Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

The University of Texas System (UT)

Status and phase

Withdrawn

Phase 1

Conditions

Alcohol Use Disorder

Treatments

Drug: Doxazosin XL

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03398252

HSC-MS-17-0678

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.