N/A
Completed N=115
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
Alcoholism
Source: ClinicalTrials.gov NCT03195894 ↗
Enrolled (actual)
115
Serious AEs
15.7%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Patients With no Heavy Drinking Days After 12 Months — 8; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With no Heavy Drinking Days After 12 Months |
8; 9 | — |
| SECONDARY Percentage of Sober Patients During the Period Before the 6 Months Visit |
24; 21 | — |
| SECONDARY Percentage of Sober Patients Before the 12 Months Visit |
15; 14 | — |
| SECONDARY Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit |
183.7; 180.62 | — |
| SECONDARY Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit |
195.02; 150.93 | — |
| SECONDARY Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit |
15.21; 14.41 | — |
| SECONDARY Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit |
14.65; 13.54 | — |
| SECONDARY Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit |
-15.87; -15.35 | — |
| SECONDARY Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit |
-14.38; -13.04 | — |
| SECONDARY Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit |
7.70; 7.36 | — |
| SECONDARY Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit |
8.52; 7.03 | — |
| SECONDARY Time to Heavy Drinking |
187.3; 141.2 | — |
| SECONDARY 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 |
9.84; 6.27 | — |
| SECONDARY 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 |
6.23; 8.18 | — |
| SECONDARY Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline |
0.16; 0.08 | — |
| SECONDARY Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline |
-0.04; 0.32 | — |
| SECONDARY Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months |
24; 24 | — |
| SECONDARY Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months |
21; 23 | — |
| SECONDARY 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 |
13; 9 | — |
| SECONDARY Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months |
15.39; 11.76 | — |
| SECONDARY Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months |
17.00; 11.19 | — |
| SECONDARY Compliance With Agreed Treatment |
26; 28 | — |
| SECONDARY Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit |
0.20; 0.33 | — |
| SECONDARY Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months |
0.53; 0.18 | — |
| SECONDARY Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months |
0.11; 0.42 | — |
| SECONDARY Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months |
0.18; 0.25 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03195894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.