Clinical trial NCT03195894: Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
Official title: Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Alcohol abuse, Alcoholometer, Medical Device, App
Lead sponsor: Kontigo Care AB
Sponsor class: INDUSTRY
Collaborators: name: Uppsala University
First posted: 2017-06-22
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With no Heavy Drinking Days After 12 Months
timeFrame: Four weeks period before the 12 months visit
Secondary outcomes:
measure: Percentage of Sober Patients During the Period Before the 6 Months Visit
timeFrame: The four weeks-period before the 6 months visit
measure: Percentage of Sober Patients Before the 12 Months Visit
timeFrame: The four weeks-period before the 12 months visit
measure: Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 6 months visit
measure: Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 12 months visit
measure: Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 6 months visit
measure: Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 12 months visit
measure: Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 6 months visit
measure: Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 12 months visit
measure: Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 6 months visit
measure: Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit
timeFrame: The four weeks-period before the baseline visit and before the 12 months visit
measure: Time to Heavy Drinking
timeFrame: From date of randomization until the date of first heavy drinking day, assessed up to 12 months
measure: 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
timeFrame: Baseline, After 6 months
measure: 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
timeFrame: Baseline, After 12 months
measure: Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline
timeFrame: Baseline, After 6 months
measure: Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline
timeFrame: Baseline, After 12 months
measure: Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months
timeFrame: After 12 months
measure: Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months
timeFrame: After 12 months
measure: 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
timeFrame: After 12 months
measure: Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months
timeFrame: Baseline, After 6 months
measure: Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months
timeFrame: Baseline, After 12 months
measure: Compliance With Agreed Treatment
timeFrame: Baseline, After 12 months
measure: Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit
timeFrame: Baseline, After 6 months
measure: Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months
timeFrame: Baseline, After 12 months
measure: Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months
timeFrame: Baseline, After 6 months
measure: Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months
timeFrame: Baseline, After 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University Hospital
name: Tobias Eriksson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.