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

Not Applicable

Completed

Conditions: Alcoholism

Interventions: Device: TripleA

Registration Number: NCT03195894

Lead Sponsor: Kontigo Care AB

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment and TripleA	TripleA	Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With no Heavy Drinking Days After 12 Months	Four weeks period before the 12 months visit	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 .

Secondary Outcome Measures

Name	Time	Method
Percentage of Sober Patients During the Period Before the 6 Months Visit	The four weeks-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.
Percentage of Sober Patients Before the 12 Months Visit	The four weeks-period 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.
Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit	The four weeks-period before the baseline visit and before 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.
Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit	The four weeks-period before the baseline visit and before the 12 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.
Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit	The four weeks-period before the baseline visit and before 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.
Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit	The four weeks-period before the baseline visit and before 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.
Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit	The four weeks-period before the baseline visit and before 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.
Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit	The four weeks-period before the baseline visit and 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.
Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit	The four weeks-period before the baseline visit and 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.
Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit	The four weeks-period before the baseline visit and 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.
Time to Heavy Drinking	From date of randomization until the date of first heavy drinking day, assessed up to 12 months	Time period in days from randomization to first heavy drinking day. Longer time means a better result.
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	Baseline, After 6 months	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.
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	Baseline, After 12 months	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.
Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline	Baseline, After 6 months	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.
Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline	Baseline, After 12 months	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.
Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months	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.
Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months	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.
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	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.
Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months	Baseline, After 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.
Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit	Baseline, After 6 months	Change in concentration of the alcohol metabolite PEth at baseline minus 6 months. A larger positive change of PEth concentration is a better outcome.
Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months	Baseline, After 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.
Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months	Baseline, After 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.
Compliance With Agreed Treatment	Baseline, After 12 months	Percentage of subjects staying in the study to the 12 months visit.
Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months	Baseline, After 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.
Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months	Baseline, After 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.