Health TrialsbyHealthPanel

Alpha-1 Blockade for Alcohol Use Disorder (AUD)

ConditionAlcohol Use Disorder (AUD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University

About this trial

The goal of this research is to replicate findings previously conducted in a pilot trial and to understand, mechanistically, the role of stress in the development of AUD pharmacotherapies that target noradrenergic blockade.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18 years of age

Meet the DSM-5 criteria for AUD

Desire to reduce or quit alcohol drinking

Breath alcohol (BrAC) = 0.00 at each visit

Disqualifiers

Women who are breastfeeding or /positive urine test for pregnancy

CrCl<60mL/min

Suicide attempt in the last three months

Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxazosin

    Drug

    16 mg or maximum tolerated dose (MTD)

  • Placebo

    Drug

    Matching placebo

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: doxazosinExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Alcohol consumption

Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)

Time frame
6 weeks

Secondary outcomes

1

Alcohol craving

We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity

Time frame
one day
2

Alcohol craving

Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)

Time frame
six weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

Source ClinicalTrials.gov
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