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Completed

NCT Number: NCT01349985

Adaptive Goal-Directed Adherence Tracking and Enhancement

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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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Mind Research Network, University of New Mexico

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGATE

Other

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

SASED

Other

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.

Primary outcomes

  1. 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

  1. Indices of alcohol use, craving, etc.

    Time frame: 8 weeks

    Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.

Sponsors and collaborators

Lead sponsor

Talaria, Inc

Industry

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: AGATE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 9, 2011
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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