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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
3mg tablet once daily
placebo tablet once daily
The Stark Neuroscience Building (Goodman Hall)
Indianapolis, Indiana, United States
RECRUITINGRutgers School of Health Professionals
Newark, New Jersey, United States
RECRUITINGChange in % number of days drinking
Self-reports of alcohol use
Time frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
Change in Blood Alcohol Concentration (BAC) levels
BAC levels will be collected using a remote breathalyzer application called BACtrack
Time frame: three times per day through week 12.
Change in no. of drinks consumed following stress
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).
Time frame: five times daily during weeks 1, 2, 5, 6
Change in alcohol craving following stress
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).
Time frame: five times daily during weeks 1, 2, 5, 6
Change in number of drinks consumed per occasion
Self-reports of alcohol use
Time frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
Change in number of binge episodes
Self-reports of alcohol use
Time frame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
Change in negative mood following stress
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).
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Time frame: five times daily during weeks 1, 2, 5, 6
Change in anxiety following stress
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).
Time frame: five times daily during weeks 1, 2, 5, 6
Change in arousal following stress
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).
Time frame: five times daily during weeks 1, 2, 5, 6
Change in emotion regulation following stress
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).
Time frame: five times daily during weeks 1, 2, 5, 6