Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL



Status:Not yet recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 65
Updated:3/7/2019
Start Date:April 2019
End Date:January 2021
Contact:Jin Ho Yoon, PhD
Email:Jin.Ho.Yoon@uth.tmc.edu
Phone:(713) 486-2858

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Participants (N=10/group) will consist of non-treatment seeking individuals with AUD.

Following informed consent and baseline screening, participants will partake in 3 stress
induction sessions to assess their stress levels and cravings for alcohol. Participants will
be randomized to receive either increasing doses of doxazosin XL (0, 4, and 8 mg) or placebo
in a double-blind manner.


Inclusion Criteria:

- Meet DSM-5 criteria for AUD;

- Report excessive alcohol use as defined by CDC guidelines in the past month (>7
drinks/week for woman, >14 drinks/week for men, >3 drinks/occasion for women>4
drinks/occasion for men)3.

Exclusion Criteria:

- Physical dependence on alcohol assessed using the SCID and Clinical Institute
Withdrawal Assessment for Alcohol (CIWAA)41.

- Presenting an Alcohol Use Disorders Inventory (AUDIT) score indicative of severe
alcohol dependence (≥13 for women, ≥15 for men);

- Meeting criteria for substance use disorder on drugs other than alcohol and nicotine;

- Currently taking a prescribed psychoactive medication (e.g., atomoxetine for ADHD). In
addition, exclusion for those individuals taking CYP3A4 inhibitors. Most participants
will not be taking any concomitant medications (including over-the-counter
supplements). For those who are taking an allowed medication, the study physician will
determine if the medications are CYP3A4 inhibitors.

- Medical conditions contraindicating doxazosin XL pharmacotherapy (e.g., postural
hypotension);

- Taking contraindicated medications such as blood pressure medications;

- Be pregnant, nursing, or planning on becoming pregnant during the course of the study;

- Have any other illness, condition, or use of medications, which in the opinion of the
PI and/or admitting physician would preclude safe and/or successful completion of the
study.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-486-2858
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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