A Phase 1 interventional study of Doxazosin XL and Placebo in Alcohol Use Disorder, sponsored by The University of Texas Health Science Center, Houston. Withdrawn. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by The University of Texas Health Science Center, Houston · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
Participants will receive increasing doses of doxazosin XL (0, 4, and 8 mg).
Drug: Doxazosin XL
Participants will be randomized to receive a placebo for doxazosin XL.
Drug: Placebo
Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).
Also known as: Cardura XL, Cardura
Participants will be randomized to receive a placebo for doxazosin XL.
Feasibility as study attendance
Attending sessions
Time frame: Two weeks
Stress as assessed by salivary cortisol levels
Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
Time frame: baseline
Stress as assessed by salivary cortisol levels
Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
Time frame: Friday of week 1
Stress as assessed by salivary cortisol levels
Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
Time frame: Friday of week 2
Stress as assessed by self-report
Self-reported stress on a questionnaire
Time frame: baseline
Stress as assessed by self-report
Self-reported stress on a questionnaire
Time frame: Friday of week 1
Stress as assessed by self-report
Self-reported stress on a questionnaire
Time frame: Friday of week 2
Stress as assessed by heart rate
Self-reported stress on a questionnaire
Time frame: baseline
Stress as assessed by heart rate
Self-reported stress on a questionnaire
Time frame: Friday of week 1
Stress as assessed by heart rate
Self-reported stress on a questionnaire
Time frame: Friday of week 2
stress reactivity as assessed by increased blood pressure
Blood pressure
Time frame: baseline
stress reactivity as assessed by increased blood pressure
Blood pressure
Time frame: Friday of week 1
stress reactivity as assessed by increased blood pressure
Blood pressure
Time frame: Friday of week 2
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.
Time frame: baseline
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.
Time frame: Friday of week 1
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.
Time frame: Friday of week 2
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?").
Time frame: baseline
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?").
Time frame: Friday of week 1
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?").
Time frame: Friday of week 2
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.
Time frame: baseline
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.
Time frame: Friday of week 1
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.
Time frame: Friday of week 2
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.
Time frame: baseline
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.
Time frame: Friday of week 1
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.
Time frame: Friday of week 2
Alcohol use as assessed by self-report
Self-reported drinks per day for the past week
Time frame: baseline
Alcohol use as assessed by self-report
Self-reported drinks per day for the past week
Time frame: Friday of week 1
Alcohol use as assessed by self-report
Self-reported drinks per day for the past week
Time frame: Friday of week 2
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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The University of Texas Health Science Center, Houston