Adaptive Goal-Directed Adherence Tracking and Enhancement (AGATE)

SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"

Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which uses the text messaging and internet capabilities of modern cellular phones to address the problem of medication adherence in clinical care and clinical trial contexts. This trial will evaluate whether AGATE improves medication adherence in the context of a pharmacotherapy trial of naltrexone to treat problem drinking. All participants will be treatment-seeking problem drinkers who will receive naltrexone and medication monitoring over 8 weeks.

Study Overview

• Status: Completed
• Conditions: Alcohol Abuse
• Intervention / Treatment: Other: AGATE; Other: SASED

Detailed Description

The purpose of the naltrexone trial is to evaluate whether AGATE effectively measures and enhances medication adherence in the context of naltrexone treatment for problem drinking. Participants will be heavy/problem drinkers, recruited from the greater Albuquerque area, who are interested in either reducing or stopping their drinking and deemed to be candidates for naltrexone pharmacotherapy by the study psychiatrist, Dr. Arenella. All participants will be prescribed naltrexone, 50 mg, once daily, for eight weeks, and receive smartphones. Participants will be randomly assigned to receive either AGATE or SASED, a web-based alcohol and side-effects diary via smartphone. The primary outcome will be percent of scheduled doses that were taken during the eight week trial, as measured by the Medication Event Monitoring System (MEMS, Aardex Group, Union City, CA), pill counts, and using the timeline follow-back (TLFB) method.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • The Mind Research Network, University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• problem or heavy drinkers
• age 21-55 years old
• located in the greater Albuquerque NM area
• interested in either reducing or stopping their drinking
• candidates for naltrexone pharmacotherapy

Exclusion Criteria:

• participation in other naltrexone study
• unable to operate a smartphone
• significant psychiatric or physical illness
• current drug dependence
• current regular opioid use
• any recent nonmedical opioid use
• any lifetime opioid dependence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGATE; To evaluate whether AGATE, a smartphone medication reminder and assessment system, effectively measures and enhances medication adherence in the context of naltrexone treatment for problem drinking.	Other: AGATE; AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
Active Comparator: SASED; The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).	Other: SASED; Participants will receive SASED, a web-based alcohol and side-effects diary via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indices of alcohol use, craving, etc.	Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.	8 weeks

Collaborators and Investigators

• Sponsor: Talaria, Inc
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Susan Stoner, Ph.D., Talaria, Inc

Publications and helpful links

General Publications

• Stoner SA, Arenella PB, Hendershot CS. Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders. PLoS One. 2015 Apr 24;10(4):e0124613. doi: 10.1371/journal.pone.0124613. eCollection 2015.
• Stoner SA, Hendershot CS. A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders. Addict Sci Clin Pract. 2012 Jun 8;7(1):9. doi: 10.1186/1940-0640-7-9.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (Estimate): May 9, 2011

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: adherence; smartphone; Naltrexone; medication adherence; problem drinking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: HHSN275201000011C (Other Identifier: NIAAA SBIR Contract)