Clinical trial NCT02664727: Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders
Official title: Effects of Acute Exercise on Psychological, Physiological, Biochemical and Alcohol-related Parameters in Individuals With Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Alcohol Abuse
Alcohol Dependence
Alcohol Use Disorder
Keywords: alcohol
alcohol abuse
alcohol dependence
alcohol use disorder
heavy drinking
alcohol abuse cessation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: European Social Fund
First posted: 2016-01-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to examine the effects of exercise of different intensities on psychological, physiological, biochemical, physiological and alcohol-related parameters in individuals with alcohol use disorders (heavy drinkers and alcoholic patients) in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse. For that purpose, a control group of individuals that do not exceed the limits for moderate alcohol use will be included.

Detailed description: The mechanism of incentives that lead people to unhealthy habits such as excessive alcohol consumption is not only social, personal, and psychological, but also associated with neurochemical and neurobiological mechanisms.

Several programs have been developed to stop excessive drinking, but the success rates are small, while the relapse rates are very high, reaching up to 90%. Although there is some evidence for the beneficial effects of exercise on alcohol use disorders (AUDs), research is limited. The present study investigates whether exercise could be a safe adjunct therapy for alcohol abuse cessation, and the possible mechanisms involved.

One of the basic assumptions is that the appropriate form of exercise in individuals with AUDs will contribute to the secretion of beta-endorphin, which in combination with psychological pleasure, vitality, change of mood, reduced stress, increased confidence, and the shift of attention will help people to follow healthy lifestyles and abhor alcohol.

The research project is divided in three phases. In the first phase, (current study) the effect of acute exercise in critical psychological, physiological, biochemical and alcohol-related parameters associated with excessive alcohol consumption will be examined. In the second phase, a long-term exercise program in conjunction with psychological support strategies aimed at alcohol abuse cessation will be developed, implemented and evaluated. Finally, in the third phase, based on the results of the previous phases, awareness programs in adolescent and adult populations will be designed and implemented as well as the dissemination of results and evaluation of the project will take place.

Eligibility criteria: For alcoholics:

Inclusion Criteria:

* Confirmed alcohol addiction according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria in the past, after detoxification phase, lack of dependence on other substances
* Alcohol Use Disorders Identification Test (AUDIT) score\>20

Exclusion Criteria:

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

For heavy drinkers:

Inclusion Criteria:

* 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 National Institute on Alcohol Abuse and Alcoholism (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)
* AUDIT score\>8

Exclusion Criteria:

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

For healthy controls:

Inclusion Criteria:

* 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 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)
* AUDIT score\<8

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in Urge to drink score
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Beta-endorphin levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Cortisol levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Adrenocorticotrophic hormone (ACTH) levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Catecholamines (epinephrine, norepinephrine, dopamine) levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in C-reactive protein (CRP) levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Complete blood count values
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Lactic acid levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Erythrocyte sedimentation rate (ESR) values
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in γ-Glutamyltransferase (GGT) levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Aspartate Aminotransferase (AST) levels
timeFrame: Before (0 min) and after exercise trial (30 min)
measure: Changes in Alanine Aminotransferase (ALT) levels
timeFrame: Before (0 min) and after exercise trial (30 min)
Secondary outcomes:
measure: Sit and reach flexibility test for the hamstrings muscles and lower back
timeFrame: Before trial (baseline)
measure: Grip strength
timeFrame: Before trial (baseline)
measure: Number of push-ups performed in one minute
timeFrame: Before trial (baseline)
measure: Number of sit-ups performed until exhaustion
timeFrame: Before trial (baseline)
Other outcomes:
Locations:
Study officials:
affiliation: University of Thessaly
name: Yannis Theodorakis, PhD
role: STUDY_CHAIR
References:
citation: Georgakouli K, Manthou E, Fatouros IG, Deli CK, Spandidos DA, Tsatsakis AM, Kouretas D, Koutedakis Y, Theodorakis Y, Jamurtas AZ. Effects of acute exercise on liver function and blood redox status in heavy drinkers. Exp Ther Med. 2015 Dec;10(6):2015-2022. doi: 10.3892/etm.2015.2792. Epub 2015 Oct 13.