Adaptive Goal-Directed Adherence Tracking and Enhancement (AGATE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01349985|
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : May 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Abuse||Other: AGATE Other: SASED||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"|
|Study Start Date :||July 2011|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
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.
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).
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.
- Medication adherence [ Time Frame: 8 weeks ]Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349985
|United States, New Mexico|
|The Mind Research Network, University of New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Susan Stoner, Ph.D.||Talaria, Inc|