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Mechanisms for Alcohol Treatment Change [MATCH] Study (MATCH)

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ClinicalTrials.gov Identifier: NCT02918565
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Brian Suffoletto, University of Pittsburgh

Brief Summary:
A 5-arm randomized trial to determine what components of a text message intervention are necessary to reduce hazardous drinking among young adults and mechanisms through which these changes occur.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Behavioral: Drinking Cognition Feedback (DCF) Behavioral: Alcohol Risk Feedback (ARF) Behavioral: Adaptive Goal Support (AGS) Behavioral: COMBO Not Applicable

Detailed Description:
Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related consequences. The Emergency Department (ED) provides an important opportunity to identify young adult hazardous drinkers who could benefit from interventions. A Text Message (TM) intervention was shown to reduce alcohol consumption among young adult ED patients, showing durable effects over 9-months. The TM intervention uses behavior change techniques with the largest effect sizes in an alcohol intervention meta-analysis: "goal commitment" and "self-monitoring", along with real-time "feedback". However, the unique effect of these ingredients, and mechanisms (processes occurring within the individual) through which they operate to reduce drinking remain unclear, a critical gap addressed by this project. Young adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited to participate in a randomized trial to determine how best to help individuals reduce hazardous drinking. All participants will be asked to complete web-based surveys at baseline, 12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and respond to text messages each Thursday and Sunday for the next 12 weeks. Those randomized to the TM interventions will additionally receive feedback on their text reports. The four TM intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO). Study results have implications for designing efficient mobile interventions, and developing a dynamic theory of behavior change.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1875 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanisms for Alcohol Treatment Change [MATCH] Study
Study Start Date : December 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Drinking Cognition Feedback (DCF)
12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
Behavioral: Drinking Cognition Feedback (DCF)
12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).

Experimental: Alcohol Risk Feedback (ARF)
12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
Behavioral: Alcohol Risk Feedback (ARF)
12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).

Experimental: Adaptive Goal Support (AGS)
10 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
Behavioral: Adaptive Goal Support (AGS)
12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).

Experimental: COMBO
12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
Behavioral: COMBO
12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.

No Intervention: Control
12 weeks of text message assessments without any feedback



Primary Outcome Measures :
  1. Number of binge drinking episodes [ Time Frame: 12 weeks after starting intervention ]
    defined as: 4 or more drinks per day for women and 5 or more drinks per day for men


Secondary Outcome Measures :
  1. Drinks per drinking day [ Time Frame: 12 weeks after starting intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total score of >2 for women or >3 for men on the AUDIT-C
  • at least 1 binged drinking episode in the prior 30 days

Exclusion Criteria:

  • no cell phone with text messaging
  • have been diagnosed with an alcohol or substance use disorder
  • pregnant or planning pregnancy
  • taking medicine for a psychiatric disorder (including depression, anxiety)
  • taking any medicine that could interact with alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918565


Contacts
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Contact: Brian Sufffoletto, MD MS 412-901-6892
Contact: Ryan Kurtz 412-647-6999

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Emergency Department Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Brian Suffoletto, MD MSc       suffbp@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Brian Suffoletto, MD MS University of Pittsburgh

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Responsible Party: Brian Suffoletto, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02918565     History of Changes
Other Study ID Numbers: PRO16080422
R01AA023650 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified dataset provided upon request

Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs