Validation of a Test System for Development of Medications for Alcoholism
NCT02652585, Phase 3, Completed, Technische Universität Dresden
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Validation of a Test System for Development of Medications for Alcoholism | ClinicalTrials.gov |
| NCT number | NCT02652585 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 46 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Technische Universität Dresden | ClinicalTrials.gov |
| Conditions | Alcoholism | ClinicalTrials.gov |
| Interventions | Naltrexone, Placebo | ClinicalTrials.gov |
| First posted | 2016-01-12 | ClinicalTrials.gov |
| Last updated | 2017-09-27 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Difference CAT Trials alcohol | one year | Difference of cumulative number of work sets for alcohol in the "constant attention task" between first measurement (without medication) and second measurement (with medication) | ClinicalTrials.gov |
| Secondary | Difference CAT Trials sodium chloride solution | one year | Difference of cumulative number of work sets for sodium chloride solution in the "constant attention task" between first measurement (without medication) and second measurement (with medication) | ClinicalTrials.gov |
| Secondary | break Point alcohol | one year | Difference of the "break point" in the "progressive work" schedule for the work for alcohol between first measurement (without medication) and second measurement (with medication). The "break point" is the number of the last alcohol request before subjects stop to work for more alcohol. | ClinicalTrials.gov |
| Secondary | max. BAC | one year | Maximal achieved blood alcohol concentration (BAC) in alcohol self-administration between first measurement (without medication) and second measurement (with medication) | ClinicalTrials.gov |
| Secondary | Drinking habits | one year | Drinking habits measured with Timeline Follow-back Interview over 45 days before study start (measured at screening) and over the entire study duration (between screening and the last day of medicinal product intake, ascertained at visit 5): drinking days, amount of alcohol per drinking day and number of days with alcohol consumption over 60 g (men) or 48 g (women) | ClinicalTrials.gov |
| Secondary | CDT - level | one year | CDT - level: (carbohydrate-deficient transferrin), measured at visit 1 and visit 5 | ClinicalTrials.gov |
| Secondary | alcohol craving | one year | Alcohol craving in daily routine (OCD - scale) measured at visit 1 and visit 4 | ClinicalTrials.gov |
| Secondary | subjective alcohol effects | one year | Difference in subjective alcohol effects between first measurement (without medication) and second measurement (with medication), measured with visual analogue scales ("Quizzer") before, during and after the alcohol infusion | ClinicalTrials.gov |
| Secondary | motor impulse control | one year | Capacity for motor impulse control during infusion of physiologic saline solution or alcohol as NIMPs (single-blinded), measured with the counting stroop task (in Verum and placebo group) at visit 3 and 4 | ClinicalTrials.gov |
| Secondary | cerebral blood flow (CBF) | one year | Regional cerebral perfusion in ml/100 g tissue per Minute during infusion of sodium chloride solution or alcohol as NIMPs (single-blinded), measured with arterial spin labeling (ASL) under verum or placebo condition at visit 3 and 4 | ClinicalTrials.gov |
| Secondary | Cerebral resting state activity | one year | Cerebral resting state activity during infusion of sodium chloride solution or alcohol as NIMPs (single-blinded), measured with BOLD fMRI (in Verum and placebo group) at visit 3 and 4 | ClinicalTrials.gov |
| Secondary | adverse events | one year | Medical survey concerning occurring adverse events at visit 1 to 5 | ClinicalTrials.gov |
| Secondary | ALAT | one year | ALAT (alanine aminotransferase) in µmol/ s\*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5) | ClinicalTrials.gov |
| Secondary | ASAT | one year | ASAT (aspartate aminotransferase) in µmol/ s\*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5) | ClinicalTrials.gov |
| Secondary | Gamma-GT | one year | Gamma-GT in µmol/ s\*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5) | ClinicalTrials.gov |
| Secondary | standard blood cell count | one year | standard blood cell count before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5) | ClinicalTrials.gov |
| Secondary | creatinine | one year | creatinine in µmol/l before inclusion (screening visit) | ClinicalTrials.gov |
| Secondary | lipase | one year | lipase in µmol/ s\*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5) | ClinicalTrials.gov |
| Secondary | CRP | one year | CRP (C-reactive protein) in mg / l before inclusion (screening visit) and after finishing all study relating interventions (visit 5) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)