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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment and TripleA | Experimental | Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver |
|
| Conventional treatment | No Intervention | Conventional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TripleA | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Eriksson, MD PhD | Uppsala University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29590325 | Derived | Hamalainen MD, Zetterstrom A, Winkvist M, Soderquist M, Karlberg E, Ohagen P, Andersson K, Nyberg F. Real-time Monitoring using a breathalyzer-based eHealth system can identify lapse/relapse patterns in alcohol use disorder Patients. Alcohol Alcohol. 2018 Jul 1;53(4):368-375. doi: 10.1093/alcalc/agy011. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Conventional Treatment | Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients (n=115) were recruited to clinical trials from a 12-step aftercare programme(12S-ABS) and from hospital care with abstinence (HC-ABS) or controlled drinking (HC-CDR) as goal. The subject population for study KC102-001 was formed by 71 subjects enrolled at Uppsala University Hospital. Study KC102-002 included 44 subjects registered at Nämndemansgårdens treatment home.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Conventional Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 . | 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. | Posted | Count of Participants | Participants | Four weeks period before the 12 months visit |
|
Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | Non-systematic Assessment | Ascites due to liver cirrhosis. Not related to device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold, fever, flu | Infections and infestations | Non-systematic Assessment | Five patients reported cold, or flu-like symptoms and fever. |
Due to unrealistic assumptions in the sample size calculations, difficulties in recruiting subjects and high dropout rate, the study was inconclusive.
The poor recruitment rate and poor retention of patients in the study was a challenge (in addition with the quality of self-reported outcomes). The drop-out rate, especially between month 6-12, was a problem both in treatment and control groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Markku Hämäläinen, Research Director | KontigoCare AB | 0769 47 31 32 | markku.hamalainen@kontigocare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2015 | Aug 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
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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 \ | 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 |
| Lost to Follow-up |
|
Conventional treatment which is medication or a 12-step addiction treatment according to the Minnesota model. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Conventional treatment only. |
|
|
| 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. | Posted | Count of Participants | Participants | The four weeks-period before the 6 months visit |
|
|
|
| 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. | Posted | Count of Participants | Participants | The four weeks-period before the 12 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Number of drinks | The four weeks-period before the baseline visit and before the 6 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Number of drinks | The four weeks-period before the baseline visit and before the 12 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Number of heavy drinking days | The four weeks-period before the baseline visit and before the 6 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Number of heavy drinking days | The four weeks-period before the baseline visit and before the 12 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Difference in number of sober days | The four weeks-period before the baseline visit and before the 6 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Difference in number of sober days | The four weeks-period before the baseline visit and before the 12 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Average no of glasses per drinking day | The four weeks-period before the baseline visit and before the 6 months visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Average no of glasses per drinking day | The four weeks-period before the baseline visit and before the 12 months visit |
|
|
|
| Secondary | Time to Heavy Drinking | Time period in days from randomization to first heavy drinking day. Longer time means a better result. | Posted | Mean | Standard Deviation | Days | From date of randomization until the date of first heavy drinking day, assessed up to 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, After 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, After 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, After 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, After 12 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | After 12 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | After 12 months |
|
|
|
| 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 \ | Posted | Count of Participants | Participants | After 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Difference in SADD-points | Baseline, After 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Difference in SADD-points | Baseline, After 12 months |
|
|
|
| Secondary | Compliance With Agreed Treatment | Percentage of subjects staying in the study to the 12 months visit. | Posted | Count of Participants | Participants | Baseline, After 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | umol/L | Baseline, After 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | umol/L | Baseline, After 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage CDT of total transferrin | Baseline, After 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage CDT of total transferrin | Baseline, After 12 months |
|
|
|
| 0 |
| 59 |
| 12 |
| 59 |
| 5 |
| 59 |
| EG001 | Conventional Treatment | Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment | 0 | 56 | 6 | 56 | 4 | 56 |
|
| Bleeding | Gastrointestinal disorders | Non-systematic Assessment | Bleeding esophagusvarices and duodenal ulcus. Not related to device. |
|
| Sepsis | Blood and lymphatic system disorders | Non-systematic Assessment | Staphylococcus aureus sepsis. Not related to device. |
|
| Abstinence | Psychiatric disorders | Non-systematic Assessment | Hospitalization due to alcohol abstinence. Not related to device. |
|
| Fainting, dizziness and nausea | General disorders | Non-systematic Assessment | Not related to device. |
|
| Suspected transient ischemic attack (TIA) | Vascular disorders | Non-systematic Assessment | Not related to device. |
|
| Infection in foot | Infections and infestations | Non-systematic Assessment | Infection in foot after surgery. Not related to device. |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Not related to device. |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment | Not related to device. |
|
| Alcohol intoxication | General disorders | Non-systematic Assessment | Intoxication, lowered consciousness and delirium. Not related to device. |
|
| Suicide attempts | Psychiatric disorders | Non-systematic Assessment | Not related to device. |
|
| Recurrent ischemic pain | Vascular disorders | Non-systematic Assessment | Not related to device |
|
| Myocardial Infarction | Vascular disorders | Non-systematic Assessment |
|
|
| Pain | General disorders | Non-systematic Assessment | Four patients reported pain in foot, hand, or thumb. |
|
Not provided
Not provided
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |