Phase 1
Completed N=10
Effect of Allopregnanolone on Stress-induced Craving
Alcohol Use Disorder
Source: ClinicalTrials.gov NCT04015869 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Alcohol Urge Questionnaire (AUQ) Pre-script — 24.45; 21.51; 19.15; 26.29 units on a scale
Summary
The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Urge Questionnaire (AUQ) Pre-script |
24.45; 21.51; 19.15; 26.29 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script |
1.4; 1.0; 1.0; 1.4 | — |
| PRIMARY Alcohol Urge Questionnaire (AUQ) Post-Script |
27.09; 21.50; 14.12; 24.70 | — |
| PRIMARY Alcohol Urge Questionnaire (AUQ) Recovery |
25.65; 25.76; 17.03; 24.70 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script |
1.6; 1.0; 1.6; 1.4 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery |
1.0; 1.0; 1.4; 1.2 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script |
3.16; 3.6; 3.0; 2.2 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script |
2.2; 3.6; 2.8; 2.8 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery |
3.2; 3.4; 2.4; 2.2 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script |
1.0; 1.0; 1.2; 1.6 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script |
1.6; 1.0; 1.4; 1.4 | — |
| PRIMARY The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery |
1.0; 1.0; 1.2; 1.2 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script |
6.4; 6.2 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Sedation Items |
10.6; 5.2 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%) |
5.8; 4.2 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day |
2.8; 6.4 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script |
25.8; 14.2 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Stimulation Items |
17.4; 15.6 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%) |
26.2; 31.4 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day |
17.6; 17.4 | — |
Eligibility Criteria
Inclusion Criteria
- Non-treatment seeking individuals with current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder (AUD)
- No current substance use disorder (except tobacco, alcohol, and marijuana)
- No current medical problems and normal electrocardiogram (ECG)
- For women, not pregnant as determined by pregnancy screening, not breast feeding.
Exclusion Criteria
- Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
- History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
- Liver function tests (ALT or AST) greater than 3 times normal
- weight >120kg
- renal impairment
- patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
Data sourced from ClinicalTrials.gov (NCT04015869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.