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Completed

NCT Number: NCT03195894

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

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Alzheimer Disease Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Substance-Related Disorders Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TripleA

Device

Primary outcomes

  1. Percentage of Patients With no Heavy Drinking Days After 12 Months

    Time frame: Four weeks period before the 12 months visit

    Difference between the treatment arms in percentage of patients with no heavy drinking days during the 4-weeks period before the 12 months follow-up visit .

Secondary outcomes

  1. Percentage of Sober Patients During the Period Before the 6 Months Visit

    Time frame: 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.

  2. Percentage of Sober Patients Before the 12 Months Visit

    Time frame: 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.

  3. Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit

    Time frame: 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.

  4. Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit

    Time frame: 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.

  5. Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit

    Time frame: 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.

  6. Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit

    Time frame: 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.

  7. Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit

    Time frame: 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.

  8. Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit

    Time frame: 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.

  9. Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit

    Time frame: 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.

  10. Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit

    Time frame: 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.

  11. Time to Heavy Drinking

    Time frame: 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.

  12. 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

    Time frame: 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.

  13. 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

    Time frame: 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.

  14. Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline

    Time frame: 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.

  15. Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline

    Time frame: 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.

  16. Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months

    Time frame: 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.

  17. Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months

    Time frame: 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.

  18. 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

    Time frame: 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.

  19. Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months

    Time frame: 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.

  20. Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months

    Time frame: 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.

  21. Compliance With Agreed Treatment

    Time frame: Baseline, After 12 months

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

  22. Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit

    Time frame: 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.

  23. Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months

    Time frame: 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.

  24. Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months

    Time frame: 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.

  25. Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kontigo Care AB

Industry

Collaborators

  • Uppsala University

Registry information

Official study title

Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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