Adaptive Goal-Directed Adherence Tracking and Enhancement (AGATE)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"|
- Medication adherence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
- Indices of alcohol use, craving, etc. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.
|Study Start Date:||July 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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.
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).
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349985
|United States, New Mexico|
|The Mind Research Network, University of New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Susan Stoner, Ph.D.||Talaria, Inc|