NCT01399554

Brief Summary

Alcohol use disorders are common and few individuals with the disorder ever seek help. This study proposes to intervene in a novel way - exercise, as it has many mental and physical health benefits and is an activity that is incompatible with simultaneous alcohol use. If effective, this non-stigmatizing intervention may increase the utility and acceptability of interventions for alcohol use disorders and ultimately increase the number of individuals effectively treated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2.3 years

First QC Date

July 19, 2011

Last Update Submit

April 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Monthly drinking frequency

    Six months

Secondary Outcomes (1)

  • Monthly Exercise Behavior

    Six months

Study Arms (2)

Assessment Only

NO INTERVENTION

Weekly Exercise Counseling Intervention

EXPERIMENTAL
Behavioral: Motivational Enhancement Therapy plus Contingency Management

Interventions

A combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors.

Also known as: MET, CM
Weekly Exercise Counseling Intervention

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-55 years
  • English speaking
  • Sedentary
  • Alcohol-related problems
  • Recent heavy drinking episodes
  • Blood pressure \<165/95 mmHg

You may not qualify if:

  • Currently receiving or desiring treatment for alcohol problems
  • Contraindications for exercise
  • Acute psychiatric problems that require immediate treatment
  • Obese - class II
  • Pregnant or desire to become so in the next several months
  • Other substance dependence
  • In recovery for pathological gambling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Related Publications (1)

  • Weinstock J, Petry NM, Pescatello LS, Henderson CE, Nelson CR. Randomized clinical trial of exercise for nontreatment seeking adults with alcohol use disorder. Psychol Addict Behav. 2020 Feb;34(1):65-75. doi: 10.1037/adb0000506. Epub 2019 Aug 19.

MeSH Terms

Conditions

Alcohol-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 22, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations