Status:
WITHDRAWN
Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
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 as...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03398252
Start Date
May 12 2022
End Date
October 1 2023
Last Update
September 1 2022
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