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

NCT ID: NCT03195894

Last Updated: 2021-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Alcoholism

Keywords

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Alcohol abuse, Alcoholometer, Medical Device, App

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

TripleA

Intervention Type DEVICE

Conventional treatment

Conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TripleA

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Kontigo Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Eriksson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

References

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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.

Reference Type DERIVED
PMID: 29590325 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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KC102-001/KC102-002

Identifier Type: -

Identifier Source: org_study_id