Adaptive Goal-Directed Adherence Tracking and Enhancement
AGATE
SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
1 other identifier
interventional
136
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMay 13, 2014
May 1, 2014
1.6 years
May 5, 2011
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
8 weeks
Secondary Outcomes (1)
Indices of alcohol use, craving, etc.
8 weeks
Study Arms (2)
AGATE
EXPERIMENTALTo 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.
SASED
ACTIVE COMPARATORThe control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).
Interventions
AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Mind Research Network, University of New Mexico
Albuquerque, New Mexico, 87106, United States
Related Publications (2)
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.
PMID: 25909320DERIVEDStoner 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.
PMID: 23186301DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Stoner, Ph.D.
Talaria, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 9, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 13, 2014
Record last verified: 2014-05