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Withdrawn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
About this trial
This is an interventional other trial for Alcohol Use Disorder
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.
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
NCT ID
NCT03398252
First Posted
November 6, 2017
Last Updated
August 29, 2022
Sponsor
The University of Texas Health Science Center, Houston
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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