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

NCT03195894 | Completed Results

• 1 other identifier: KC102-001/KC102-002
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholism

Keywords

Alcohol abuse, Alcoholometer, Medical Device, App

Outcome Measures

Primary Outcomes (1)

• 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 .

  Four weeks period before the 12 months visit

Secondary Outcomes (25)

• Percentage of Sober Patients During the Period Before the 6 Months Visit

  The four weeks-period before the 6 months visit

• Percentage of Sober Patients Before the 12 Months Visit

  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

  The four weeks-period before the baseline visit and before the 6 months visit

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

  The four weeks-period before the baseline visit and before the 12 months visit

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

  The four weeks-period before the baseline visit and before the 6 months visit

Study Arms (2)

Conventional treatment and TripleA

EXPERIMENTAL

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

Conventional treatment

NO INTERVENTION

Conventional treatment

Interventions

TripleA DEVICE

Conventional treatment and TripleA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in care at Addiction and Neuropsychiatry Uppsala University Hospital and at Nämndemansgården Uppsala
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kontigo Care AB: lead
• Uppsala University: collaborator

Related Publications (1)

• 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.

  PMID: 29590325 DERIVED

MeSH Terms

Conditions

Alcoholism; Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Due to unrealistic assumptions in the sample size calculations, difficulties in recruiting subjects and high dropout rate, the study was inconclusive. The poor recruitment rate and poor retention of patients in the study was a challenge (in addition with the quality of self-reported outcomes). The drop-out rate, especially between month 6-12, was a problem both in treatment and control groups.

Results Point of Contact

• Title: Markku Hämäläinen, Research Director
• Organization: KontigoCare AB

markku.hamalainen@kontigocare.com

0769 47 31 32

Study Officials

• Tobias Eriksson, MD PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: June 22, 2017
• Study Start: October 1, 2015
• Primary Completion: February 15, 2018
• Study Completion: March 1, 2018
• Last Updated: December 13, 2021
• Results First Posted: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share