Adaptive Goal-Directed Adherence Tracking and Enhancement

Phase 2

Completed

• Conditions: Alcohol Abuse

• Registration Number: NCT01349985
• Lead Sponsor: Talaria, Inc

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.

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 Timeline

• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Study Start: 2011-07
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Indices of alcohol use, craving, etc.	8 weeks	Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.

Trial Locations

Locations (1)

The Mind Research Network, University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States