Phase 2
Completed N=15
Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
Alcohol Abstinence
Source: ClinicalTrials.gov NCT03137082 ↗
Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jun 2024
Primary outcomePrimary: Percentage of Days Abstinent — 74.7; 50.6 percentage of days abstinent — p=<0.03
Summary
Guanfacine may preferentially reduce craving and improve cognitive control in women with Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the objectives of this study are to conduct a 10-week out-patient clinical trial to examine the effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in women with AUD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Days Abstinent |
74.7; 50.6 | <0.03 sig |
| PRIMARY Percentage of Heavy Drinking Days |
15.5; 30.6 | 0.1 |
| PRIMARY Alcohol Consumption (Percentage of Negative Urines) |
45.3; 35.2 | — |
| SECONDARY Mood (Anxiety) |
-8.2; -0.75 | 0.01 sig |
| SECONDARY Mood (Depression) |
-13.9; 0.03 | 0.001 sig |
| SECONDARY Alcohol Craving |
-1.6; -1.9 | 0.5 |
| SECONDARY Emotion Regulation (Difficulties in Impulse Control) |
-2.8; 0.85 | <.03 sig |
| SECONDARY Emotion Regulation (Difficulties With Engaging in Goal Related Behavior) |
-3.0; 0.95 | 0.1 |
| SECONDARY Emotion Regulation (Difficulties With Emotional Clarity) |
-2.3; -0.71 | <0.3 |
| SECONDARY Emotion Regulation (Limited Access to Emotion Regulation Strategies) |
-5.1; -0.28 | 0.04 sig |
| SECONDARY Emotion Regulation (Difficulties With Emotional Awareness) |
-1.6; -2.9 | 0.4 |
| SECONDARY Emotion Regulation (Non-Acceptance of Emotional Responses) |
-6.4; -0.88 | 0.08 |
| SECONDARY Emotion Regulation (Total Score) |
-19.8; -4.5 | 0.2 |
Eligibility Criteria
Inclusion Criteria
- Must meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM- V) criteria for moderate to severe Alcohol Use Disorder (AUD),
- Must produce positive urine toxicology screens on admission to study
- Must demonstrate good health as verified by screening examination
- Must be able to read English and complete study evaluations
- Must be able to provide informed written and verbal consent
Exclusion Criteria
- Meeting current use disorder for any other psychoactive substance, excluding nicotine.
- Having any other current Axis I psychiatric disorders or medical conditions requiring treatment or medication
- EKG evidence at baseline screening of any clinically significant conduction abnormalities including a Bazlett's QTc (corrected QT interval) of >470 msec.
- Must not be on monophasic contraceptives, nursing or pregnant.
Data sourced from ClinicalTrials.gov (NCT03137082). 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.