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

Kontigo Care

Status: Completed

Conditions: Alcoholism

Treatments: Device: TripleA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03195894

KC102-001/KC102-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Conventional treatment and TripleA

Experimental group

Description:

Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver

Treatment:

Device: TripleA

Conventional treatment

No Intervention group

Description:

Conventional treatment