ClinicalTrials.gg
RecruitingNCT05522075Updated Jun 1, 2026

Reducing Blood Pressure in Mid-life Adult Binge Drinkers

An interventional study of Exercise Training and Alcohol Abstinence Intervention in Alcohol Drinking, Binge Drinking and Blood Pressure, sponsored by The University of Texas at Arlington. Recruiting at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Primary conditionBinge DrinkingRegistry: Alcohol DrinkingReclassifiedWhy we changed it
Registry
Alcohol Drinking — the first condition term the registry derived for this study.
ClinicalTrials.gg
Binge Drinking
Why
  1. Alcohol Drinking is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Binge Drinking, a narrower term within Alcohol Drinking.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The University of Texas at Arlington · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
50 Years to 64 Years
Sex
All
01

Study summary

This study has two phases:

Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers.

Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers

Read the detailed description

During phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. Only mid-life adult binge drinkers will enter Phase 2 and be randomized to the exercise training group and non-exercise control group. After 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.

02

Conditions studied

  • Alcohol Drinking
  • Binge Drinking
  • Blood Pressure
  • Alcohol Abstinence
  • Aging
  • Lifestyle Factors
  • Vasodilation
  • Behavioral Problem

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Keywords

  • Exercise training
  • High-intensity interval training
  • Midlife adults
  • Middle-aged
  • Microvascular function
  • Sympathetic nerve activity
03

In context

Binge Drinking Reclassified

71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.

This study's planned enrollment of 55 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.

Browse Binge Drinking studies →

Lead sponsor

The University of Texas at Arlington is the lead sponsor of 39 studies on the registry; 12 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Compared within Binge Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
50 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink
  • Female subjects will be (i.e., cessation of menses for ≥1 yr).
  • Subjects who can speak and understand English.

Exclusion criteria

Exclusion Criteria:

  • a history of diabetes, cardiovascular disease, liver, or renal disease
  • current or history of smoking and illicit drug use
  • blood pressure ≥160/100 mm Hg
  • other known traditional cardiovascular disease risks: obesity (≥35 kg/m2), or hyperlipidemia (total cholesterol>230 mg/dl and/or LDL cholesterol>160 mg/dl)
  • active infection (in the past 2 months)
  • a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid)
  • unstable body weight (>5% change during the past 6 months)
  • regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week)
  • current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Exercise Group

    Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment.

    Behavioral: Exercise Training · Behavioral: Alcohol Abstinence Intervention

  • Active comparator
    Non-exercise Group

    Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.

    Behavioral: Alcohol Abstinence Intervention

  • No intervention
    Alcohol abstainer/moderate drinker group

    Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.

Interventions

  • BehavioralExercise Training

    Subjects will be asked to perform exercise training (high-intensity interval training) under supervision, 3 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.

  • BehavioralAlcohol Abstinence Intervention

    Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.

06

What researchers measure

Primary outcomes

  1. Feasibility of high-intensity interval training

    Recruitment capacity (e.g., how many subjects respond and enter to the study or reasons of refusal), resulting subject characteristics, the number of exercise session attended, and the number of dropouts

    Time frame: Through out the study participation (~3 months)

Secondary outcomes

  1. Changes in microvascular function

    A small amount of fat will be taken form the buttock. Small vessels will then be found in the fat and their sizes in response to various flows and chemical agents will be measured.

    Time frame: Baseline and after an 8-week intervention

  2. Changes in sympathetic activity

    A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).

    Time frame: Baseline and after an 8-week intervention

  3. Changes in urine catecholamine levels

    Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)

    Time frame: Baseline and after an 8-week intervention

  4. Changes in blood pressure

    Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.

    Time frame: Baseline and after an 8-week intervention

  5. Changes in alcohol intake

    Questionnaires will be used to determine alcohol intake.

    Time frame: Baseline and after an 8-week intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — We will submit to the NIMH Data Archive human subjects' data that were collected as part of the "Research Project" including microvascular function, sympathetic activity, and blood pressure. These data will be made accessible to authorized users for the purpose of scientific investigation, scholarship or teaching, or other forms of research and research development.

Time frame: Data will be shared with authorized users upon publication (via an NDA Study) or 1-2 years after the grant end date (04/30/2026).

Access criteria: Submit a Data Access Request to NDA and get approval

Data sharing details ↗ · nda.nih.gov

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Dec 2026, 49 months after the start.

Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 49 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2022
First posted
Aug 30, 2022
StartActual
Nov 21, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Apr 30, 2027
Last update
Jun 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05522075
Lead sponsor
The University of Texas at Arlington
Responsible party
Sponsor
First posted
Aug 30, 2022
Start date
Nov 21, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Chueh-Lung Hwang, PhD
Contact
chuehlung.hwang@uta.edu
8172729722
Chueh-Lung Hwang, PhD
principal investigator · University of Texas at Arlington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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