Alcohol DependenceNCT02385643
The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
A study testing SmartPhone Support System in people with Alcohol Dependence, run by Ming-Chyi Huang at 1 site in Taiwan.
Trial summary
Background: Interactive and mobile technology to manage alcohol use problem potentially provide continuing care by offering emotional and instrumental support anywhere and in time, but the effectiveness for maintaining abstinence has not been examined. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- SmartPhone Support System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Jul 2017
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 50 years;
- Use an Android phone as his/her primary phone, or be willing to use an Android phone provided by National Taiwan University as his/her primary phone during the study;
- Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of alcohol dependence assessed by the Structured Clinical Interview;
- Complete abstinence for at least 10 days and free of any withdrawal symptoms; and
- Drug screening test results negative opiates, amphetamines, and ketamine.
Who cannot join
- A current DSM-IV diagnosis of dependence or abuse on other substances except nicotine or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
- A current mental or psychiatric impairment or disease that required psychotropic medication or inpatient treatment on a psychiatric ward;
- A history of opioid or psychostimulant abuse;
- A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;
- Current use of any antipsychotics;
- Homelessness;
- Pregnancy, nursing, or refusal to use a reliable method of birth control in women;
- Cognitive deficit and not thus being able to comprehend the informed consent and study procedure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ming-Chyi
Taipei, 110
Ming-Chyi Huang, M.D., Ph.D, 886-2-27263141 ext. 1219, mch@tpech.gov.tw
Galen Hung, M.D., 886-2-27263141 ext. 1305, galenhung@gmail.com
About this study
Background: Interactive and mobile technology to manage alcohol use problem potentially provide continuing care by offering emotional and instrumental support anywhere and in time, but the effectiveness for maintaining abstinence has not been examined. the investigators will evaluate in this study whether the smartphone-based support system would improve outcomes for people in recovery for alcohol dependence. To enable continuous self-monitoring and self-management, the phone support system prompts subjects to take Breath Alcohol Concentration (BrAC) tests using a phone application and a Bluetooth sensor unit. The system also offers instantaneous feedback, self-management strategies, and anonymous mutual social support from other subjects.
Methods: This three-year project will be conducted in three stages, including pilot study, efficacy evaluation (12 week), and post-intervention follow-up (12 week) stage. Participants will be given a smartphone (if the subject does not have one), breathalyzer and training session. In the pilot study stage,10 subjects will be enrolled to validate the system. In the efficacy evaluation stage, the investigators will conduct a 12-week by enrolling 100 post-detoxification alcohol dependent patients who are randomized to (1) standard treatment (ST) group or (2) standard treatment plus phone-based support group (technology intervention, TI group). Participants will be assessed by Time-Line Follow-Back (TLFB) to record the frequency and quantity of alcohol consumption, visual analogue for craving, Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI), Satisfaction with Life Scale (SWLS), and Quality of life Scale (WHOQOL-BREF) and compared for outcome measures. After the 12-week trial, the investigators will take back the support system and follow the all subjects in both groups for another 12 weeks, i.e. post-intervention stage, to further understand the sustaining benefit from intervention. In addition, the investigators will identify the clinical variables or system factors that are associated with outcome measures.
Expected results: In this study, the investigators expect that in treatment-seeking alcohol dependent patients, a smartphone-supported self-management program, adding on to conventional treatment, will be beneficial in improving the drinking outcomes such as a higher abstinence rate, a lower relapse rate, and a lower drinking frequency and quantity.
- Conditions
- Alcohol Dependence
- Being tested
- SmartPhone Support System
- Keywords
- alcohol dependence, abstinence, relapse prevention, mobile support system
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartPhone Support SystemBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group of subjects receives mobile support system and conventional treatment Receives: Behavioral: SmartPhone Support System |
| Control group | No intervention | This group of patients receive conventional treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first lapse
Measured: 12 weeks
Time to first relapse
Measured: 12 weeks
Cumulative abstinence days
Measured: 12 weeks
Number of drinks per drinking days
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Measured: 12 weeks
VAS craving measurement
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Measured: 12 weeks
complete abstinence rate
Measured: 12 weeks
Drop-out rate
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Chyi Huang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ming-Chyi Huang, Taipei City Hospital
- Investigators
- Ming-Chyi Huang, MD, PhD, Principal investigator, Taipei City Psychiatric CenterHao-Hua Chu, PhD, Study chair, Department of Computer Science and Information Engineering, National Taiwan UniversityChuang-Wen You, PhD, Study director, Intel-NTU Connected Context Computing Center, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385643
- Sponsor's protocol ID
- MOST 103-2628-B-532 -001 -MY3
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
- ClinicalTrials.gov ID
- NCT02385643
- Acronym / sponsor ID
- MOST 103-2628-B-532 -001 -MY3
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, abstinence, relapse prevention, mobile support system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ming-Chyi HuangOther government
- Study start
- Sep 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 11 Mar 2015 (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.
Background: Interactive and mobile technology to manage alcohol use problem potentially provide continuing care by offering emotional and instrumental support anywhere and in time, but the effectiveness for maintaining abstinence has not been examined. the investigators will evaluate in this study whether the smartphone-based support system would improve outcomes for people in recovery for alcohol dependence. To enable continuous self-monitoring and self-management, the phone support system prompts subjects to take Breath Alcohol Concentration (BrAC) tests using a phone application and a Bluetooth sensor unit. The system also offers instantaneous feedback, self-management strategies, and anonymous mutual social support from other subjects.
Methods: This three-year project will be conducted in three stages, including pilot study, efficacy evaluation (12 week), and post-intervention follow-up (12 week) stage. Participants will be given a smartphone (if the subject does not have one), breathalyzer and training session. In the pilot study stage,10 subjects will be enrolled to validate the system. In the efficacy evaluation stage, the investigators will conduct a 12-week by enrolling 100 post-detoxification alcohol dependent patients who are randomized to (1) standard treatment (ST) group or (2) standard treatment plus phone-based support group (technology intervention, TI group). Participants will be assessed by Time-Line Follow-Back (TLFB) to record the frequency and quantity of alcohol consumption, visual analogue for craving, Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI), Satisfaction with Life Scale (SWLS), and Quality of life Scale (WHOQOL-BREF) and compared for outcome measures. After the 12-week trial, the investigators will take back the support system and follow the all subjects in both groups for another 12 weeks, i.e. post-intervention stage, to further understand the sustaining benefit from intervention. In addition, the investigators will identify the clinical variables or system factors that are associated with outcome measures.
Expected results: In this study, the investigators expect that in treatment-seeking alcohol dependent patients, a smartphone-supported self-management program, adding on to conventional treatment, will be beneficial in improving the drinking outcomes such as a higher abstinence rate, a lower relapse rate, and a lower drinking frequency and quantity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: SmartPhone Support SystemThis group of subjects receives mobile support system and conventional treatment |
| Control group | No intervention | –This group of patients receive conventional treatment only |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 20 and 50 years;
- Use an Android phone as his/her primary phone, or be willing to use an Android phone provided by National Taiwan University as his/her primary phone during the study;
- Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of alcohol dependence assessed by the Structured Clinical Interview;
- Complete abstinence for at least 10 days and free of any withdrawal symptoms; and
- Drug screening test results negative opiates, amphetamines, and ketamine.
Key exclusion criteria (8 listed)
- A current DSM-IV diagnosis of dependence or abuse on other substances except nicotine or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
- A current mental or psychiatric impairment or disease that required psychotropic medication or inpatient treatment on a psychiatric ward;
- A history of opioid or psychostimulant abuse;
- A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;
- Current use of any antipsychotics;
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 |
|---|---|---|
| SmartPhone Support System | Behavioural | Intervention group |
Primary outcome
Time to first lapse
Time frame: 12 weeks
Time to first relapse
Time frame: 12 weeks
Cumulative abstinence days
Time frame: 12 weeks
Number of drinks per drinking days
Time frame: 12 weeks
each visit during the 12 weeks: week 1, 2, 4, 8, 12
VAS craving measurement
Time frame: 12 weeks
each visit during the 12 weeks: week 1, 2, 4, 8, 12
complete abstinence rate
Time frame: 12 weeks
Drop-out rate
Time frame: 12 weeks
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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.
Ming-Chyi Huang, MD, PhD principal investigator
Taipei City Psychiatric Center
Hao-Hua Chu, PhD study chair
Department of Computer Science and Information Engineering, National Taiwan University
Chuang-Wen You, PhD study director
Intel-NTU Connected Context Computing Center, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartPhone Support System in people with Alcohol Dependence, run by Ming-Chyi Huang at 1 site in Taiwan.
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 8 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Chyi Huang, MD, PhD (+886-2-27263141 ext. 1219, mingchyihuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first lapse (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2015.