Adaptive Goal-Directed Adherence Tracking and Enhancement (AGATE)
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGATE
SASED
Sponsored by
About this trial
This is an interventional supportive care trial for Alcohol Abuse focused on measuring Naltrexone, problem drinking, medication adherence, adherence, smartphone
Eligibility 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
Sites / Locations
- The Mind Research Network, University of New Mexico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AGATE
SASED
Arm 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.
The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).
Outcomes
Primary Outcome Measures
Medication adherence
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.
Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.
Full Information
NCT ID
NCT01349985
First Posted
May 5, 2011
Last Updated
May 9, 2014
Sponsor
Talaria, Inc
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT01349985
Brief Title
Adaptive Goal-Directed Adherence Tracking and Enhancement
Acronym
AGATE
Official Title
SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Talaria, Inc
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Naltrexone, problem drinking, medication adherence, adherence, smartphone
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGATE
Arm Type
Experimental
Arm 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.
Arm Title
SASED
Arm Type
Active Comparator
Arm Description
The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary).
Intervention Type
Other
Intervention Name(s)
AGATE
Intervention Description
AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
Intervention Type
Other
Intervention Name(s)
SASED
Intervention Description
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 Outcome Measure Information:
Title
Medication adherence
Description
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Indices of alcohol use, craving, etc.
Description
Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Stoner, Ph.D.
Organizational Affiliation
Talaria, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mind Research Network, University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25909320
Citation
Stoner SA, Arenella PB, Hendershot CS. Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders. PLoS One. 2015 Apr 24;10(4):e0124613. doi: 10.1371/journal.pone.0124613. eCollection 2015.
Results Reference
derived
PubMed Identifier
23186301
Citation
Stoner SA, Hendershot CS. A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders. Addict Sci Clin Pract. 2012 Jun 8;7(1):9. doi: 10.1186/1940-0640-7-9.
Results Reference
derived
Learn more about this trial
Adaptive Goal-Directed Adherence Tracking and Enhancement
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