Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care

Study Overview
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Brief Summary
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The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.

Detailed Description
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The study is a 12-month open-label and randomised comparison between the control group receiving only conventional treatment and the intervention group receiving conventional treatment enhanced with TripleA. The studies have been designed to reflect as far as possible the conventional care for alcohol dependence. The TripleA product is intended to strengthen the existing methods used during the assessment phase, treatment phase and aftercare of alcohol dependence.

Official Title
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Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care

Conditions
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Alcoholism

Intervention / Treatment
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* Device: TripleA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in care at Addiction and Neuropsychiatry Uppsala University Hospital and at Nämndemansgården Uppsala 18 years or older Meets at least 2 of the criteria for addiction/substance syndrome according to Diagnostic and statistical manual of mental disorders-5 (DSM-5) Ability to understand and communicate in Swedish Ability to handle the technical equipment used in the study (alcoholometer and Smartphone) Access to a fixed place (living, place for sleeping, place where the phone can be charged Exclusion Criteria: Schizophrenia Substance syndrome related to other substances than alcohol and nicotin Lowered lung function (not able to reach acceptable expiration volume for the alcoholometer function) The patient is taken care of within the frame for The Act on Care of Addicts Not suitable to participate according to the Investigator Has not consumed any alcohol during the 4 weeks defined as baseline timeline follow back Normalized Carbohydrate Deficient Transferrin (CDT) and Phosphatidyl-Ethanol (PEth)-values in blood samples at visit 1

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional treatment and TripleA<br>Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver | Device: TripleA<br> <br> |
| No Intervention: Conventional treatment<br>Conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With no Heavy Drinking Days After 12 Months | Difference between the treatment arms in percentage of patients with no heavy drinking days during the 4-weeks period before the 12 months follow-up visit . | Four weeks period before the 12 months visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Sober Patients During the Period Before the 6 Months Visit | Difference in percentage of sober patients (zero drinks during one month reporting period) during the four weeks period before the 6 months visit. | The four weeks-period before the 6 months visit | 
| Percentage of Sober Patients Before the 12 Months Visit | Percentage of sober patients (zero drinks during one month reporting period) during the four weeks period before the 12 months visit. | The four weeks-period before the 12 months visit | 
| Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit | Number of drinks during the 4 weeks period before the baseline visit minus number of drinks during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking. | The four weeks-period before the baseline visit and before the 6 months visit | 
| Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit | Number of drinks during the 4 weeks period before the baseline visit minus number of drinks during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking. | The four weeks-period before the baseline visit and before the 12 months visit | 
| Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit | Number of heavy drinking days during the 4 weeks period before the baseline visit minus number of heavy drinking days during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking. | The four weeks-period before the baseline visit and before the 6 months visit | 
| Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit | Number of heavy drinking days during the 4 weeks period before the baseline visit minus number of heavy drinking days during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking. | The four weeks-period before the baseline visit and before the 12 months visit | 
| Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit | Number of sober days during the 4 weeks period before the baseline visit minus number of sober days during the 4 weeks period before the 6 months visit. A negative difference means a reduction in drinking. A positive difference means increased drinking. | The four weeks-period before the baseline visit and before the 6 months visit | 
| Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit | Number of sober days during the 4 weeks period before the baseline visit minus number of sober days during the 4 weeks period before the 12 months visit. A negative difference means a reduction in drinking. A positive difference means increased drinking. | The four weeks-period before the baseline visit and before the 12 months visit | 
| Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit | Number of standard glasses/drinks per drinking day during the 4 weeks period before the baseline visit minus number of standard glasses/drinks per drinking day during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking. | The four weeks-period before the baseline visit and before the 6 months visit | 
| Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit | Number of standard glasses/drinks per drinking day during the 4 weeks period before the baseline visit minus number of standard glasses/drinks per drinking day during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking. | The four weeks-period before the baseline visit and before the 12 months visit | 
| Time to Heavy Drinking | Time period in days from randomization to first heavy drinking day. Longer time means a better result. | From date of randomization until the date of first heavy drinking day, assessed up to 12 months | 
| Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D at the Baseline Visit Compared to the 6 Months Visit | Change in health outcome, measured with the visual analog scale (EQ VAS) in EQ-5D after 6 months compared to baseline. The EQ-5D is a standardized instrument for measuring and describing health outcomes. VAS score is 0-100 where 0 is the worst possible health and 100 is the best possible health. A positive difference indicates improvement. | Baseline, After 6 months | 
| Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D From the Baseline Visit Compared to the 12 Months Visit | Change in health outcome, measured with the visual analog scale (EQ VAS) in EQ-5D after12 months compared to baseline. The EQ-5D is a standardized instrument for measuring and describing health outcomes. VAS score is 0-100 where 0 is the worst possible health and 100 is the best possible health. A positive number indicates improvement. | Baseline, After 12 months | 
| Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline | Change in health outcome, measured with the questionnaire in EQ-5D after 6 months compared to baseline. The questionnaire EQ-5D in EQ-5D consists of 5 questions giving score 5 - 15. A higher positive number indicates improvement. | Baseline, After 6 months | 
| Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline | Change in health outcome, measured with the questionnaire in EQ-5D after 12 months minus baseline. The questionnaire EQ-5D in EQ-5D consists of 5 questions giving score 5 - 15. A higher positive number indicates improvement. | Baseline, After 12 months | 
| Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months | Percentage of patients who have reduced their AUDIT score (Alcohol Use Disorders Identification Test, score 0-40) after 12 months. Higher proportion is better. | After 12 months | 
| Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months | Percentage of patients who have reduced their Alcohol Use Disorders Identification Test (AUDIT) risk zones with at least one zone. Higher proportion is better. | After 12 months | 
| Percentage of Patients Having a Risk Level <II (i.e. Less Than 6 AUDIT Points for Women, 8 AUDIT Points for Men) After 12 Months | Percentage of patients having a risk level <II (i.e. less than Alcohol Use Disorders Identification Test (AUDIT) points, i.e. 6 points for women, 8 points for men) after 12 months. Higher proportion is better. | After 12 months | 
| Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months | Change in degree of alcohol dependence measured as the difference in Short Alcohol Dependence Data (SADD)-points at baseline minus 6 months Scoring: The 15 items summed for a total score than can range from 0 to 45. Scale totals are interpreted as follows: 1-9 low dependence, 10-19 medium dependence, and 20 or greater high dependence. A large positive number indicates a better result. | Baseline, After 6 months | 
| Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months | Change in degree of alcohol dependence measured as the difference in Short Alcohol Dependence Data (SADD)-points at baseline minus 12 months. Scoring: The 15 items summed for a total score than can range from 0 to 45. Scale totals are interpreted as follows: 1-9 low dependence, 10-19 medium dependence, and 20 or greater high dependence. A large positive number indicates a better result. | Baseline, After 12 months | 
| Compliance With Agreed Treatment | Percentage of subjects staying in the study to the 12 months visit. | Baseline, After 12 months | 
| Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit | Change in concentration of the alcohol metabolite PEth at baseline minus 6 months. A larger positive change of PEth concentration is a better outcome. | Baseline, After 6 months | 
| Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months | Change in concentration of the alcohol metabolite PEth at baseline minus 12 months. A larger positive change of PEth concentration is a better outcome. | Baseline, After 12 months | 
| Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months | CDT (Carbohydrate Deficient Transferrin) concentration is given in % of total transferrin in serum, i e. CDT(%). The change is calculated as baseline CDT (%) minus CDT(%) at 6 months. A large positive difference indicates decreased drinking. | Baseline, After 6 months | 
| Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months | CDT (Carbohydrate Deficient Transferrin) concentration is given in % of total transferrin in serum, i e. CDT(%). The change is calculated as baseline CDT (%) minus CDT(%) at 12 months. A large positive difference indicates decreased drinking. | Baseline, After 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol abuse, Alcoholometer, Medical Device, App