Alcohol Use DisorderNCT03816527
Selective Attention in Alcohol Use Disorder
An observational study of Alcohol Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
This study examines the selective attention to emotional- and alcohol- associated cues in alcohol- dependant and healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim
About this study
Official title: Selective Attention to Emotional and Alcohol-associated Cues in Patients With Alcohol Use Disorder and Healthy Participants
This study examines the selective attention to emotional- and alcohol- associated cues in alcohol- dependant and healthy participants.
Read the detailed description
The planned study will investigate the selective attention to emotional and alcohol-related stimuli in alcohol-dependent patients and healthy volunteers.
background Attitudinal shifts in the implicit cognitive processing of alcohol-associated stimuli play a major role in the maintenance of addictive disorders, in the development of alcohol cravings, and ultimately in relapse. There are several experimental methods to study the selective attention to image stimuli. For preliminary studies as well as for the planned study, we opted for the so-called Dotprobe task , in which image pairs (alcohol versus neutral stimulus) are presented. The selective attention can be measured by means of reaction time differences. In addition to alcohol-related stimuli, photos of fearful and happy faces that act as emotional stimuli are also used.
In a preliminary study, the investigators were able to show that not only alcoholics, but also healthy light social drinkers, showed an initial orientation towards alcohol stimuli. The presence of such a shift in attention to alcoholic stimuli, even in healthy individuals, could be a consequence of the processing of alcoholic stimuli as emotional stimuli of increased salience compared to affectively neutral stimuli. There are still no studies that collectively examine selective attention to both emotional and alcohol-associated stimuli. While some studies have shown selective attention to fear stimuli compared to neutral stimuli only in populations with clinically relevant increased anxiety, there are also studies who were able to show that there is selective attention to evolutionarily relevant anxiety even in healthy individuals. In these non-clinical populations, this selective attention appears to be particularly prevalent in subjects with increased anxiety.
Studies using affective positive stimuli such as happy faces showed selective attention to these positive valent stimuli in healthy people compared to neutral stimuli, which was also associated with the current mood . Thus, the selective attention to cheerful faces, for example, in a positive mood was also increased. Emotional processing is relevant in the development and maintenance of addictive diseases as well as in so-called "prolonged withdrawal". Thus, during abstinence among alcoholics, increased anxiety, irritability and dysphoria, the so-called "negative emotional state of withdrawal", appear. In a functional Magnetic Resonance Imaging (fMRI) study, it was shown that when anxious faces were seen, acute alcohol abuse had anxiolytic effects. In a separate study with disgusting images on cigarette packs as an aversive fear stimuli, we found that smokers showed a shift in attention to these disgusting images was associated with relief craving and was also associated with increased anxiety, especially in heavy smokers.
Objective:
The study will compare the selective attention to emotional and alcohol-related stimuli between alcoholics and healthy people. Furthermore, their association with positive and negative mood as well as anxiety should be considered. The aim is to investigate whether alcoholic stimuli are processed the same way in healthy people, such as appetitive, emotional stimuli and whether patients' alcohol stimuli are processed like aversive, emotional stimuli.
This question is interesting both methodically and clinically. On the one hand, it would be methodologically important to interpret whether healthy alcohol-associated stimuli are appetitive or similar to affectively positive stimuli for the interpretation of studies on selective attention to alcohol stimuli and alcohol-stimulant reactivity. Clinically significant would be the identification of patients with increased selective attention to alcohol and anxiety stimuli, for whom the risk of relapse could be increased by confronting these stimuli. From these findings, therapeutic options could be derived, such as the application of exposure therapies.
Hypotheses:
- Alcohol-dependent patients as well as healthy volunteers have a selective shift of attention to alcohol-associated versus neutral stimuli.
- The selective attention to happy faces is associated with positive mood.
- The selective attention to anxious faces is associated with the degree of anxiety.
- The selective attention to anxious faces is increased in alcoholics compared to healthy controls.
- The selective attention to happy faces is lowered in alcoholics in comparison to healthy controls.
- Selective attention to alcohol-associated stimuli in healthy controls is associated with positive mood.
- Selective attention to alcohol-related stimuli is associated with negative mood in alcohol-dependent patients.
Target population:
The study will examine 40 alcohol-dependent patients and 40 healthy volunteers.
- Conditions
- Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AUD patients | Individuals with alcohol use disorder | |
| Healthy controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: at examination 1 day (single examination, no follow-up)
Secondary outcomes (6)
severity of nicotine dependence
Fagerstrøm Test of Nicotine Dependence (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991)
Measured: at examination 1 day (single examination, no follow-up)
nicotine consumption
amount of nicotine consumed during the last 3 months (like (Scheurich et al., 2005) but for nicotine instead of alcohol)
Measured: at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months
alcohol consumption
amount of alcohol consumed during the last 3 months (Scheurich et al., 2005)
Measured: at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months
severity of alcohol use disorder
Alcohol Dependence Scale, ADS (Skinner \& Horn, 1984), score ranges between 0 and 47, higher score means higher severity of alcohol use disorder
Measured: at examination 1 day (single examination, no follow-up),
habitual alcohol consumption
automated and habitual alcohol consumption during the last 7 days, measured with Craving Automated Scale for Alcohol" (CAS-A) (Vollstädt-Klein et al., 2015). 5 subscales (factors): Factor 1 ("only aware in hindsight") ranges from 0 to 35, factor 2 ("no deliberate decision") from 0 to 35, factor 3 ("contrary to intention") from 0 to 40, factor 4 ("no perception") from 0 to 20, and factor 5 ("no control") from 0 to 10. , higher score means more habitual alcohol consumption
Measured: at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days
alcohol craving
measured with Obsessive Compulsive Drinking Scale (OCDS, (Mann \& Ackermann, 2000)), score ranges between 0 and 40, higher score means higher craving (obsessive-compulsive alcohol use)
Measured: at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: study not funded / no manpower
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Principal investigator, ZI Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816527
- Sponsor's protocol ID
- Emo-Dotprobe
- Status last verified
- Apr 2025
- First submitted
- 7 Jan 2019
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Attention to Emotional and Alcohol-associated Cues in Patients With Alcohol Use Disorder and Healthy Participants
- ClinicalTrials.gov ID
- NCT03816527
- Acronym / sponsor ID
- Emo-Dotprobe
- Conditions
- Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study not funded / no manpower
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the selective attention to emotional- and alcohol- associated cues in alcohol- dependant and healthy participants.
Detailed description
The planned study will investigate the selective attention to emotional and alcohol-related stimuli in alcohol-dependent patients and healthy volunteers.
background Attitudinal shifts in the implicit cognitive processing of alcohol-associated stimuli play a major role in the maintenance of addictive disorders, in the development of alcohol cravings, and ultimately in relapse. There are several experimental methods to study the selective attention to image stimuli. For preliminary studies as well as for the planned study, we opted for the so-called Dotprobe task , in which image pairs (alcohol versus neutral stimulus) are presented. The selective attention can be measured by means of reaction time differences. In addition to alcohol-related stimuli, photos of fearful and happy faces that act as emotional stimuli are also used.
In a preliminary study, the investigators were able to show that not only alcoholics, but also healthy light social drinkers, showed an initial orientation towards alcohol stimuli. The presence of such a shift in attention to alcoholic stimuli, even in healthy individuals, could be a consequence of the processing of alcoholic stimuli as emotional stimuli of increased salience compared to affectively neutral stimuli. There are still no studies that collectively examine selective attention to both emotional and alcohol-associated stimuli. While some studies have shown selective attention to fear stimuli compared to neutral stimuli only in populations with clinically relevant increased anxiety, there are also studies who were able to show that there is selective attention to evolutionarily relevant anxiety even in healthy individuals. In these non-clinical populations, this selective attention appears to be particularly prevalent in subjects with increased anxiety.
Studies using affective positive stimuli such as happy faces showed selective attention to these positive valent stimuli in healthy people compared to neutral stimuli, which was also associated with the current mood . Thus, the selective attention to cheerful faces, for example, in a positive mood was also increased. Emotional processing is relevant in the development and maintenance of addictive diseases as well as in so-called "prolonged withdrawal". Thus, during abstinence among alcoholics, increased anxiety, irritability and dysphoria, the so-called "negative emotional state of withdrawal", appear. In a functional Magnetic Resonance Imaging (fMRI) study, it was shown that when anxious faces were seen, acute alcohol abuse had anxiolytic effects. In a separate study with disgusting images on cigarette packs as an aversive fear stimuli, we found that smokers showed a shift in attention to these disgusting images was associated with relief craving and was also associated with increased anxiety, especially in heavy smokers.
Objective:
The study will compare the selective attention to emotional and alcohol-related stimuli between alcoholics and healthy people. Furthermore, their association with positive and negative mood as well as anxiety should be considered. The aim is to investigate whether alcoholic stimuli are processed the same way in healthy people, such as appetitive, emotional stimuli and whether patients' alcohol stimuli are processed like aversive, emotional stimuli.
This question is interesting both methodically and clinically. On the one hand, it would be methodologically important to interpret whether healthy alcohol-associated stimuli are appetitive or similar to affectively positive stimuli for the interpretation of studies on selective attention to alcohol stimuli and alcohol-stimulant reactivity. Clinically significant would be the identification of patients with increased selective attention to alcohol and anxiety stimuli, for whom the risk of relapse could be increased by confronting these stimuli. From these findings, therapeutic options could be derived, such as the application of exposure therapies.
Hypotheses:
- Alcohol-dependent patients as well as healthy volunteers have a selective shift of attention to alcohol-associated versus neutral stimuli.
- The selective attention to happy faces is associated with positive mood.
- The selective attention to anxious faces is associated with the degree of anxiety.
- The selective attention to anxious faces is increased in alcoholics compared to healthy controls.
- The selective attention to happy faces is lowered in alcoholics in comparison to healthy controls.
- Selective attention to alcohol-associated stimuli in healthy controls is associated with positive mood.
- Selective attention to alcohol-related stimuli is associated with negative mood in alcohol-dependent patients.
Target population:
The study will examine 40 alcohol-dependent patients and 40 healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUD patients | – | –Individuals with alcohol use disorder |
| Healthy controls | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
attentional bias to alcohol cues
Time frame: at examination 1 day (single examination, no follow-up)
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]
attentional bias to emotional cues
Time frame: at examination 1 day (single examination, no follow-up)
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]
6 secondary outcomes
severity of nicotine dependence
Time frame: at examination 1 day (single examination, no follow-up)
nicotine consumption
Time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months
alcohol consumption
Time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months
severity of alcohol use disorder
Time frame: at examination 1 day (single examination, no follow-up),
habitual alcohol consumption
Time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days
alcohol craving
Time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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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.
Sabine Vollstädt-Klein principal investigator
ZI Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 5 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: withdrawn, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
attentional bias to alcohol cues (time frame: at examination 1 day (single examination, no follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.