NCT02918565

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,131

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

September 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 5, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

September 23, 2016

Results QC Date

May 4, 2023

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Binge Drinking Days

    Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks

    12 weeks after starting intervention

Secondary Outcomes (3)

  • Drinks Per Drinking Day

    12 weeks after starting intervention

  • Count of Participants With Any Binge Drinking Day

    12 weeks after starting intervention

  • Brief Young Adult Alcohol Consequences Questionnaire Score

    12 weeks after starting intervention

Study Arms (5)

Drinking Cognition Feedback (DCF)

EXPERIMENTAL

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)

Alcohol Risk Feedback (ARF)

EXPERIMENTAL

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)

Adaptive Goal Support (AGS)

EXPERIMENTAL

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)

COMBO

EXPERIMENTAL

12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.

Behavioral: COMBO

Control

NO INTERVENTION

12 weeks of text message assessments without any feedback

Interventions

12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).

Drinking Cognition Feedback (DCF)

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).

Alcohol Risk Feedback (ARF)

12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).

Adaptive Goal Support (AGS)
COMBOBEHAVIORAL

12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.

COMBO

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center Emergency Department

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

  • Chung T, Suffoletto B, Bhurosy T. Which intervention works for whom: Identifying pre-treatment characteristics that predict who will benefit from a specific alcohol text message intervention from a randomized trial. J Subst Use Addict Treat. 2025 Jan;168:209562. doi: 10.1016/j.josat.2024.209562. Epub 2024 Nov 4.

  • Bae SW, Suffoletto B, Zhang T, Chung T, Ozolcer M, Islam MR, Dey AK. Leveraging Mobile Phone Sensors, Machine Learning, and Explainable Artificial Intelligence to Predict Imminent Same-Day Binge-drinking Events to Support Just-in-time Adaptive Interventions: Algorithm Development and Validation Study. JMIR Form Res. 2023 May 4;7:e39862. doi: 10.2196/39862.

  • Suffoletto B, Field M, Chung T. Attentional and approach biases to alcohol cues among young adult drinkers: An ecological momentary assessment study. Exp Clin Psychopharmacol. 2020 Dec;28(6):649-658. doi: 10.1037/pha0000343. Epub 2019 Dec 30.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Brian Suffoletto
Organization
Stanford University

Study Officials

  • Brian Suffoletto, MD MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 29, 2016

Study Start

December 1, 2016

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

December 5, 2023

Results First Posted

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

De-identified dataset provided upon request

Locations