Alcohol-Related DisordersPhase 1NCT01399554
Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults
A Phase 1 study testing Motivational Enhancement Therapy plus Contingency Management in people with Alcohol-Related Disorders, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Alcohol-Related Disorders
- What is being tested?
- Motivational Enhancement Therapy plus Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2013
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-55 years
- English speaking
- Sedentary
- Alcohol-related problems
- Recent heavy drinking episodes
- Blood pressure <165/95 mmHg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
About 26 million Americans (8.5%) meet criteria for an alcohol use disorder (AUD; i.e., abuse or dependence), and most with an AUD will not ever seek help. A variety of reasons exist for not seeking help, with stigma and desire to handle the problem on one's own being primary among them. Therefore, offering interventions for AUD that do not stigmatize or require an individual to see a mental health professional may increase the utility and acceptability of AUD interventions and ultimately increase the number of individuals effectively treated. This pilot study evaluates exercise as an AUD intervention. Exercise has been proposed as a potential treatment for AUD due to its numerous mental and physical health benefits. Thirty sedentary non-treatment seeking AUD individuals to be recruited from the community via advertisements. Participants will be given a four month YMCA gym membership and will be randomized to one of two conditions: (1) assessment only (AO), or (2) 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. Assessments of all participants will take place at baseline, 2-months (mid-treatment), and 4-months (post-treatment. Results from this pilot study will guide future investigations of exercise as a method for intervening with non-treatment seeking AUD individuals.
- Conditions
- Alcohol-Related Disorders
- Being tested
- Motivational Enhancement Therapy plus Contingency Management
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement Therapy plus Contingency ManagementBehavioural
Also called MET, CM
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.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Only | No intervention | Not described |
| Weekly Exercise Counseling Intervention | Experimental | Not described Receives: Behavioral: Motivational Enhancement Therapy plus Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly drinking frequency
Measured: Six months
Secondary outcomes (1)
Monthly Exercise Behavior
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jeremiah Weinstock, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399554
- Sponsor's protocol ID
- 1R03AA020194
- Other IDs
- 1R03AA020194
- Status last verified
- Apr 2014
- First submitted
- 19 Jul 2011
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31424244
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults
- ClinicalTrials.gov ID
- NCT01399554
- Acronym / sponsor ID
- 1R03AA020194
- Conditions
- Alcohol-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Jul 2011 (estimated)
- 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.
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.
Detailed description
About 26 million Americans (8.5%) meet criteria for an alcohol use disorder (AUD; i.e., abuse or dependence), and most with an AUD will not ever seek help. A variety of reasons exist for not seeking help, with stigma and desire to handle the problem on one's own being primary among them. Therefore, offering interventions for AUD that do not stigmatize or require an individual to see a mental health professional may increase the utility and acceptability of AUD interventions and ultimately increase the number of individuals effectively treated. This pilot study evaluates exercise as an AUD intervention. Exercise has been proposed as a potential treatment for AUD due to its numerous mental and physical health benefits. Thirty sedentary non-treatment seeking AUD individuals to be recruited from the community via advertisements. Participants will be given a four month YMCA gym membership and will be randomized to one of two conditions: (1) assessment only (AO), or (2) 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. Assessments of all participants will take place at baseline, 2-months (mid-treatment), and 4-months (post-treatment. Results from this pilot study will guide future investigations of exercise as a method for intervening with non-treatment seeking AUD individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment Only | No intervention | – |
| Weekly Exercise Counseling Intervention | Experimental | Behavioral: Motivational Enhancement Therapy plus Contingency Management |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 21-55 years
- English speaking
- Sedentary
- Alcohol-related problems
- Recent heavy drinking episodes
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Motivational Enhancement Therapy plus Contingency ManagementAlso: MET, CMA 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. | Behavioural | Weekly Exercise Counseling Intervention |
Primary outcome
Monthly drinking frequency
Time frame: Six months
1 secondary outcome
Monthly Exercise Behavior
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Derived from this study: PubMed 31424244Weinstock 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational Enhancement Therapy plus Contingency Management in people with Alcohol-Related Disorders, run by St. Louis University at 1 site in United States.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Monthly drinking frequency (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399554, which also lists 1 linked publication.
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 7 Apr 2014.