SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Talaria, Inc
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Medication adherence
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
AGATE
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.
Intervention: AGATE (Other)
SASED
The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).
Intervention: SASED (Other)
Outcomes
Primary Outcomes
Medication adherence
Time Frame: 8 weeks
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
Secondary Outcomes
- Indices of alcohol use, craving, etc.(8 weeks)