AlcoholismNCT03195894
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
A study testing TripleA in people with Alcoholism, run by Kontigo Care AB.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- TripleA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare 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.
Read the detailed 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.
- Conditions
- Alcoholism
- Being tested
- TripleA
- Keywords
- Alcohol abuse, Alcoholometer, Medical Device, App
- Medical subject headings
- Alcoholism, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TripleADevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TripleA |
| Conventional treatment | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Four weeks period before the 12 months visit
Secondary outcomes (25)
Percentage of Sober Patients During the 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.
Measured: The four weeks-period before the 6 months visit
Percentage of Sober Patients 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: The four weeks-period before the baseline visit and before the 6 months visit
Change in Heavy Alcohol Drinking Days From the Baseline Visit to 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.
Measured: The four weeks-period before the baseline visit and before the 12 months visit
Change in Number of Sober Days Before the Baseline Visit Compared to 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.
Measured: The four weeks-period before the baseline visit and before the 6 months visit
Change in Number of Sober Days Before the Baseline Visit Compared to 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.
Measured: The four weeks-period before the baseline visit and before the 12 months visit
Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to 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.
Measured: The four weeks-period before the baseline visit and before the 6 months visit
Change in Number of Standard Glasses Before the Baseline Visit Comapred to 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.
Measured: The four weeks-period before the baseline visit and before the 12 months visit
Time to Heavy Drinking
Time period in days from randomization to first heavy drinking day. Longer time means a better result.
Measured: From date of randomization until the date of first heavy drinking day, assessed up to 12 months
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
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.
Measured: Baseline, After 6 months
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
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.
Measured: Baseline, After 12 months
Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline
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.
Measured: Baseline, After 6 months
Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline
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.
Measured: Baseline, After 12 months
Percentage of Patients Who Have Reduced Their AUDIT Score 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.
Measured: After 12 months
Percentage of Patients With Lowered AUDIT Score With at Least One Zone 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.
Measured: After 12 months
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
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.
Measured: After 12 months
Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 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.
Measured: Baseline, After 6 months
Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 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.
Measured: Baseline, After 12 months
Compliance With Agreed Treatment
Percentage of subjects staying in the study to the 12 months visit.
Measured: Baseline, After 12 months
Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit
Change in concentration of the alcohol metabolite PEth at baseline minus 6 months. A larger positive change of PEth concentration is a better outcome.
Measured: Baseline, After 6 months
Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 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.
Measured: Baseline, After 12 months
Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 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.
Measured: Baseline, After 6 months
Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 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.
Measured: Baseline, After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Oct 2015
- Primary completion15 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kontigo Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
- Investigators
- Tobias Eriksson, MD PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195894
- Sponsor's protocol ID
- KC102-001/KC102-002
- Status last verified
- Nov 2021
- First submitted
- 11 May 2017
- Last updated
- 13 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29590325
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care
- ClinicalTrials.gov ID
- NCT03195894
- Acronym / sponsor ID
- KC102-001/KC102-002
- Conditions
- Alcoholism
- Keywords
- Alcohol abuse, Alcoholometer, Medical Device, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Kontigo Care ABIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala University
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 13 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment and TripleA | Experimental | Device: TripleAConventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver |
| Conventional treatment | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TripleA | Device | Conventional treatment and TripleA |
Primary outcome
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 .
25 secondary outcomes
Percentage of Sober Patients During the Period Before the 6 Months Visit
Time frame: The four weeks-period before the 6 months visit
Percentage of Sober Patients Before the 12 Months Visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The four weeks-period before the baseline visit and before the 6 months visit
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
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
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
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
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
Time to Heavy Drinking
Time frame: From date of randomization until the date of first heavy drinking day, assessed up to 12 months
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 From the Baseline Visit Compared to the 12 Months Visit
Time frame: Baseline, After 12 months
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 12 Months Compared to Baseline
Time frame: Baseline, After 12 months
Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months
Time frame: After 12 months
Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months
Time frame: After 12 months
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
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 SADD-points at Baseline Compared to 12 Months
Time frame: Baseline, After 12 months
Compliance With Agreed Treatment
Time frame: Baseline, After 12 months
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 Compared to 12 Months
Time frame: Baseline, After 12 months
Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months
Time frame: Baseline, After 6 months
Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months
Time frame: Baseline, After 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29590325Hamalainen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Eriksson, MD PhD principal investigator
Uppsala University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TripleA in people with Alcoholism, run by Kontigo Care AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With no Heavy Drinking Days After 12 Months (time frame: Four weeks period before the 12 months visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.