Alcoholism
Conditions
Keywords
Alcohol abuse, Alcoholometer, Medical Device, App
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.
Interventions
DEVICETripleA
Sponsors
Uppsala University
Kontigo Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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 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 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. |
| 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. |
Participant flow
Recruitment details
Patients were recruited at two sites (Uppsala University Hospital and Nämndemansgården) beginning in October 2015 . Recruitment continued until January 2017 and the last follow-up visits were conducted in December 2017 (Uppsala University Hospital) and in January 2018 (Nämndemansgården), respectively.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Treatment and TripleA Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA. | 59 |
| Conventional Treatment Conventional treatment which is medication or a 12-step addiction treatment according to the Minnesota model. | 56 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | An example is Started other treatment. | 4 | 5 |
| Overall Study | Lost to Follow-up | 14 | 19 |
| Overall Study | Withdrawal by Subject | 15 | 4 |
Baseline characteristics
| Characteristic | Conventional Treatment | Total | Conventional Treatment and TripleA |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 9.63 | 53.4 years STANDARD_DEVIATION 8.9 | 53.1 years STANDARD_DEVIATION 8.16 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 56 participants | 115 participants | 59 participants |
| Sex: Female, Male Female | 17 Participants | 39 Participants | 22 Participants |
| Sex: Female, Male Male | 39 Participants | 76 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 56 |
| other Total, other adverse events | 5 / 59 | 4 / 56 |
| serious Total, serious adverse events | 12 / 59 | 6 / 56 |
Outcome results
Primary
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
Population: Of the planned patient number (216 patients) only approximately 25% or less was analyzed due to poor recruitment rate and a high drop-out of patients during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | Percentage of Patients With no Heavy Drinking Days After 12 Months | 8 Participants |
| Conventional Treatment | Percentage of Patients With no Heavy Drinking Days After 12 Months | 9 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months | 0.18 percentage CDT of total transferrin | Standard Deviation 0.7 |
| Conventional Treatment | Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months | 0.25 percentage CDT of total transferrin | Standard Deviation 0.74 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months | 0.11 percentage CDT of total transferrin | Standard Deviation 0.55 |
| Conventional Treatment | Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months | 0.42 percentage CDT of total transferrin | Standard Deviation 0.94 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months | 0.53 umol/L | Standard Deviation 0.86 |
| Conventional Treatment | Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months | 0.18 umol/L | Standard Deviation 0.37 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit | 0.20 umol/L | Standard Deviation 0.61 |
| Conventional Treatment | Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit | 0.33 umol/L | Standard Deviation 0.85 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months | 17.00 Difference in SADD-points | Standard Deviation 10.56 |
| Conventional Treatment | Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months | 11.19 Difference in SADD-points | Standard Deviation 9.17 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months | 15.39 Difference in SADD-points | Standard Deviation 9.53 |
| Conventional Treatment | Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months | 11.76 Difference in SADD-points | Standard Deviation 9.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline | -0.04 score on a scale | Standard Deviation 1.37 |
| Conventional Treatment | Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline | 0.32 score on a scale | Standard Deviation 0.98 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline | 0.16 score on a scale | Standard Deviation 1.41 |
| Conventional Treatment | Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline | 0.08 score on a scale | Standard Deviation 1.12 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | 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 | 9.84 Score on a scale | Standard Deviation 21.52 |
| Conventional Treatment | 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 | 6.27 Score on a scale | Standard Deviation 22.28 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | 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 | 6.23 score on a scale | Standard Deviation 22.07 |
| Conventional Treatment | 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 | 8.18 score on a scale | Standard Deviation 20.43 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit | 14.65 Number of heavy drinking days | Standard Deviation 10.61 |
| Conventional Treatment | Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit | 13.54 Number of heavy drinking days | Standard Deviation 10.23 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit | 15.21 Number of heavy drinking days | Standard Deviation 10.79 |
| Conventional Treatment | Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit | 14.41 Number of heavy drinking days | Standard Deviation 10.02 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit | -14.38 Difference in number of sober days | Standard Deviation 9.8 |
| Conventional Treatment | Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit | -13.04 Difference in number of sober days | Standard Deviation 11.97 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit | -15.87 Difference in number of sober days | Standard Deviation 10.11 |
| Conventional Treatment | Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit | -15.35 Difference in number of sober days | Standard Deviation 10.58 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit | 8.52 Average no of glasses per drinking day | Standard Deviation 6.61 |
| Conventional Treatment | Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit | 7.03 Average no of glasses per drinking day | Standard Deviation 6.37 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit | 7.70 Average no of glasses per drinking day | Standard Deviation 5.73 |
| Conventional Treatment | Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit | 7.36 Average no of glasses per drinking day | Standard Deviation 7.62 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit | 195.02 Number of drinks | Standard Deviation 170.29 |
| Conventional Treatment | Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit | 150.93 Number of drinks | Standard Deviation 164.09 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit | 183.7 Number of drinks | Standard Deviation 147.27 |
| Conventional Treatment | Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit | 180.62 Number of drinks | Standard Deviation 187.91 |
Secondary
Compliance With Agreed Treatment
Percentage of subjects staying in the study to the 12 months visit.
Time frame: Baseline, After 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | Compliance With Agreed Treatment | 26 Participants |
| Conventional Treatment | Compliance With Agreed Treatment | 28 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | 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 | 13 Participants |
| Conventional Treatment | 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 | 9 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months | 24 Participants |
| Conventional Treatment | Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months | 24 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months | 21 Participants |
| Conventional Treatment | Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months | 23 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | Percentage of Sober Patients Before the 12 Months Visit | 15 Participants |
| Conventional Treatment | Percentage of Sober Patients Before the 12 Months Visit | 14 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Treatment and TripleA | Percentage of Sober Patients During the Period Before the 6 Months Visit | 24 Participants |
| Conventional Treatment | Percentage of Sober Patients During the Period Before the 6 Months Visit | 21 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Treatment and TripleA | Time to Heavy Drinking | 187.3 Days | Standard Deviation 139.3 |
| Conventional Treatment | Time to Heavy Drinking | 141.2 Days | Standard Deviation 134.6 |