NCT03816527

Brief Summary

This study examines the selective attention to emotional- and alcohol- associated cues in alcohol- dependant and healthy participants.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

January 7, 2019

Last Update Submit

April 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • attentional bias to alcohol cues

    measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) \[reaction time differences is not a change over time; it is measured during one experimental session\]

    at examination 1 day (single examination, no follow-up)

  • attentional bias to emotional cues

    measured with reaction time differences (in milliseconds) using the dotprobe-task (like in Vollstädt-Klein et al. 2009, but with emotional pictures) \[reaction time differences is not a change over time; it is measured during one experimental session\]

    at examination 1 day (single examination, no follow-up)

Secondary Outcomes (6)

  • severity of nicotine dependence

    at examination 1 day (single examination, no follow-up)

  • nicotine consumption

    at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months

  • alcohol consumption

    at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months

  • severity of alcohol use disorder

    at examination 1 day (single examination, no follow-up),

  • habitual alcohol consumption

    at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days

  • +1 more secondary outcomes

Study Arms (2)

AUD patients

Individuals with alcohol use disorder

Healthy controls

Healthy controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

group 1: patients with alcohol use disorder, recruited in the Clinic of the Department of Addictive Behaviour and Addiction Medicine group 2: healthy controls, recruited from the local community

You may qualify if:

  • Women of childbearing age
  • Women an Men between 18 and 65 years
  • Adequate ability to reach an Agreement with the Investigator, to answer oral and written questions
  • Ability to consent after detailed reconnaissance
  • Written informed consent
  • Patients: Diagnosis of alcohol use disorder

You may not qualify if:

  • Participants wich are unable to consent
  • Severe internal, neurological ans psychiatric comorbidities
  • Abstinence phenomenon (CIWA-R \> 3)
  • Axis I psychiatric disorder (except nicotine dependence and specific phobias within the last 12 months as well as patients with alcohol use disorder)
  • Pharmacotherapy with psychoactive substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sabine Vollstädt-Klein

    ZI Mannheim

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 25, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations