Clinical trial NCT01349985: Adaptive Goal-Directed Adherence Tracking and Enhancement
Official title: SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Abuse
Keywords: Naltrexone
problem drinking
medication adherence
adherence
smartphone
Lead sponsor: Talaria, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2011-05-09
Enrollment: 136
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Medication adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Indices of alcohol use, craving, etc.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The Mind Research Network, University of New Mexico
state: New Mexico
Study officials:
affiliation: Talaria, Inc
name: Susan Stoner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.