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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanfacine XR 3mgs/daily | Experimental |
|
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| Placebo (for guanfacine) | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanfacine XR 3mgs/daily | Drug | Guanfacine 3mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days Abstinent | Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back. | 12 weeks |
| Percentage of Heavy Drinking Days | Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back. | 12 weeks |
| Alcohol Consumption (Percentage of Negative Urines) | Urine screening will be conducted twice per week across the trial. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen C Fox, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Health Sciences Center | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24395021 | Background | Fox HC, Morgan PT, Sinha R. Sex differences in guanfacine effects on drug craving and stress arousal in cocaine-dependent individuals. Neuropsychopharmacology. 2014 May;39(6):1527-37. doi: 10.1038/npp.2014.1. Epub 2014 Jan 7. | |
| 19373619 | Background | Fox HC, Sinha R. Sex differences in drug-related stress-system changes: implications for treatment in substance-abusing women. Harv Rev Psychiatry. 2009;17(2):103-19. doi: 10.1080/10673220902899680. |
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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 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
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| ID | Title | Description |
|---|---|---|
| FG000 | Guanfacine XR 3mgs/Daily |
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet |
| FG001 | Placebo (for Guanfacine) |
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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32 women were enrolled in the study. N=17 were not eligible, N=15 were randomized to study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Guanfacine XR 3mgs/Daily |
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Days Abstinent | Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back. | Posted | Mean | Standard Deviation | percentage of days abstinent | 12 weeks |
|
12-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guanfacine XR 3mgs/Daily |
Guanfacine XR 3mgs/daily: Guanfacine 3mg tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment | participant admitted to ED and diagnosed with ovarian cysts |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | General disorders | Systematic Assessment |
Delay in study commencement and staff losses leading to small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Helen C Fox | Stony Brook University | 631 632 0057 | helen.fox@stonybrookmedicine.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2020 | Nov 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064829 | Alcohol Abstinence |
| D000437 | Alcoholism |
| D003075 | Coitus |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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| Placebo (for guanfacine) | Drug | Sugar pill manufactured to mimic guanfacine tablets |
|
|
| 2 times per week for 12 weeks |
| 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. | 2 times per week for 12 weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-week |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-Week |
| 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. | 12-weeks |
| 1913155 | Background | Heinsbroek RP, van Haaren F, Feenstra MG, Boon P, van de Poll NE. Controllable and uncontrollable footshock and monoaminergic activity in the frontal cortex of male and female rats. Brain Res. 1991 Jun 14;551(1-2):247-55. doi: 10.1016/0006-8993(91)90939-s. |
| 12724157 | Background | Cahill L. Sex-related influences on the neurobiology of emotionally influenced memory. Ann N Y Acad Sci. 2003 Apr;985:163-73. doi: 10.1111/j.1749-6632.2003.tb07080.x. |
| 36001426 | Derived | Konjusha A, Colzato L, Ghin F, Stock AK, Beste C. Auricular transcutaneous vagus nerve stimulation for alcohol use disorder: A chance to improve treatment? Addict Biol. 2022 Sep;27(5):e13202. doi: 10.1111/adb.13202. |
| Placebo (for Guanfacine) |
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| % no. of drinking days in last 3 months | Mean | Standard Deviation | percentage of days |
|
| no. of drinks consumed per occasion | Mean | Standard Deviation | drinks per occasion |
|
| % no. of binge drinking days in last 3 months | Mean | Standard Deviation | % no. of binge drinking days |
|
| Depressive Symptomatology | Depressive symptomatology was measured using the Beck Depression Inventory (BDI). Possible scores range from 0 to 63, with scores of > 40 reflecting "extreme depression". Baseline scores were collected at one time-point. | Mean | Standard Deviation | units on a scale |
|
| no. of smokers (tobacco) | Number | participants |
|
|
|
|
| Primary | Percentage of Heavy Drinking Days | Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back. | Posted | Mean | Standard Deviation | percentage heavy drinking days | 12 weeks |
|
|
|
|
| Primary | Alcohol Consumption (Percentage of Negative Urines) | Urine screening will be conducted twice per week across the trial. | Posted | Mean | Standard Deviation | percentage of negative urines | 12 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 2 times per week for 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 2 times per week for 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-week |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12-weeks |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
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|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-Week |
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
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|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 2 |
| 8 |
| EG001 | Placebo (for Guanfacine) |
Placebo (for guanfacine): Sugar pill manufactured to mimic guanfacine tablets | 0 | 7 | 0 | 7 | 1 | 7 |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Upset Stomach | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Shakiness | General disorders | Systematic Assessment |
|
| Weight Gain | General disorders | Systematic Assessment |
|
| Appetite Loss | General disorders | Systematic Assessment |
|
| Nightmares | General disorders | Systematic Assessment |
|
| Enuresis | General disorders | Systematic Assessment |
|
| Itchiness | General disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | General disorders | Systematic Assessment |
|
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002241 | Carbohydrates |