Adaptive Goal-Directed Adherence Tracking and Enhancement

Study Overview
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Brief Summary
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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
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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.

Official Title
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SBIR-PhaseII, Adaptive Goal-Directed Adherence Tracking and Enhancement

Conditions
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Alcohol Abuse

Intervention / Treatment
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* Other: AGATE
* Other: SASED


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGATE<br>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<br>* AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.<br>|
| Active Comparator: SASED<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, Naltrexone, problem drinking, medication adherence, smartphone