Alcohol Abstinence
Conditions
Keywords
Alcohol Use Disorder, Guanfacine, Stress, Craving, Gender, Relapse
Brief 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.
Detailed description
Gender-specific variation in sympathetic sensitivity (Fox et al., 2014; Fox and Sinha, 2009; Cahill, 2003; Heinsbroek et al., 1991) may mean that guanfacine is particularly efficacious in attenuating drinking in women, rather than men with Alcohol Use Disorder (AUD). Thus, the investigators propose a double blind, placebo-controlled, 10-week randomized clinical trial to examine the effects of Guanfacine XR (3mgs/daily) versus placebo in 60 women with AUD. This will include twice weekly appointments comprising medical management and contingency management protocols, collection of urine, breathalyzer screens, and vitals. Measures of craving and mood will also be assessed. Parallel laboratory challenge studies will also be conducted both on admission to out-patient treatment and again following 4 weeks of treatment, in order to better elucidate the potentially therapeutic mechanisms of guanfacine. Participants will be exposed to a personal stress versus relaxing imagery condition, 1 condition per day, in a randomized order. Craving, anxiety, mood, cognitive control, heart rate and blood pressure (HRBP), and biological stress system markers will be assessed at baseline, following imagery and at various recovery timepoints.
Interventions
DRUGGuanfacine XR 3mgs/daily
Guanfacine 3mg tablet
DRUGPlacebo (for guanfacine)
Sugar pill manufactured to mimic guanfacine tablets
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days Abstinent | 12 weeks | Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back. |
| Percentage of Heavy Drinking Days | 12 weeks | Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back. |
| Alcohol Consumption (Percentage of Negative Urines) | 12 weeks | Urine screening will be conducted twice per week across the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotion Regulation (Difficulties in Impulse Control) | 12-weeks | 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 control compared with baseline. |
| Emotion Regulation (Difficulties With Engaging in Goal Related Behavior) | 12-week | 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 represent less difficulties in engaging in goal-directed behavior compared with baseline. |
| Emotion Regulation (Difficulties With Emotional Clarity) | 12-weeks | 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 emotional clarity compared with baseline. |
| Mood (Anxiety) | 2 times per week for 12 weeks | 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 calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean anxiety compared with baseline. |
| Emotion Regulation (Difficulties With Emotional Awareness) | 12-weeks | 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 emotional awareness compared with baseline. |
| Emotion Regulation (Non-Acceptance of Emotional Responses) | 12-Week | 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 values represent less difficulties regarding non-acceptance of emotional responses compared with baseline. |
| Emotion Regulation (Total Score) | 12-weeks | We used the Total score of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in overall emotion regulation across the trial. The DERS was administered two times per week, and comprised 41 items with a potential score range of 41 to 164 with higher scores representing greater difficulties in emotion regulation. Each time-point represents change from baseline emotion regulation difficulties. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties regarding emotion regulation compared with baseline. |
| Emotion Regulation (Limited Access to Emotion Regulation Strategies) | 12-weeks | 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, where minus values represent less difficulties in accessing emotion regulation strategies compared with baseline. |
| Mood (Depression) | 2 times per week for 12 weeks | 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 baseline depression. The calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean depression compared with baseline. |
| Alcohol Craving | 12-weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from flyers posted in and around Stony Brook Hospital and its outpatient facilities, in addition to advertisements on social media. The first participant was enrolled in July 2017 and the last in March 2020
Pre-assignment details
Following consent, participants were scheduled for an eligibility intake (including clinical and physical assessments). If eligible, they were scheduled for a second intake which included completing baseline assessments of alcohol and substance use in addition to alcohol craving, mood, anxiety and emotion regulation. Of the 32 women consented, N=17 did not meet criteria and N=15 were eligible and randomized onto study medication.
Participants by arm
| Arm | Count |
|---|---|
| Guanfacine XR 3mgs/Daily * Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet | 8 |
| Placebo (for Guanfacine) * Guanfacine XR tablet by mouth every 24 hours for 12 weeks
* 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
* Full dose: 3mgs/d (day 21- day 70)
* 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Guanfacine XR 3mgs/Daily | Placebo (for Guanfacine) | Total |
|---|---|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 15.8 | 48.3 years STANDARD_DEVIATION 11.1 | 42.6 years STANDARD_DEVIATION 13.5 |
| Depressive Symptomatology | 17.6 units on a scale STANDARD_DEVIATION 12.9 | 11.83 units on a scale STANDARD_DEVIATION 9 | 14.7 units on a scale STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| % no. of binge drinking days in last 3 months | 41.1 % no. of binge drinking days STANDARD_DEVIATION 28.7 | 35.4 % no. of binge drinking days STANDARD_DEVIATION 36.1 | 38.3 % no. of binge drinking days STANDARD_DEVIATION 32.4 |
| % no. of drinking days in last 3 months | 50.1 percentage of days STANDARD_DEVIATION 36 | 66.5 percentage of days STANDARD_DEVIATION 39.1 | 58.3 percentage of days STANDARD_DEVIATION 37.6 |
| no. of drinks consumed per occasion | 4.75 drinks per occasion STANDARD_DEVIATION 1.9 | 4.9 drinks per occasion STANDARD_DEVIATION 4.2 | 4.8 drinks per occasion STANDARD_DEVIATION 2 |
| no. of smokers (tobacco) | 2 participants | 0 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 0 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 2 / 8 | 1 / 7 |
| serious Total, serious adverse events | 1 / 8 | 0 / 7 |
Outcome results
Primary
Alcohol Consumption (Percentage of Negative Urines)
Urine screening will be conducted twice per week across the trial.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Alcohol Consumption (Percentage of Negative Urines) | 45.3 percentage of negative urines | Standard Deviation 35.7 |
| Placebo (for Guanfacine) | Alcohol Consumption (Percentage of Negative Urines) | 35.2 percentage of negative urines | Standard Deviation 19.4 |
Primary
Percentage of Days Abstinent
Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Percentage of Days Abstinent | 74.7 percentage of days abstinent | Standard Deviation 27.4 |
| Placebo (for Guanfacine) | Percentage of Days Abstinent | 50.6 percentage of days abstinent | Standard Deviation 26.5 |
p-value: <0.03Mixed Models Analysis
Primary
Percentage of Heavy Drinking Days
Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Percentage of Heavy Drinking Days | 15.5 percentage heavy drinking days | Standard Deviation 26.7 |
| Placebo (for Guanfacine) | Percentage of Heavy Drinking Days | 30.6 percentage heavy drinking days | Standard Deviation 26.7 |
p-value: 0.1Mixed Models Analysis
Secondary
Alcohol Craving
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.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Alcohol Craving | -1.6 scores on a scale | Standard Deviation 1.4 |
| Placebo (for Guanfacine) | Alcohol Craving | -1.9 scores on a scale | Standard Deviation 3.4 |
p-value: 0.5Mixed Models Analysis
Secondary
Emotion Regulation (Difficulties in Impulse Control)
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 control compared with baseline.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Difficulties in Impulse Control) | -2.8 scores on a scale | Standard Deviation 2.4 |
| Placebo (for Guanfacine) | Emotion Regulation (Difficulties in Impulse Control) | 0.85 scores on a scale | Standard Deviation 3.2 |
p-value: <0.03Mixed Models Analysis
Secondary
Emotion Regulation (Difficulties With Emotional Awareness)
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 emotional awareness compared with baseline.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Difficulties With Emotional Awareness) | -1.6 scores on a scale | Standard Deviation 4.3 |
| Placebo (for Guanfacine) | Emotion Regulation (Difficulties With Emotional Awareness) | -2.9 scores on a scale | Standard Deviation 5.1 |
p-value: 0.4Mixed Models Analysis
Secondary
Emotion Regulation (Difficulties With Emotional Clarity)
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 emotional clarity compared with baseline.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Difficulties With Emotional Clarity) | -2.3 units on a scale | Standard Deviation 2.8 |
| Placebo (for Guanfacine) | Emotion Regulation (Difficulties With Emotional Clarity) | -0.71 units on a scale | Standard Deviation 2.3 |
p-value: <0.3Mixed Models Analysis
Secondary
Emotion Regulation (Difficulties With Engaging in Goal Related Behavior)
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 represent less difficulties in engaging in goal-directed behavior compared with baseline.
Time frame: 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Difficulties With Engaging in Goal Related Behavior) | -3.0 scores on a scale | Standard Deviation 3.6 |
| Placebo (for Guanfacine) | Emotion Regulation (Difficulties With Engaging in Goal Related Behavior) | 0.95 scores on a scale | Standard Deviation 2.2 |
p-value: 0.1Mixed Models Analysis
Secondary
Emotion Regulation (Limited Access to Emotion Regulation Strategies)
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, where minus values represent less difficulties in accessing emotion regulation strategies compared with baseline.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Limited Access to Emotion Regulation Strategies) | -5.1 scores on a scale | Standard Deviation 5.4 |
| Placebo (for Guanfacine) | Emotion Regulation (Limited Access to Emotion Regulation Strategies) | -0.28 scores on a scale | Standard Deviation 5.4 |
p-value: 0.04Mixed Models Analysis
Secondary
Emotion Regulation (Non-Acceptance of Emotional Responses)
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 values represent less difficulties regarding non-acceptance of emotional responses compared with baseline.
Time frame: 12-Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Non-Acceptance of Emotional Responses) | -6.4 scores on a scale | Standard Deviation 5.7 |
| Placebo (for Guanfacine) | Emotion Regulation (Non-Acceptance of Emotional Responses) | -0.88 scores on a scale | Standard Deviation 6.6 |
p-value: 0.08Mixed Models Analysis
Secondary
Emotion Regulation (Total Score)
We used the Total score of the Difficulties in Emotion Regulation Scale (DERS) to assess changes in overall emotion regulation across the trial. The DERS was administered two times per week, and comprised 41 items with a potential score range of 41 to 164 with higher scores representing greater difficulties in emotion regulation. Each time-point represents change from baseline emotion regulation difficulties. The calculation here represents mean change from baseline values across the 12 weeks, where minus values represent less difficulties regarding emotion regulation compared with baseline.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Emotion Regulation (Total Score) | -19.8 scores on a scale | Standard Deviation 17.3 |
| Placebo (for Guanfacine) | Emotion Regulation (Total Score) | -4.5 scores on a scale | Standard Deviation 21.3 |
p-value: 0.2Mixed Models Analysis
Secondary
Mood (Anxiety)
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 calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean anxiety compared with baseline.
Time frame: 2 times per week for 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Mood (Anxiety) | -8.2 scores on a scale | Standard Deviation 8.2 |
| Placebo (for Guanfacine) | Mood (Anxiety) | -0.75 scores on a scale | Standard Deviation 4.7 |
p-value: 0.01Mixed Models Analysis
Secondary
Mood (Depression)
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 baseline depression. The calculation here represents mean change from baseline values across the 12 weeks, where minus scores represent lower mean depression compared with baseline.
Time frame: 2 times per week for 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine XR 3mgs/Daily | Mood (Depression) | -13.9 scores on a scale | Standard Deviation 13.3 |
| Placebo (for Guanfacine) | Mood (Depression) | 0.03 scores on a scale | Standard Deviation 5.2 |
p-value: 0.001Mixed Models Analysis