Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
- Registration Number
- NCT03398252
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doxazosin XL Doxazosin XL Participants will receive increasing doses of doxazosin XL (0, 4, and 8 mg). Placebo Placebo Participants will be randomized to receive a placebo for doxazosin XL.
- Primary Outcome Measures
Name Time Method Feasibility as study attendance Two weeks Attending sessions
- Secondary Outcome Measures
Name Time Method Stress as assessed by salivary cortisol levels Friday of week 2 Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
stress reactivity as assessed by increased blood pressure Friday of week 2 Blood pressure
Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS) Friday of week 2 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 Friday of week 2 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?").
Stress as assessed by self-report Friday of week 2 Self-reported stress on a questionnaire
Stress as assessed by heart rate Friday of week 2 Self-reported stress on a questionnaire
Delay discounting for alcohol as assessed by a computerized task Friday of week 2 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 Friday of week 2 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 Friday of week 2 Self-reported drinks per day for the past week