Combining a Smartphone App With Medications to Manage Heavy Drinking

Conditions

• Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Stand Down mobile app — OTHER
  The Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support.
• Standard Care — OTHER
  Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.

Study Details

One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.

Key Dates

Start date

Nov 1, 2024

Status verified

Oct 2025

Primary completion

Nov 1, 2028

Completion

Nov 1, 2028

Study Design

Enrollment

330 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Standard Care
  Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.
• Experimental: Combined MAUD+SD-App
  In addition to standard MAUD care, participants assigned to the MAUD+SD-App condition will receive access to the Stand Down app at randomization.

Primary Outcome Measure

Change in Percent Heavy Drinking Days [ Time Frame: 6 months post-baseline ]

Central Contacts

• Eric J Hawkins, PhD
  (206) 764-2743
  [email protected]
• Anissa N Danner, MSW BA
  (206) 277-4878
  [email protected]

Locations (15)

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