NCT02664766

Brief Summary

The purpose of this research is to examine the effects of long-term aerobic exercise of moderate intensity on psychological, physiological, biochemical, physiological and alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

January 18, 2016

Last Update Submit

January 26, 2016

Conditions

Heavy DrinkingAlcohol AbuseAlcohol Use Disorder

Keywords

Heavy drinkingHeavy drinking cessationAlcohol abusealcohol use disorder

Outcome Measures

Primary Outcomes (2)

  • Changes in alcohol consumption (grams of alcohol consumed weekly)

    Self-recorded

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

  • Changes in Beta-endorphin levels

    Measured by radioimmunoassay (RIA)

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

Secondary Outcomes (15)

  • Urge to drink

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

  • Cortisol

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

  • Adrenocorticotrophic hormone (ACTH)

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

  • Catecholamines (epinephrine, norepinephrine, dopamine)

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

  • C-reactive protein (CRP)

    At baseline and at 4th week of control condition; at baseline (before intervention), at 4th week and at 8th week of intervention

  • +10 more secondary outcomes

Study Arms (2)

Control condition

NO INTERVENTION

Control condition with no intervention. Participants will be recording their daily alcohol consumption. No lifestyle modification during this period.

Exercise training program

EXPERIMENTAL

Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week.

Behavioral: Exercise training program

Interventions

Exercise training programBEHAVIORAL

Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. Participants will be recording their daily alcohol consumption. Participants will also undergo three trials of acute exercise (before, at the 4th week and at the 8th week of exercise training) in order to investigate whether exercise training can lead to changes in acute responses to exercise. Each trial involves 30 min of exercise on a cycle ergometer at 50-60% HRR.

Exercise training program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men drinking \>14 drinks/week or \>4 drinks/occasion; Women drinking \>7 drinks/week or \>4 drinks/occasion (1 drink = 14 grams of pure alcohol; definition of the NIAAA for drinking at low risk for developing an AUD; NIAAA, 2014)
  • Individuals drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days (1 drink = 14 grams of pure alcohol; definition of the Substance Abuse and Mental Health Services Administration for heavy drinking; NIAAA, 2014) Alcohol Use Disorders Identification Test (AUDIT) score\>8

You may not qualify if:

  • Medical conditions or medication use that would preclude participation in aerobic exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Yannis Theodorakis, PhD

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 27, 2016

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

June 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share