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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195894
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Kontigo Care AB

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.

Condition or disease Intervention/treatment Phase
Alcoholism Device: TripleA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care
Actual Study Start Date : November 8, 2015
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: TripleA
No Intervention: Conventional treatment
Conventional treatment



Primary Outcome Measures :
  1. Difference in heavy alcohol drinking days [ Time Frame: The four weeks-period before the 12 months visit ]
    Difference in number of heavy alcohol drinking Days between the treatment arms


Secondary Outcome Measures :
  1. Difference in number of sober patients [ Time Frame: The four weeks-period before the 6 months visit ]
    Difference in number of sober patients between the treatment arms

  2. Difference in number of sober patients [ Time Frame: The four weeks-period before the 12 months visit ]
    Difference in number of sober patients between the treatment arms

  3. Difference in total amount of consumed alcohol [ Time Frame: The four weeks-period before the 6 months visit ]
    Difference in total amount of consumed alcohol compared to baseline

  4. Difference in total amount of consumed alcohol [ Time Frame: The four weeks-period before the 12 months visit ]
    Difference in total amount of consumed alcohol compared to baseline

  5. Difference in heavy alcohol drinking days [ Time Frame: The four weeks-period before the 6 months visit ]
    Difference in heavy alcohol drinking days compared to baseline

  6. Difference in heavy alcohol drinking days [ Time Frame: The four weeks-period before the 12 months visit ]
    Difference in heavy alcohol drinking days compared to baseline

  7. Difference in alcohol-free days [ Time Frame: The four weeks-period before the 6 months visit ]
    Difference in alcohol-free days compared to baseline

  8. Difference in alcohol-free days [ Time Frame: The four weeks-period before the 12 months visit ]
    Difference in alcohol-free days compared to baseline

  9. Difference in number of standard glasses [ Time Frame: The four weeks-period before the 6 months visit ]
    Difference in number of standard glasses compared to baseline

  10. Difference in number of standard glasses [ Time Frame: The four weeks-period before the 12 months visit ]
    Difference in number of standard glasses compared to baseline

  11. Time to relapse [ Time Frame: From date of randomization until the date of first relapse of drinking alcohol, assessed up to 12 months ]
    Time period

  12. Improvement of Clinical Global Impression [ Time Frame: After 6 months ]
    Improvement

  13. Improvement of Clinical Global Impression [ Time Frame: After 12 months ]
    Improvement

  14. Change in health [ Time Frame: After 12 months ]
    Measured by EQ-5D

  15. Number of patients with lowered AUDIT score [ Time Frame: After 12 months ]
    Number of patients

  16. Number of patients with lowered AUDIT score with at least one zone [ Time Frame: After 12 months ]
    Number of patients

  17. Number of patients with a risk level II [ Time Frame: After 12 months ]
    Less than 6 AUDIT points for women and 8 AUDIT points for men

  18. Change in level of alcohol addiction [ Time Frame: After 6 months ]
    Measured as the difference in SADD points compared to baseline

  19. Change in level of alcohol addiction [ Time Frame: After 12 months ]
    Measured as the difference in SADD points compared to baseline

  20. Treatment compliance [ Time Frame: After 6 months ]
    Change in blood concentrations of the alcohol metabolitesPEth and CDT compared to baseline

  21. Treatment compliance [ Time Frame: After 12 months ]
    Change in blood concentrations of the alcohol metabolitesPEth and CDT compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in care at Addiction and Neuropsychiatry Uppsala University Hospital and at Nämndemansgården, Jälla, 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 Lagen om Vård av Missbrukare, LVM (Care of addicts regulations)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195894


Sponsors and Collaborators
Kontigo Care AB
Uppsala University
Investigators
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Principal Investigator: Tobias Eriksson, MD PhD Uppsala University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kontigo Care AB
ClinicalTrials.gov Identifier: NCT03195894    
Other Study ID Numbers: KC102-001/KC102-002
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kontigo Care AB:
Alcohol abuse, Alcoholometer, Medical Device, App
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs