# Guanfacine for women with AUD: A multisite study using a telehealth approach

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $731,258

## Abstract

ABSTRACT
There is currently a dearth of FDA-approved medications developed specifically for women with alcohol use
disorder (AUD). This represents a major public health concern for several reasons. First, robust sex- and
gender-related differences set women at a marked disadvantage for progressing to severe AUD more quickly
than men (telescoping). Second, alcohol consumption levels in women have been steadily moving towards
parity with men. Third, women with AUD remain challenging to recruit into research trials, as many have
caregiving commitments and/or feel stigmatized. Together these factors compound the need to develop new
relapse prevention medications tailored to women, using methods that encourage women into clinical trials.
Hence, a 12-week multicenter clinical trial is proposed, using a validated remote platform, which has been
successful at increasing both recruitment and compliance in substance using women. Overarching aims are to
examine whether 3mg/d of guanfacine extended release (GXR) Vs placebo (PBO) can reduce drinking severity
in AUD women by targeting alcohol craving and emotion regulation during stress. Prior research suggests that
these relapse-related processes may represent risk factors particularly pertinent to women and unique to the
pharmacodynamics of guanfacine. N=70 women with AUD will be recruited at the primary site (Stony Brook) and
N=60 at the secondary site (Rutgers) into a 12-week, randomized, double-blind, placebo-controlled clinical trial.
Momentary reports of drinking severity, stress, craving, mood, arousal, anxiety, and emotion regulation will also
be collected throughout the day and evening via three, 2-week bursts of Ecological Momentary Assessment
(EMA), across the 12-week trial (weeks 1 and 2; weeks 5 and 6; and weeks 9 and 10). All data will be collected
using smartphone technology. Participants will also take part in twice weekly remote visits for the entire 12
weeks to assess safety, vitals, collect urines, monitor alcohol use, and receive weekly Medical Management. It
is anticipated that GXR will decrease the number of positive urines across the 12 weeks and the % number of
days spent drinking (H1a, primary outcomes), as well as the mean number of drinks consumed per occasion
and mean number of binge drinking sessions (H1b, secondary outcomes) compared with PBO. It is also
expected that GXR Vs PBO will attenuate momentary ratings of stress-induced drinking and alcohol craving
(H2a), as well as momentary ratings of stress-induced emotion dysregulation, negative mood, arousal, and
anxiety (H2b) such that women taking GXR will have greater decreases in craving and use trajectories over time
(H2c). The efficacy of using a remote platform will additionally be explored by ascertaining attendance,
compliance and medication adherence rates. Findings will help determine the efficacy and underlying
mechanisms of a potentially well-tolerated medication developed specifically for AUD women. The multi-site
desi...

## Key facts

- **NIH application ID:** 10942227
- **Project number:** 1R01AA031662-01
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Helen Cecilia Fox
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $731,258
- **Award type:** 1
- **Project period:** 2024-09-23 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10942227

## Citation

> US National Institutes of Health, RePORTER application 10942227, Guanfacine for women with AUD: A multisite study using a telehealth approach (1R01AA031662-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10942227. Licensed CC0.

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