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Open Access Study Protocol

A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders

Susan A Stoner12* and Christian S Hendershot345

Author Affiliations

1 Talaria, Inc, 1121 34th Ave, Seattle, WA, 98122, USA

2 Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, BB-1469, Seattle, WA, 98195, USA

3 Centre for Addiction and Mental Health, 33 Russell Street, Toronto, ON, M5S 2S1, Canada

4 Department of Psychiatry, University of Toronto, 250 College Street, Toronto, ON, M5T 1R8, Canada

5 The Mind Research Network, 1101 Yale Boulevard NE, Albuquerque, NM, 87106, USA

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Addiction Science & Clinical Practice 2012, 7:9  doi:10.1186/1940-0640-7-9

Published: 8 June 2012

Abstract

Background

Nonadherence to prescribed medication regimens is a substantial barrier to the pharmacological management of alcohol use disorders. The availability of low-cost, sustainable interventions that maximize medication adherence would likely lead to improved treatment outcomes. Mobile health (mHealth) technologies are increasingly being adopted as a method of delivering behavioral health interventions and represent a promising tool for adherence interventions. We are evaluating a cell-phone–based intervention called AGATE that seeks to enhance adherence with regular text-messaging.

Methods/Design

A randomized controlled effectiveness trial in the context of an eight-week open label naltrexone efficacy trial delivered in a naturalistic clinical setting. Treatment-seeking heavy drinkers (N = 105) are currently being recruited and randomly assigned to the AGATE intervention or a control condition. Daily measures of alcohol use and medication side effects are being recorded via cell phone in both conditions. Additionally, participants randomized to the AGATE condition receive medication reminders via SMS text message according to a schedule that adjusts according to their level of adherence.

Discussion

Results from this trial will provide initial information about the feasibility and efficacy of mHealth interventions for improving adherence to alcohol pharmacotherapies.

Trial Registration

NCT01349985.

Keywords:
Alcohol dependence; Medication adherence; mHealth; Internet intervention; Opioid antagonist