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Adaptive Goal-Directed Adherence Tracking and Enhancement (AGATE)

This study is currently recruiting participants.
Verified September 2011 by Talaria, Inc
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Talaria, Inc
ClinicalTrials.gov Identifier:
NCT01349985
First received: May 5, 2011
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
 Device: AGATE
Device: SASED
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Talaria, Inc:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.


Secondary Outcome Measures:
  • Indices of alcohol use, craving, etc. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.


Estimated Enrollment: 105
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Device: AGATE
AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
Active Comparator: SASED
The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).
 Device: SASED
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349985

Contacts
Contact: Jessica Mickey 505-272-4800 jmickey@mrn.org

Locations
United States, New Mexico
The Mind Research Network, University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Christian Hendershot, Ph.D.     505-504-1102     chendershot@mrn.org    
Principal Investigator: Christian Hendershot, Ph.D.            
Sponsors and Collaborators
Talaria, Inc
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Susan Stoner, Ph.D. Talaria, Inc
  More Information

No publications provided by Talaria, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Talaria, Inc
ClinicalTrials.gov Identifier: NCT01349985     History of Changes
Other Study ID Numbers: HHSN275201000011C, HHSN275201000011C
Study First Received: May 5, 2011
Last Updated: September 12, 2011
Health Authority: United States: Federal Government

Keywords provided by Talaria, Inc:
Naltrexone
problem drinking
medication adherence
adherence
smartphone

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013