Skip to content

Adaptive Goal-Directed Adherence Tracking and Enhancement

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01349985
Acronym
AGATE
Enrollment
136
Registered
2011-05-09
Start date
2011-07-31
Completion date
2013-02-28
Last updated
2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse

Keywords

Naltrexone, problem drinking, medication adherence, adherence, smartphone

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.

Interventions

OTHERAGATE

AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.

OTHERSASED

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Talaria, Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication adherence8 weeksAdherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.

Secondary

MeasureTime frameDescription
Indices of alcohol use, craving, etc.8 weeksIndicies of alcohol use, cravings etc will be measured using validated patient self report measures.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026