The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients

Alcohol Dependence Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385643
• Other study ID #: MOST 103-2628-B-532 -001 -MY3
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2015
• Last updated: March 5, 2015
• Start date: September 2013
• Est. completion date: July 2017

Study information

• Verified date: March 2015
• Source: Taipei City Hospital
• Contact: Ming-Chyi Huang, MD, PhD
• Phone: +886-2-27263141
• Email: mingchyihuang[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 20 and 50 years;

2. 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;

3. Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of alcohol dependence assessed by the Structured Clinical Interview;

4. Complete abstinence for at least 10 days and free of any withdrawal symptoms; and

5. Drug screening test results negative opiates, amphetamines, and ketamine.

Exclusion Criteria:

1. 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;

2. A current mental or psychiatric impairment or disease that required psychotropic medication or inpatient treatment on a psychiatric ward;

3. A history of opioid or psychostimulant abuse;

4. A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;

5. Current use of any antipsychotics;

6. Homelessness;

7. Pregnancy, nursing, or refusal to use a reliable method of birth control in women;

8. Cognitive deficit and not thus being able to comprehend the informed consent and study procedure

Study Design

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• SmartPhone Support System

Locations

Country	Name	City	State
Taiwan	Ming-Chyi	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Ming-Chyi Huang

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first lapse		12 weeks	No
Primary	Time to first relapse		12 weeks	No
Primary	Cumulative abstinence days		12 weeks	No
Primary	Number of drinks per drinking days	each visit during the 12 weeks: week 1, 2, 4, 8, 12	12 weeks	No
Primary	VAS craving measurement	each visit during the 12 weeks: week 1, 2, 4, 8, 12	12 weeks	No
Primary	complete abstinence rate		12 weeks	No
Primary	Drop-out rate	each visit during the 12 weeks: week 1, 2, 4, 8, 12	12 weeks	No