Adaptive Goal-Directed Adherence Tracking and Enhancement (AGATE)

Talaria

Status and phase: Completed; Phase 2

Conditions: Alcohol Abuse

Treatments: Other: AGATE; Other: SASED

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01349985

HHSN275201000011C (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

AGATE

Experimental group

Description:

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.

Treatment:

Other: AGATE

SASED

Active Comparator group

Description:

The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).

Treatment:

Other: SASED