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Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
Phase 1, PHASE2 trial testing Guanfacine XR 3mgs/daily in Alcohol Abstinence in 32 participants. Completed in 31 March 2021.
| Lead sponsor | Stony Brook University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 12 July 2017 |
| Primary completion | 31 March 2021 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across United States |
Stony Brook University
Adults 18 to 50, female only, with Alcohol Abstinence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back.
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | 74.7 | ± 27.4 |
| Placebo (for Guanfacine) | 50.6 | ± 26.5 |
Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back.
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | 15.5 | ± 26.7 |
| Placebo (for Guanfacine) | 30.6 | ± 26.7 |
Urine screening will be conducted twice per week across the trial.
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | 45.3 | ± 35.7 |
| Placebo (for Guanfacine) | 35.2 | ± 19.4 |
The Anxiety subscale of the Profile of Mood States (POMS) was administered to assess anxiety. The subscale comprises 9 adjectives that describe anxiety-related feelings, and participants are required to rate the extent to which they are experiencing each feeling at that moment, from 0= not at all; 1= a little; 2= moderately; 3= quite a bit; 4= extremely. Possible scores range from 0 to 36, with higher scores representing higher levels of anxiety. Anxiety ratings were collected two times per week across twelve weeks (24 time-points). Each time-point represented change from baseline anxiety. The
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -8.2 | ± 8.2 |
| Placebo (for Guanfacine) | -0.75 | ± 4.7 |
The Depression subscale of the Profile of Mood States (POMS) was administered to assess depression. The subscale comprises 15 adjectives that describe depression-related feelings, and participants are required to rate the extent to which they are experiencing each feeling at that moment, from 0= not at all; 1= a little; 2= moderately; 3= quite a bit; 4= extremely. Possible scores range from 0 to 60, with higher scores representing higher levels of depression. Depression ratings were collected two times per week across twelve weeks (24 time-points). Each time-point represented change from basel
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -13.9 | ± 13.3 |
| Placebo (for Guanfacine) | 0.03 | ± 5.2 |
The desire for using alcohol was assessed using a 10-point visual analog scale (VAS) in which 1 = 'not at all' and 10 = 'extremely high'. Alcohol craving ratings were collected two times per week across twelve weeks (24 time-points). Each time-point represented change from baseline alcohol craving. The calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean alcohol craving compared with baseline.
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -1.6 | ± 1.4 |
| Placebo (for Guanfacine) | -1.9 | ± 3.4 |
We used the Impulse Control Difficulties subscale (IMPULSE) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in impulse control across the trial. The DERS was administered two times per week, and the IMPULSE subscale comprised 6 items with a potential score range of 6 to 30 with higher scores representing greater difficulties in impulse control. Each time-point represents change from baseline impulse control difficulties. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in impulse contro
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -2.8 | ± 2.4 |
| Placebo (for Guanfacine) | 0.85 | ± 3.2 |
We used the Difficulties in Engaging in Goal-Directed Behavior (GOALS) subscale of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in goal-directed behavior across the trial. The DERS was administered two times per week (24 time-points) and the GOALS subscale comprised 5 items with a potential score range of 5 to 25 with higher scores representing greater difficulties in engaging in goal-directed behavior. Each time-point represented change from baseline GOALS. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represe
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -3.0 | ± 3.6 |
| Placebo (for Guanfacine) | 0.95 | ± 2.2 |
We used the Lack of Emotional Clarity subscale (CLARITY) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in emotional clarity across the trial. The DERS was administered two times per week, and the CLARITY subscale comprised 5 items with a potential score range of 5 to 25 with higher scores representing greater difficulties in emotional clarity. Each time-point represents change from baseline difficulties in emotional clarity. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in emotiona
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -2.3 | ± 2.8 |
| Placebo (for Guanfacine) | -0.71 | ± 2.3 |
We used the Limited Access to Emotion Regulation Strategies subscale (STRATEGIES) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in ability to access emotion regulation strategies across the trial. The DERS was administered two times per week, and the STRATEGIES subscale comprised 8 items with a potential score range of 8 to 40 with higher scores representing greater difficulties in accessing emotion regulation strategies. Each time-point represents change from baseline STRATEGIES. The calculation here represents mean change from baseline values across the 12 weeks, w
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -5.1 | ± 5.4 |
| Placebo (for Guanfacine) | -0.28 | ± 5.4 |
We used the Lack of Emotional Awareness subscale (AWARENESS) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in emotional awareness across the trial. The DERS was administered two times per week, and the AWARENESS subscale comprised of 6 items with a potential score range of 6 to 30 with higher scores representing greater a greater lack of emotional awareness. Each time-point represents change from baseline emotional awareness. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties in emotion
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -1.6 | ± 4.3 |
| Placebo (for Guanfacine) | -2.9 | ± 5.1 |
We used the Non-Acceptance of Emotional Responses subscale (NON-ACCEPTANCE) of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in non-acceptance of emotional responses across the trial. The DERS was administered two times per week, and the NON-ACCEPTANCE subscale comprised 6 items with a potential score range of 6 to 30 with higher scores representing greater difficulties in acceptance of emotional response. Each time-point represents change from baseline NON-ACCEPTANCE. The calculation here represents mean change from baseline values across the 12 weeks, where minus valu
| Group | Value | 95% CI |
|---|---|---|
| Guanfacine XR 3mgs/Daily | -6.4 | ± 5.7 |
| Placebo (for Guanfacine) | -0.88 | ± 6.6 |
Time frame: 12-weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Guanfacine XR 3mgs/Daily | Placebo (for Guanfacine) |
|---|---|---|---|
| Pelvic Pain | Reproductive system and breast disorders | — | — |
| Reaction | System | Guanfacine XR 3mgs/Daily | Placebo (for Guanfacine) |
|---|---|---|---|
| Headaches | General disorders | — | — |
| Upset Stomach | General disorders | — | — |
| Dry Mouth | General disorders | — | — |
| Dizziness | General disorders | — | — |
| Shakiness | General disorders | — | — |
| Weight Gain | General disorders | — | — |
| Appetite Loss | General disorders | — | — |
| Nightmares | General disorders | — | — |
| Enuresis | General disorders | — | — |
| Itchiness | General disorders | — | — |
| Dehydration | General disorders | — | — |
| Urinary Tract Infection | General disorders | — | — |
Most-reported serious reactions: Pelvic Pain.
Data from ClinicalTrials.gov NCT03137082 adverse events section.
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.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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