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Multi-Component Breath Alcohol Intervention Phase 3

ConditionsAlcohol UseAlcohol DrinkingDrinking Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorNortheastern University

About this trial

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be between the ages of 18-25

Be able to read English and complete study evaluations

Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days

Report having consumed at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.

Disqualifiers

Have been in inpatient or intensive outpatient treatment within the past 12 months

Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months

Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.

History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Alcohol-related mobile health technologies

    Device

    Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.

  • Motivational interview and psychoeducation on blood/breath alcohol concentration

    Behavioral

    Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.

  • Lower tech facilitation

    Behavioral

    Study staff will review instructions for technology use closely with participants and guide them in use of existing phone technologies as reminders for use of the three moderate drinking technologies during drinking situations.

  • Higher tech facilitation

    Behavioral

    Participants will use an app developed during the study, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.

  • Alcohol Education

    Behavioral

    Brief 25/30-minute psychoeducation on generalized alcohol use providing information about alcohol and its effects, adapted from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rethinking Drinking resources

  • Alcohol Education Technology

    Device

    Participants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Moderate drinking technologies with "lower tech" facilitationExperimental treatment 3 interventions
Group B: Moderate drinking technologies with "higher tech" facilitationExperimental treatment 3 interventions
Group C: Alcohol Education ConditionActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Technology utilization

Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred

Time frame
4-week field use period
2

Acceptability

Score on acceptability subscale of Modified System Usability Scale

Time frame
4-week field use period
3

Usability

Score on acceptability subscale of Modified System Usability Scale

Time frame
4-week field use period

Secondary outcomes

1

Drinks per drinking day

Number of drinks per day during field testing period

Time frame
4-week field use period
2

Estimated blood alcohol content

Average estimated blood alcohol content reached on drinking days

Time frame
4-week field use period
3

Negative Consequences

Score on the Young Adult Alcohol Consequences Questionnaire

Time frame
4-week field use period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northeastern University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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