Adaptive Goal-Directed Adherence Tracking and Enhancement

Alcohol Abuse Clinical Trial

— AGATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349985
• Other study ID #: HHSN275201000011C
• Secondary ID: HHSN275201000011
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2011
• Last updated: May 9, 2014
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: Talaria, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Mind Research Network, University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Talaria, Inc	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.	8 weeks	No
Secondary	Indices of alcohol use, craving, etc.	Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.	8 weeks	No