Alcohol AbusePhase 2AGATENCT01349985
Adaptive Goal-Directed Adherence Tracking and Enhancement
A Phase 2 study testing AGATE and SASED in people with Alcohol Abuse, run by Talaria, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- AGATE and SASED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Mind Research Network, University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Abuse
- Being tested
- AGATE, SASED
- Keywords
- Naltrexone, problem drinking, medication adherence, adherence, smartphone
- Medical subject headings
- Alcoholism, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGATEOther
AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
SASEDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AGATE | Experimental | 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. Receives: Other: AGATE |
| SASED | Active comparator | The control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary). Receives: Other: SASED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
Measured: 8 weeks
Secondary outcomes (1)
Indices of alcohol use, craving, etc.
Indicies of alcohol use, cravings etc will be measured using validated patient self report measures.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talaria, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Susan Stoner, Ph.D., Principal investigator, Talaria, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349985
- Sponsor's protocol ID
- HHSN275201000011C
- Other IDs
- HHSN275201000011C
- Acronym
- AGATE
- Status last verified
- May 2014
- First submitted
- 5 May 2011
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25909320Stoner 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.
PubMed 23186301
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBIR-PhaseII, "Adaptive Goal-Directed Adherence Tracking and Enhancement"
- ClinicalTrials.gov ID
- NCT01349985
- Acronym / sponsor ID
- AGATE / HHSN275201000011C
- Conditions
- Alcohol Abuse
- Keywords
- Naltrexone, problem drinking, medication adherence, adherence, smartphone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Talaria, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGATE | Experimental | Other: AGATETo 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. |
| SASED | Active comparator | Other: SASEDThe control condition for the proposed study is a smartphone alcohol and side-effects diary (SASED, a smartphone alcohol and side effects diary). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- participation in other naltrexone study
- unable to operate a smartphone
- significant psychiatric or physical illness
- current drug dependence
- current regular opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGATEAGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks. | Other | AGATE |
| SASEDParticipants 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. | Other | SASED |
Primary outcome
Medication adherence
Time frame: 8 weeks
Adherence will be measured using the medication event monitoring system (MEMS), pill counts, and multiple self-report indices.
1 secondary outcome
Indices of alcohol use, craving, etc.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Derived from this study: PubMed 25909320Stoner 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.
- Derived from this study: PubMed 23186301Stoner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Stoner, Ph.D. principal investigator
Talaria, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGATE and SASED in people with Alcohol Abuse, run by Talaria, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01349985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.