up to 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Patients Receiving 300mg P… | Patients Receiving 500mg P… | Placebo |
|---|---|---|---|---|
| General disorders and administration site conditions - Other, specify | General disorders | — | — | — |
| Reaction | System | Patients Receiving 300mg P… | Patients Receiving 500mg P… | Placebo |
|---|---|---|---|---|
| Injury, poisoning and procedural complications - Other, specif | Injury, poisoning and procedural complications | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — | — |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | — | — | — |
| Immune system disorders - Other, specify | Immune system disorders | — | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — | — | — |
| General disorders and administration site conditions - Other, specify | General disorders | — | — | — |
Most-reported serious reactions: General disorders and administration site conditions - Other, specify.
Data from ClinicalTrials.gov NCT03872128 adverse events section.
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).
4 peer-reviewed publications reference this trial (live from Europe PMC):
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