Trial Outcomes & Findings for Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care (NCT NCT03195894)

NCT ID: NCT03195894

Last Updated: 2021-12-13

Results Overview

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 .

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 115 participants
• Primary outcome timeframe: Four weeks period before the 12 months visit
• Results posted on: 2021-12-13

Participant Flow

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.

Participant milestones

Measure	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	Conventional Treatment Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.
Overall Study STARTED	59	56
Overall Study COMPLETED	26	28
Overall Study NOT COMPLETED	33	28

Reasons for withdrawal

Measure	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	Conventional Treatment Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.
Overall Study An example is "Started other treatment".	4	5
Overall Study Withdrawal by Subject	15	4
Overall Study Lost to Follow-up	14	19

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Conventional Treatment and TripleA n=59 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA.	Conventional Treatment n=56 Participants Conventional treatment which is medication or a 12-step addiction treatment according to the Minnesota model.	Total n=115 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 8.16 • n=59 Participants	53.8 years STANDARD_DEVIATION 9.63 • n=56 Participants	53.4 years STANDARD_DEVIATION 8.9 • n=115 Participants
Sex: Female, Male Female	22 Participants n=59 Participants	17 Participants n=56 Participants	39 Participants n=115 Participants
Sex: Female, Male Male	37 Participants n=59 Participants	39 Participants n=56 Participants	76 Participants n=115 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	59 participants n=59 Participants	56 participants n=56 Participants	115 participants n=115 Participants

PRIMARY outcome

Timeframe: 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.

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 .

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
Percentage of Patients With no Heavy Drinking Days After 12 Months	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
Percentage of Sober Patients During the Period Before the 6 Months Visit	24 Participants	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
Percentage of Sober Patients Before the 12 Months Visit	15 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	180.62 Number of drinks Standard Deviation 187.91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit	195.02 Number of drinks Standard Deviation 170.29	150.93 Number of drinks Standard Deviation 164.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	14.41 Number of heavy drinking days Standard Deviation 10.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
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	13.54 Number of heavy drinking days Standard Deviation 10.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	-15.35 Difference in number of sober days Standard Deviation 10.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
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 9.80	-13.04 Difference in number of sober days Standard Deviation 11.97

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	7.36 Average no of glasses per drinking day Standard Deviation 7.62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
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	7.03 Average no of glasses per drinking day Standard Deviation 6.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=59 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=56 Participants Conventional treatment only.
Time to Heavy Drinking	187.3 Days Standard Deviation 139.3	141.2 Days Standard Deviation 134.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=37 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	6.27 Score on a scale Standard Deviation 22.28

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
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	8.18 score on a scale Standard Deviation 20.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	0.08 score on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
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	0.32 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=25 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months	24 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=25 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months	21 Participants	23 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=28 Participants Conventional treatment only.
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	9 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=38 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=37 Participants Conventional treatment only.
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	11.76 Difference in SADD-points Standard Deviation 9.60

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=26 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=27 Participants Conventional treatment only.
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	11.19 Difference in SADD-points Standard Deviation 9.17

SECONDARY outcome

Timeframe: Baseline, After 12 months

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

Outcome measures

Measure	Conventional Treatment and TripleA n=59 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=56 Participants Conventional treatment only.
Compliance With Agreed Treatment	26 Participants	28 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=18 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=29 Participants Conventional treatment only.
Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit	0.20 umol/L Standard Deviation 0.61	0.33 umol/L Standard Deviation 0.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=12 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=25 Participants Conventional treatment only.
Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months	0.53 umol/L Standard Deviation 0.86	0.18 umol/L Standard Deviation 0.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=12 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=19 Participants Conventional treatment only.
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	0.42 percentage CDT of total transferrin Standard Deviation 0.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Conventional Treatment and TripleA n=8 Participants Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA	Conventional Treatment n=16 Participants Conventional treatment only.
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 0.70	0.25 percentage CDT of total transferrin Standard Deviation 0.74

Adverse Events

Conventional Treatment and TripleA

Serious events: 12 serious events

Other events: 5 other events

Deaths: 0 deaths

Conventional Treatment

Serious events: 6 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Conventional Treatment and TripleA n=59 participants at risk 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 n=56 participants at risk Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment
Gastrointestinal disorders Ascites	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Gastrointestinal disorders Bleeding	1.7% 1/59 • Number of events 2 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Blood and lymphatic system disorders Sepsis	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Psychiatric disorders Abstinence	10.2% 6/59 • Number of events 9 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	3.6% 2/56 • Number of events 2 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
General disorders Fainting, dizziness and nausea	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	1.8% 1/56 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Vascular disorders Suspected transient ischemic attack (TIA)	0.00% 0/59 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	1.8% 1/56 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Infections and infestations Infection in foot	0.00% 0/59 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	1.8% 1/56 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Infections and infestations Pneumonia	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
General disorders Alcohol intoxication	3.4% 2/59 • Number of events 2 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Psychiatric disorders Suicide attempts	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Vascular disorders Recurrent ischemic pain	1.7% 1/59 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	0.00% 0/56 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
Vascular disorders Myocardial Infarction	0.00% 0/59 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	1.8% 1/56 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).

Other adverse events

Measure	Conventional Treatment and TripleA n=59 participants at risk 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 n=56 participants at risk Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment
Infections and infestations Cold, fever, flu	3.4% 2/59 • Number of events 3 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	5.4% 3/56 • Number of events 3 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).
General disorders Pain	5.1% 3/59 • Number of events 3 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).	1.8% 1/56 • Number of events 1 • Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).

Additional Information

Markku Hämäläinen, Research Director

KontigoCare AB

Phone: 0769 47 31 32

Email: markku.hamalainen@kontigocare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place