Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

Alcohol Use Disorder Clinical Trial

Official title:

Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03398252
• Other study ID #: HSC-MS-17-0678
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 12, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Doxazosin XL
Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).
• Placebo
Participants will be randomized to receive a placebo for doxazosin XL.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as study attendance	Attending sessions	Two weeks
Secondary	Stress as assessed by salivary cortisol levels	Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).	baseline
Secondary	Stress as assessed by salivary cortisol levels	Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).	Friday of week 1
Secondary	Stress as assessed by salivary cortisol levels	Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).	Friday of week 2
Secondary	Stress as assessed by self-report	Self-reported stress on a questionnaire	baseline
Secondary	Stress as assessed by self-report	Self-reported stress on a questionnaire	Friday of week 1
Secondary	Stress as assessed by self-report	Self-reported stress on a questionnaire	Friday of week 2
Secondary	Stress as assessed by heart rate	Self-reported stress on a questionnaire	baseline
Secondary	Stress as assessed by heart rate	Self-reported stress on a questionnaire	Friday of week 1
Secondary	Stress as assessed by heart rate	Self-reported stress on a questionnaire	Friday of week 2
Secondary	stress reactivity as assessed by increased blood pressure	Blood pressure	baseline
Secondary	stress reactivity as assessed by increased blood pressure	Blood pressure	Friday of week 1
Secondary	stress reactivity as assessed by increased blood pressure	Blood pressure	Friday of week 2
Secondary	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.	baseline
Secondary	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.	Friday of week 1
Secondary	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.	Friday of week 2
Secondary	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?").	baseline
Secondary	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?").	Friday of week 1
Secondary	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?").	Friday of week 2
Secondary	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.	baseline
Secondary	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.	Friday of week 1
Secondary	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.	Friday of week 2
Secondary	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.	baseline
Secondary	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.	Friday of week 1
Secondary	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.	Friday of week 2
Secondary	Alcohol use as assessed by self-report	Self-reported drinks per day for the past week	baseline
Secondary	Alcohol use as assessed by self-report	Self-reported drinks per day for the past week	Friday of week 1
Secondary	Alcohol use as assessed by self-report	Self-reported drinks per day for the past week	Friday of week 2