Alcohol Use Disorder
Conditions
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.
Interventions
DRUGDoxazosin XL
Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).
DRUGPlacebo
Participants will be randomized to receive a placebo for doxazosin XL.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as study attendance | Two weeks | Attending sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress as assessed by self-report | baseline | Self-reported stress on a questionnaire |
| Stress as assessed by heart rate | baseline | Self-reported stress on a questionnaire |
| stress reactivity as assessed by increased blood pressure | baseline | Blood pressure |
| Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS) | baseline | 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. |
| Stress as assessed by salivary cortisol levels | baseline | Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences). |
| Delay discounting for alcohol as assessed by a computerized task | baseline | 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 money as assessed by a computerized task | baseline | 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 | baseline | Self-reported drinks per day for the past week |
| Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire | baseline | 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?). |
Outcome results
None listed