Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

NCT ID: NCT03398252

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2023-10-01

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 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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Doxazosin XL

Participants will receive increasing doses of doxazosin XL (0, 4, and 8 mg).

Group Type: EXPERIMENTAL

Doxazosin XL

Intervention Type: DRUG

Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).

Placebo

Participants will be randomized to receive a placebo for doxazosin XL.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will be randomized to receive a placebo for doxazosin XL.

Interventions

Doxazosin XL

Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).

Intervention Type: DRUG

Placebo

Participants will be randomized to receive a placebo for doxazosin XL.

Intervention Type: DRUG

Other Intervention Names

Cardura XL; Cardura

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Jin Ho Yoon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Ho Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Other Identifiers

HSC-MS-17-0678

Identifier Type: -

Identifier Source: org_study_id