NCT01349985

Adaptive Goal-Directed Adherence Tracking and Enhancement

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Talaria, Inc · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Alcohol Abuse

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-05-09
• Last updated: 2014-05-13

Locations

1 site across 1 country: United States