Alcohol Use DisorderPhase 1NCT03398252
Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
A Phase 1 study testing Doxazosin XL in people with Alcohol Use Disorder, run by The University of Texas Health Science Center, Houston.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Doxazosin XL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2022to 1 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Doxazosin XL, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin XLDrug
Also called Cardura XL, Cardura
Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).
PlaceboDrug
Participants will be randomized to receive a placebo for doxazosin XL.
| Study group | Role | What they receive |
|---|---|---|
| Doxazosin XL | Experimental | Participants will receive increasing doses of doxazosin XL (0, 4, and 8 mg). Receives: Drug: Doxazosin XL |
| Placebo | Placebo comparator | Participants will be randomized to receive a placebo for doxazosin XL. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as study attendance
Attending sessions
Measured: Two weeks
Secondary outcomes (27)
Stress as assessed by salivary cortisol levels
Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
Measured: baseline
Stress as assessed by salivary cortisol levels
Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
Measured: Friday of week 1
Stress as assessed by salivary cortisol levels
Cortisol levels will be measured using the Cortisol ELISA Kit (Enzo Life Sciences).
Measured: Friday of week 2
Stress as assessed by self-report
Self-reported stress on a questionnaire
Measured: baseline
Stress as assessed by self-report
Self-reported stress on a questionnaire
Measured: Friday of week 1
Stress as assessed by self-report
Self-reported stress on a questionnaire
Measured: Friday of week 2
Stress as assessed by heart rate
Self-reported stress on a questionnaire
Measured: baseline
Stress as assessed by heart rate
Self-reported stress on a questionnaire
Measured: Friday of week 1
Stress as assessed by heart rate
Self-reported stress on a questionnaire
Measured: Friday of week 2
stress reactivity as assessed by increased blood pressure
Blood pressure
Measured: baseline
stress reactivity as assessed by increased blood pressure
Blood pressure
Measured: Friday of week 1
stress reactivity as assessed by increased blood pressure
Blood pressure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?").
Measured: 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?").
Measured: 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?").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Friday of week 2
Alcohol use as assessed by self-report
Self-reported drinks per day for the past week
Measured: baseline
Alcohol use as assessed by self-report
Self-reported drinks per day for the past week
Measured: Friday of week 1
Alcohol use as assessed by self-report
Self-reported drinks per day for the past week
Measured: Friday of week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start12 May 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Ho Yoon, The University of Texas Health Science Center, Houston
- Investigators
- Jin Ho Yoon, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398252
- Sponsor's protocol ID
- HSC-MS-17-0678
- Status last verified
- Aug 2022
- First submitted
- 6 Nov 2017
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
- ClinicalTrials.gov ID
- NCT03398252
- Acronym / sponsor ID
- HSC-MS-17-0678
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 12 May 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxazosin XL | Experimental | Drug: Doxazosin XLParticipants will receive increasing doses of doxazosin XL (0, 4, and 8 mg). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a placebo for doxazosin XL. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxazosin XLAlso: Cardura XL, CarduraParticipants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg). | Drug | Doxazosin XL |
| PlaceboParticipants will be randomized to receive a placebo for doxazosin XL. | Drug | Placebo |
Primary outcome
Feasibility as study attendance
Time frame: Two weeks
Attending sessions
27 secondary outcomes
Stress as assessed by salivary cortisol levels
Time frame: baseline
Stress as assessed by salivary cortisol levels
Time frame: Friday of week 1
Stress as assessed by salivary cortisol levels
Time frame: Friday of week 2
Stress as assessed by self-report
Time frame: baseline
Stress as assessed by self-report
Time frame: Friday of week 1
Stress as assessed by self-report
Time frame: Friday of week 2
Stress as assessed by heart rate
Time frame: baseline
Stress as assessed by heart rate
Time frame: Friday of week 1
Stress as assessed by heart rate
Time frame: Friday of week 2
stress reactivity as assessed by increased blood pressure
Time frame: baseline
stress reactivity as assessed by increased blood pressure
Time frame: Friday of week 1
stress reactivity as assessed by increased blood pressure
Time frame: Friday of week 2
Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
Time frame: baseline
Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
Time frame: Friday of week 1
Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)
Time frame: Friday of week 2
Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
Time frame: baseline
Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
Time frame: Friday of week 1
Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire
Time frame: Friday of week 2
Delay discounting for alcohol as assessed by a computerized task
Time frame: baseline
Delay discounting for alcohol as assessed by a computerized task
Time frame: Friday of week 1
Delay discounting for alcohol as assessed by a computerized task
Time frame: Friday of week 2
Delay Discounting for money as assessed by a computerized task
Time frame: baseline
Delay Discounting for money as assessed by a computerized task
Time frame: Friday of week 1
Delay Discounting for money as assessed by a computerized task
Time frame: Friday of week 2
Alcohol use as assessed by self-report
Time frame: baseline
Alcohol use as assessed by self-report
Time frame: Friday of week 1
Alcohol use as assessed by self-report
Time frame: Friday of week 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Ho Yoon, PhD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxazosin XL in people with Alcohol Use Disorder, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as study attendance (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.