Trial · NCT04167306
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | B-PEth: Objective marker for alcohol consumption measured in blood, measured at every study visit. Analysed as mean reduction of PEth per treatment arm, mITT. |
| Primary | Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | Number of HDD by 14 days is defined as a mean over the 8-week steady state active treatment period (Day 21-Day77) . ( D21-D77)/4 in order to get a 14 day-period measurment. | HDD is obtained by the time Line Follow Back procedure, defined as ≥70 grams for men and ≥56 grams for women according to FDA's guidelines. Analysed as mean reduction in HDD share per treatment arm, for mITT |
| Secondary | CDT | CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | The indirect alcohol marker carbohydrate deficient transferrin |
| Secondary | GGT | GGT calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | The indirect alcohol marker gamma glutamyl transferase |
| Secondary | Self-reported Alcohol Consumption Measured by Time-lime-follow-back | CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | Mean grams of alcohol per day * Number of drinking days * Number of drinks per drinking days * Number of abstaining days |
| Secondary | Alcohol Use Identification Test | Mean difference between total score obtained at baseline and visit 1 | Total score of Alcohol Use Identification Test |
| Secondary | Self-reported Alcohol Craving | Scale range: 0-100 mm. Minimum value: 0 = No craving. Maxumum value: 100 Maximum= Very strong craving. Craving is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | Alcohol craving as measured by a Visual Analogue Scale (VAS) |
| Secondary | Nicotine Use | 77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77 | Nicotine use measured by the nicotine saliva marker cotinine in saliva |
| Secondary | The Temporal Experience of Pleasure Scale (TEPS) | 77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77 | A 17-item scale with anticipatory and consummatory components of the experience of pleasure. The scale is used as a proxy to assess a hypodopaminergic state. Worse Outcome: A lower score indicates low experience of pleasure (=proxy for hypodopaminergic state). Better outcome:A high score indicates high experience of pleasure. |
| Secondary | The Continous Performance Test + Activity Test | 77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7. | A neuropsychiatric tool addressing inattention, impulsivity and activity |
| Secondary | Plasma Concentration of Varenicline (ng/ml) | 14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of varenicline and above described outcome measures | Mean concentration of values obtained at visit 4 and visit 6 |
| Secondary | Plasma Concentration of Bupropion (ng/ml) | 14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of bupropion and above described outcome measures | Mean concentration of values obtained at visit 4 and visit 6 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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