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

N/ACompletedNCT03195894

Kontigo Care AB115 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

115

Conditions

Alcoholism

Interventions

TripleADEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 .

Time frame: Four weeks period before the 12 months visit

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: The four weeks-period before the baseline visit and before the 12 months visit

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, After 12 months

Compliance With Agreed Treatment

Percentage of subjects staying in the study to the 12 months visit.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, After 12 months