Clinical trial NCT03398252: Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
Official title: Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Feasibility as study attendance
timeFrame: Two weeks
Secondary outcomes:
measure: Stress as assessed by salivary cortisol levels
timeFrame: baseline
measure: Stress as assessed by salivary cortisol levels
timeFrame: Friday of week 1
measure: Stress as assessed by salivary cortisol levels
timeFrame: Friday of week 2
measure: Stress as assessed by self-report
timeFrame: baseline
measure: Stress as assessed by self-report
timeFrame: Friday of week 1
measure: Stress as assessed by self-report
timeFrame: Friday of week 2
measure: Stress as assessed by heart rate
timeFrame: baseline
measure: Stress as assessed by heart rate
timeFrame: Friday of week 1
measure: Stress as assessed by heart rate
timeFrame: Friday of week 2
measure: stress reactivity as assessed by increased blood pressure
timeFrame: baseline
measure: stress reactivity as assessed by increased blood pressure
timeFrame: Friday of week 1
measure: stress reactivity as assessed by increased blood pressure
timeFrame: Friday of week 2
measure: Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
timeFrame: baseline
measure: Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
timeFrame: Friday of week 1
measure: Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
timeFrame: Friday of week 2
measure: Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
timeFrame: baseline
measure: Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
timeFrame: Friday of week 1
measure: Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
timeFrame: Friday of week 2
measure: Delay discounting for alcohol as assessed by a computerized task
timeFrame: baseline
measure: Delay discounting for alcohol as assessed by a computerized task
timeFrame: Friday of week 1
measure: Delay discounting for alcohol as assessed by a computerized task
timeFrame: Friday of week 2
measure: Delay Discounting for money as assessed by a computerized task
timeFrame: baseline
measure: Delay Discounting for money as assessed by a computerized task
timeFrame: Friday of week 1
measure: Delay Discounting for money as assessed by a computerized task
timeFrame: Friday of week 2
measure: Alcohol use as assessed by self-report
timeFrame: baseline
measure: Alcohol use as assessed by self-report
timeFrame: Friday of week 1
measure: Alcohol use as assessed by self-report
timeFrame: Friday of week 2
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jin Ho Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: