Adaptive Goal-Directed Adherence Tracking and Enhancement
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | July 2011 |
| End Date: | October 2012 |
| Contact: | Jessica Mickey |
| Email: | jmickey@mrn.org |
| Phone: | 505-272-4800 |
SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
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.
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.
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.
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.
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
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