Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

NCT03398252 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: HSC-MS-17-0678
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Feasibility as study attendance

  Attending sessions

  Two weeks

Secondary Outcomes (27)

• Stress as assessed by salivary cortisol levels

  baseline

• Stress as assessed by salivary cortisol levels

  Friday of week 1

• Stress as assessed by salivary cortisol levels

  Friday of week 2

• Stress as assessed by self-report

  baseline

• Stress as assessed by self-report

  Friday of week 1

Study Arms (2)

Doxazosin XL

EXPERIMENTAL

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

Drug: Doxazosin XL

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Doxazosin XL DRUG

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

Also known as: Cardura XL, Cardura

Doxazosin XL

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

MeSH Terms

Conditions

Alcoholism

Interventions

Doxazosin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jin Ho Yoon, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: January 12, 2018
• Study Start: May 12, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08