Alcohol Use Disorder
Conditions
Keywords
Alcohol Use Disorder, Stress, Guanfacine, Sex Differences
Brief summary
The investigators assess whether guanfacine extended release (GXR; 3mg/d) compared with placebo (PBO) will attenuate drinking and drinking-related factors in N=200 men and women with Alcohol Use Disorder (AUD) across 12-weeks.
Detailed description
This is a study to examine the efficacy of guanfacine extended release (GXR) (3mg/d) compared with placebo (PBO) in reducing drinking in N=200 men and women with Alcohol Use Disorder (AUD). The study will be conducted across two sites for 12-weeks. Indiana University will be the primary site and Rutgers University, the secondary site. Participants at both sites will be randomized to either GXR (3mg/d) or placebo (PBO), and titrated to full dose over a three week period. After remaining at full dose for 7 weeks a two week schedule will be used to taper participants off the medication. During the study the investigators will collect brief reports throughout the day and evening of drinking severity, stress, craving, mood, arousal, anxiety, and emotion regulation at weeks 1 and 2 (baseline) and weeks 5 and 6 (steady state). Additionally, blood alcohol concentration (BAC) levels will be collected three times per day for the full 12-weeks. Daily encrypted video recordings will be used to monitor medication compliance, and participants will also take part in twice weekly remote visits to assess safety, vitals, collect urines, monitor alcohol use, and receive weekly Medical Management. It is anticipated that guanfacine will demonstrate greater efficacy in women compared to men with AUD.
Interventions
DRUGGuanfacine Extended Release (XR)
3mg tablet once daily
DRUGPlacebo
placebo tablet once daily
Sponsors
Indiana University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Intervention model description
randomized double blind, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be assigned as a biological male or female at birth and identify as such * meet current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) criteria for moderate to severe AUD * be ≥18 years old and have a body mass index (BMI) of 18-35 * express a desire to quit alcohol as determined by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) * demonstrate a positive urine for alcohol on admission to study procedures * be able to provide informed verbal and written consent * be able to read English and complete study evaluations * be in good health as verified by the intake 1 physical examination
Exclusion criteria
* meet criteria for moderate to severe Substance Use Disorder (SUD), excluding alcohol and nicotine * have a positive screen for substances of abuse, excluding alcohol, nicotine, * being psychotic or otherwise severely psychiatrically disabled (including suicidal, homicidal, current mania) * meet criteria for physiological dependence on alcohol requiring medical detoxification * regular use of medications in the last 6 months that, in the opinion of the site physician may be contraindicated with GXR and be potentially harmful to the participant * be pregnant or breast feeding * be using monophasic contraceptives * have cardiovascular disease including high blood pressure, * be hypotensive with sitting blood pressure below 100/50 mmHG * have bradycardia with a sitting heart rate (HR) of \<60 bpm * show EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \>470 msec for women and QTc\>450 msec for men.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in % number of days drinking | five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12 | Self-reports of alcohol use |
| Change in Blood Alcohol Concentration (BAC) levels | three times per day through week 12. | BAC levels will be collected using a remote breathalyzer application called BACtrack |
| Change in no. of drinks consumed following stress | five times daily during weeks 1, 2, 5, 6 | Self reports of alcohol use will be collected following stress, which will be measured using a visual analog scale (VAS) anchored from 0 (not stressed at all) to 100 (extremely stressed). |
| Change in alcohol craving following stress | five times daily during weeks 1, 2, 5, 6 | Self-reports of alcohol craving will be collected using a VAS anchored from 0 (Not craving at all) to 100 (Craving extremely) following self-reported stress. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of drinks consumed per occasion | five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12 | Self-reports of alcohol use |
| Change in number of binge episodes | five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12 | Self-reports of alcohol use |
| Change in negative mood following stress | five times daily during weeks 1, 2, 5, 6 | Self-reports of negative mood will be collected using The Positive and Negative Affect Schedule (PANAS) following self-reported stress (visual analog scale; VAS). The PANAS is scored from 10-50, with a higher score representing greater negative mood. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed). |
| Change in anxiety following stress | five times daily during weeks 1, 2, 5, 6 | Self-reports of anxiety will be collected using The Positive and Negative Affect Schedule (PANAS) following self-reported stress (visual analog scale; VAS). The PANAS is scored from 10-50, with a higher score representing greater anxiety. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed). |
| Change in arousal following stress | five times daily during weeks 1, 2, 5, 6 | Self-reports of arousal will be collected using The Positive and Negative Affect Schedule (PANAS) following self-reported stress (visual analog scale; VAS). The PANAS is scored from 10-50, with a higher score representing greater arousal. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed). |
| Change in emotion regulation following stress | five times daily during weeks 1, 2, 5, 6 | Self-reports of emotion regulation will be collected using The Difficulties in Emotion Regulation Scale (DERS) developed for ecological momentary assessment (EMA) following self-reported stress (visual analog scale; VAS). The DERS is scored from 36-180 across all items, with a higher score representing greater difficulties in regulating emotion. The VAS for stress will be anchored from 0 (not stressed at all) to 100 (extremely stressed). |
Countries
United States
Contacts
CONTACTHelen C Fox, PhD
CONTACTMitch Smith
PRINCIPAL_INVESTIGATORHelen C Fox, PhD
Associate Professor
Outcome results
None listed