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

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TripleA
Sponsored by
Kontigo Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Alcoholism focused on measuring Alcohol abuse, Alcoholometer, Medical Device, App

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Conventional treatment and TripleA

    Conventional treatment

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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 .

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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 to Heavy Drinking
    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
    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
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Compliance With Agreed Treatment
    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
    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
    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
    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
    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.

    Full Information

    First Posted
    May 11, 2017
    Last Updated
    December 9, 2021
    Sponsor
    Kontigo Care AB
    Collaborators
    Uppsala University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03195894
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    February 15, 2018 (Actual)
    Study Completion Date
    March 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kontigo Care AB
    Collaborators
    Uppsala University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcoholism
    Keywords
    Alcohol abuse, Alcoholometer, Medical Device, App

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional treatment and TripleA
    Arm Type
    Experimental
    Arm Description
    Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver
    Arm Title
    Conventional treatment
    Arm Type
    No Intervention
    Arm Description
    Conventional treatment
    Intervention Type
    Device
    Intervention Name(s)
    TripleA
    Primary Outcome Measure Information:
    Title
    Percentage of Patients With no Heavy Drinking Days After 12 Months
    Description
    Difference between the treatment arms in percentage of patients with no heavy drinking days during the 4-weeks period before the 12 months follow-up visit .
    Time Frame
    Four weeks period before the 12 months visit
    Secondary Outcome Measure Information:
    Title
    Percentage of Sober Patients During the Period Before the 6 Months Visit
    Description
    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
    Title
    Percentage of Sober Patients Before the 12 Months Visit
    Description
    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
    Title
    Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit
    Description
    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
    Title
    Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit
    Description
    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
    Title
    Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit
    Description
    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
    Title
    Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit
    Description
    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
    Title
    Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit
    Description
    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
    Title
    Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit
    Description
    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
    Title
    Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit
    Description
    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
    Title
    Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit
    Description
    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
    Title
    Time to Heavy Drinking
    Description
    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
    Title
    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
    Description
    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
    Title
    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
    Description
    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
    Title
    Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline
    Description
    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
    Title
    Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline
    Description
    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
    Title
    Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months
    Description
    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
    Title
    Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months
    Description
    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
    Title
    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
    Description
    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
    Title
    Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months
    Description
    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
    Title
    Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months
    Description
    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
    Title
    Compliance With Agreed Treatment
    Description
    Percentage of subjects staying in the study to the 12 months visit.
    Time Frame
    Baseline, After 12 months
    Title
    Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit
    Description
    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
    Title
    Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months
    Description
    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
    Title
    Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months
    Description
    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
    Title
    Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tobias Eriksson, MD PhD
    Organizational Affiliation
    Uppsala University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29590325
    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. Erratum In: Alcohol Alcohol. 2018 Jul 1;53(4):499.
    Results Reference
    derived

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

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