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Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

Primary Purpose

Alcohol Use Disorder

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Doxazosin XL
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Doxazosin XL

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Feasibility as study attendance
    Attending sessions

    Secondary Outcome Measures

    Stress as assessed by salivary cortisol levels
    Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
    Stress as assessed by salivary cortisol levels
    Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
    Stress as assessed by salivary cortisol levels
    Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
    Stress as assessed by self-report
    Self-reported stress on a questionnaire
    Stress as assessed by self-report
    Self-reported stress on a questionnaire
    Stress as assessed by self-report
    Self-reported stress on a questionnaire
    Stress as assessed by heart rate
    Self-reported stress on a questionnaire
    Stress as assessed by heart rate
    Self-reported stress on a questionnaire
    Stress as assessed by heart rate
    Self-reported stress on a questionnaire
    stress reactivity as assessed by increased blood pressure
    Blood pressure
    stress reactivity as assessed by increased blood pressure
    Blood pressure
    stress reactivity as assessed by increased blood pressure
    Blood pressure
    Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
    The Penn Alcohol Craving Scale (PACS) is a 5 question self-report measure that assesses alcohol craving in the past week. Each question ranges from 0 (no craving) to 6 (highest craving). The total score on the scale ranges from 0 to 30, and higher scores indicate greater alcohol craving.
    Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
    The Penn Alcohol Craving Scale (PACS) is a 5 question self-report measure that assesses alcohol craving in the past week. Each question ranges from 0 (no craving) to 6 (highest craving). The total score on the scale ranges from 0 to 30, and higher scores indicate greater alcohol craving.
    Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
    The Penn Alcohol Craving Scale (PACS) is a 5 question self-report measure that assesses alcohol craving in the past week. Each question ranges from 0 (no craving) to 6 (highest craving). The total score on the scale ranges from 0 to 30, and higher scores indicate greater alcohol craving.
    Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
    Alcohol demand will be assessed via the Brief Assessment of Alcohol Demand (BAAD), a 3-item questionnaire ("If drinks were free, how many would have?", "What is the maximum total amount you would spend on drinking?"; and "What is the maximum you would pay for a single drink?").
    Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
    Alcohol demand will be assessed via the Brief Assessment of Alcohol Demand (BAAD), a 3-item questionnaire ("If drinks were free, how many would have?", "What is the maximum total amount you would spend on drinking?"; and "What is the maximum you would pay for a single drink?").
    Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
    Alcohol demand will be assessed via the Brief Assessment of Alcohol Demand (BAAD), a 3-item questionnaire ("If drinks were free, how many would have?", "What is the maximum total amount you would spend on drinking?"; and "What is the maximum you would pay for a single drink?").
    Delay discounting for alcohol as assessed by a computerized task
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000. In the case of alcohol discounting, the unit of alcohol (e.g., bottle, shot, glass, etc.) and cost of alcohol will be individually assessed in order to present choices that are monetarily equivalent to the money discounting task.
    Delay discounting for alcohol as assessed by a computerized task
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000. In the case of alcohol discounting, the unit of alcohol (e.g., bottle, shot, glass, etc.) and cost of alcohol will be individually assessed in order to present choices that are monetarily equivalent to the money discounting task.
    Delay discounting for alcohol as assessed by a computerized task
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000. In the case of alcohol delay discounting, the unit of alcohol (e.g., bottle, shot, glass, etc.) and cost of alcohol will be individually assessed in order to present choices that are monetarily equivalent to the money discounting task.
    Delay Discounting for money as assessed by a computerized task
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000.
    Delay Discounting for money as assessed by a computerized task
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000.
    Delay Discounting for money as assessed by a computerized task
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000.
    Alcohol use as assessed by self-report
    Self-reported drinks per day for the past week
    Alcohol use as assessed by self-report
    Self-reported drinks per day for the past week
    Alcohol use as assessed by self-report
    Self-reported drinks per day for the past week

    Full Information

    First Posted
    November 6, 2017
    Last Updated
    August 29, 2022
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03398252
    Brief Title
    Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
    Official Title
    Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No funding
    Study Start Date
    May 12, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Doxazosin XL
    Arm Type
    Experimental
    Arm Description
    Participants will receive increasing doses of doxazosin XL (0, 4, and 8 mg).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be randomized to receive a placebo for doxazosin XL.
    Intervention Type
    Drug
    Intervention Name(s)
    Doxazosin XL
    Other Intervention Name(s)
    Cardura XL, Cardura
    Intervention Description
    Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants will be randomized to receive a placebo for doxazosin XL.
    Primary Outcome Measure Information:
    Title
    Feasibility as study attendance
    Description
    Attending sessions
    Time Frame
    Two weeks
    Secondary Outcome Measure Information:
    Title
    Stress as assessed by salivary cortisol levels
    Description
    Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
    Time Frame
    baseline
    Title
    Stress as assessed by salivary cortisol levels
    Description
    Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
    Time Frame
    Friday of week 1
    Title
    Stress as assessed by salivary cortisol levels
    Description
    Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
    Time Frame
    Friday of week 2
    Title
    Stress as assessed by self-report
    Description
    Self-reported stress on a questionnaire
    Time Frame
    baseline
    Title
    Stress as assessed by self-report
    Description
    Self-reported stress on a questionnaire
    Time Frame
    Friday of week 1
    Title
    Stress as assessed by self-report
    Description
    Self-reported stress on a questionnaire
    Time Frame
    Friday of week 2
    Title
    Stress as assessed by heart rate
    Description
    Self-reported stress on a questionnaire
    Time Frame
    baseline
    Title
    Stress as assessed by heart rate
    Description
    Self-reported stress on a questionnaire
    Time Frame
    Friday of week 1
    Title
    Stress as assessed by heart rate
    Description
    Self-reported stress on a questionnaire
    Time Frame
    Friday of week 2
    Title
    stress reactivity as assessed by increased blood pressure
    Description
    Blood pressure
    Time Frame
    baseline
    Title
    stress reactivity as assessed by increased blood pressure
    Description
    Blood pressure
    Time Frame
    Friday of week 1
    Title
    stress reactivity as assessed by increased blood pressure
    Description
    Blood pressure
    Time Frame
    Friday of week 2
    Title
    Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
    Description
    The Penn Alcohol Craving Scale (PACS) is a 5 question self-report measure that assesses alcohol craving in the past week. Each question ranges from 0 (no craving) to 6 (highest craving). The total score on the scale ranges from 0 to 30, and higher scores indicate greater alcohol craving.
    Time Frame
    baseline
    Title
    Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
    Description
    The Penn Alcohol Craving Scale (PACS) is a 5 question self-report measure that assesses alcohol craving in the past week. Each question ranges from 0 (no craving) to 6 (highest craving). The total score on the scale ranges from 0 to 30, and higher scores indicate greater alcohol craving.
    Time Frame
    Friday of week 1
    Title
    Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
    Description
    The Penn Alcohol Craving Scale (PACS) is a 5 question self-report measure that assesses alcohol craving in the past week. Each question ranges from 0 (no craving) to 6 (highest craving). The total score on the scale ranges from 0 to 30, and higher scores indicate greater alcohol craving.
    Time Frame
    Friday of week 2
    Title
    Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
    Description
    Alcohol demand will be assessed via the Brief Assessment of Alcohol Demand (BAAD), a 3-item questionnaire ("If drinks were free, how many would have?", "What is the maximum total amount you would spend on drinking?"; and "What is the maximum you would pay for a single drink?").
    Time Frame
    baseline
    Title
    Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
    Description
    Alcohol demand will be assessed via the Brief Assessment of Alcohol Demand (BAAD), a 3-item questionnaire ("If drinks were free, how many would have?", "What is the maximum total amount you would spend on drinking?"; and "What is the maximum you would pay for a single drink?").
    Time Frame
    Friday of week 1
    Title
    Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
    Description
    Alcohol demand will be assessed via the Brief Assessment of Alcohol Demand (BAAD), a 3-item questionnaire ("If drinks were free, how many would have?", "What is the maximum total amount you would spend on drinking?"; and "What is the maximum you would pay for a single drink?").
    Time Frame
    Friday of week 2
    Title
    Delay discounting for alcohol as assessed by a computerized task
    Description
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000. In the case of alcohol discounting, the unit of alcohol (e.g., bottle, shot, glass, etc.) and cost of alcohol will be individually assessed in order to present choices that are monetarily equivalent to the money discounting task.
    Time Frame
    baseline
    Title
    Delay discounting for alcohol as assessed by a computerized task
    Description
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000. In the case of alcohol discounting, the unit of alcohol (e.g., bottle, shot, glass, etc.) and cost of alcohol will be individually assessed in order to present choices that are monetarily equivalent to the money discounting task.
    Time Frame
    Friday of week 1
    Title
    Delay discounting for alcohol as assessed by a computerized task
    Description
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000. In the case of alcohol delay discounting, the unit of alcohol (e.g., bottle, shot, glass, etc.) and cost of alcohol will be individually assessed in order to present choices that are monetarily equivalent to the money discounting task.
    Time Frame
    Friday of week 2
    Title
    Delay Discounting for money as assessed by a computerized task
    Description
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000.
    Time Frame
    baseline
    Title
    Delay Discounting for money as assessed by a computerized task
    Description
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000.
    Time Frame
    Friday of week 1
    Title
    Delay Discounting for money as assessed by a computerized task
    Description
    Delay discounting will be assessed for both money and alcohol using a computerized task at weekly clinic visits. Delays will range from 1 day to 25 years, and monetary values will range from $0 to $1,000.
    Time Frame
    Friday of week 2
    Title
    Alcohol use as assessed by self-report
    Description
    Self-reported drinks per day for the past week
    Time Frame
    baseline
    Title
    Alcohol use as assessed by self-report
    Description
    Self-reported drinks per day for the past week
    Time Frame
    Friday of week 1
    Title
    Alcohol use as assessed by self-report
    Description
    Self-reported drinks per day for the past week
    Time Frame
    Friday of week 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jin Ho Yoon, PhD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

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