The Mind Research Network, University of New Mexico
Albuquerque, New Mexico, 87106, United States
NCT Number: NCT01349985
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.
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Notify Me21 year–55 year
All sexes
Interventional
Phase 2
Albuquerque, New Mexico, 87106, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
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.
Time frame: 8 weeks
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
Time frame: 8 weeks
Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.
Talaria, Inc
Industry
SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
Acronym: AGATE
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