Alcohol DependenceNCT04054336
The Approach and Avoidance Task (AAT) in Alcoholic Inpatients
A study testing Inhibit AAT and classical AAT in people with Alcohol Dependence, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The approach and avoidance task (AAT) has evolved as a promising treatment add-on in the realm of psychology. Certain psychiatric diseases, such as behavioural addictions, social anxiety disorder, and arachnophobia, are characterized by a dysfunctional tendency to either approach or avoid disease-specific objects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Inhibit AAT and classical AAT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2017to 31 Aug 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of alcohol dependence (SKID-I)
- Abstinence from alcohol (at least 72 hours) and absence of major withdrawal symptoms
- Being in between 18-76 years of age
- Being able to understand rationales of the study and signing written informed consent
- Currently being inpatient seeking help overcoming alcohol dependence
- Medication allowed: Antiepileptic's (such as Carbamezepin), antidepressants, substances to treat other non-psychiatric diseases
Who cannot join
- Impaired ability to cooperate
- Presence of another substance dependency than alcohol and nicotine within the last year
- Presence of another axis-I disorder that interferes with the ability to cooperate within the study programme
- Current episode of a major depression
- Presence of axis-II disorders
- Presence of schizoaffective disorders
Show all 15Show fewer
- Alcohol consumption in between withdrawal and start of the study
- Somatic or neurological disease that precludes the proper execution of the study
- Long-term intake of neuroleptics or hypnotics
- Current intake of benzodiazepines or Clomethiazol (in the period of five half-value times prior to the start of the study)
- Participation in other studies or other treatments than treatment as usual
- Planned long-term therapy after 3-week withdrawal programme
- Being homeless
- Prior electroconvulsive therapy
- Language barriers that preclude proper understanding of study contents
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Hamburg-Eppendorf
Hamburg, 20246
Dimitrij Kugler, M.Sc., 0049 40 7410 24113, d.kugler@uke.de
About this study
Official title: Mechanisms Underlying the Approach and Avoidance Task (AAT) in Alcoholic Inpatients
The approach and avoidance task (AAT) has evolved as a promising treatment add-on in the realm of psychology. Certain psychiatric diseases, such as behavioural addictions, social anxiety disorder, and arachnophobia, are characterized by a dysfunctional tendency to either approach or avoid disease-specific objects. This tendency can be measured by means of the approach and avoidance task. In this so-called diagnostic AAT participants are instructed to react upon the format or the frame colour of a picture. For instance, pictures have to be pushed away if they are presented in landscape format and pulled towards oneself if they are presented in portrait format (or vice versa). Hence, the format (or the frame colour) becomes the task-relevant dimension, whereas the content of the picture becomes the task-irrelevant dimension. However, what generally becomes obvious in the psychiatric diseases mentioned above is that the task-irrelevant dimension (picture content) exerts an influence on reaction times. For instance, alcoholic patients are generally faster to respond if alcoholic pictures are presented in a format requiring them to pull towards themselves and slower to respond if alcoholic pictures are shown in the format requiring them to push away a joystick. This behavioural tendency has been termed an approach bias for alcohol.
In order to counteract these dysfunctional approach or avoidance tendencies, an AAT-training has been developed. In this training participants/patients learn to either avoid or approach disease-specific objects. Alcohol-dependent patients, for instance, learn to avoid alcohol-related pictures by pushing or swiping the image away. It has been shown that these trainings can enhance treatment outcome (e.g. lower relapse rates) among alcohol-addicted patients (Wiers, Eberl, Rinck, Becker, \& Lindenmeyer, 2011). The aim of the current study is to test whether the avoidance gesture is as important as suggested by the AAT's name or whether inhibiting the urge to approach alcoholic content might be enough to bring about the effect.
Read the detailed description
The approach and avoidance task (AAT) has turned out as both a promising diagnostic tool as well as treatment add-on in psychological science. The AAT constitutes one form of cognitive bias modification (CBM), which has been shown to be particularly effective in the field of behavioral addictions, such as alcohol addiction (Eberl et al., 2013; Wiers et al., 2011). The general logic underlying the AAT is to carry out actions that are either compatible or incompatible with an individual's action tendencies. For instance, alcohol addicted patients tend to approach alcohol related stimuli faster than control pictures (i.e. soft drink stimuli), when they are instructed to react upon the format of a picture and not to its' content. This tendency of comparatively faster approaching and slower avoiding alcohol-related stimuli than soft drink content has been termed an approach bias for alcohol. The AAT as a therapeutic tool tries to counteract or at least to attenuate approach or avoidance biases by instructing patients to carry out approach and avoidance gestures that are in conflict with an individual's acquired action tendencies.
Whereas the general effectiveness of the AAT as a clinical intervention has been demonstrated several times, little is known about possible mechanisms that might subserve these effects. Therefore, the current study is dedicated to shed some light on one such potential mechanism, i.e. the role of the avoidance gesture within the alcohol-AAT.
As already suggested by the name of the AAT, the avoidance gesture seems to be a key ingredient in bringing about therapeutic effects. However, recent empirical evidence has brought about some interesting findings, giving rise to an alternative explanation.
A study by Kühn et al. (2017), contrary to common-held beliefs, indicated that inhibition capacity can be trained. Inhibition, in turn, consistently has been linked to psychopathology and all kinds of behavioural addictions (Smith, Mattick, Jamadar, \& Iredale, 2014). The game by Kühn et al. (2017) used to train inhibition resembled the AAT in several ways, e.g. certain stimuli appearing on a treadmill had to be collected by swiping towards oneself and others had to be ignored and the objects slowly disappeared. The latter element contrasts with the AAT, since the ignored objects don't have to be pushed away. However, it resembles the AAT in the sense that in both cases stimuli slowly fade out of the screen and eventually disappear. These parallel let to the assumption that a new form of the alcohol AAT training might be equally effective in lowering relapse rates among alcoholic patients. More precisely, within the newly conceptualized AAT training patients are instructed to inhibit the urge to respond in response to alcohol-related content and to observe the stimuli fading out of the screen. In contrast, to the classical AAT training this zooming out of alcoholic stimuli is not conditional on an avoidance gesture, i.e. swiping/pushing away the stimulus.
It is hypothesized that compared to a control group, in which alcohol and soft drink stimuli have to be swiped to the left and right, both the classical AAT-and the inhibition group will show lower relapse rates and approach biases after the intervention, i.e. a training period of three weeks. No intergroup differences in terms of relapse rates and alcohol-related approach bias are expected for the classical AAT group and the inhibition group.
- Conditions
- Alcohol Dependence
- Being tested
- Inhibit AAT, classical AAT, Control Group
- Keywords
- Approach and Avoidance Task, Inhibition
- Medical subject headings
- Alcoholism, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibit AATBehavioural
Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
classical AATBehavioural
Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
Control GroupBehavioural
Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
| Study group | Role | What they receive |
|---|---|---|
| Inhibition group | Experimental | The inhibition group gets the instructions to respond to pictures containing soft drinks by swiping/pulling them towards themselves, whereas pictures with alcoholic content shall be ignored. Up on pulling the pictures successively enlarge, whereas they shrink when ignored and slowly fade out. Receives: Behavioral: Inhibit AAT |
| Classical AAT group | Experimental | The classical AAT group is provided with a tablet on which an explicit AAT training is installed. Thus, just as participants in the inhibition group, participants are instructed to react upon soft drinks by swiping/pulling towards themselves the picture. Pictures containing alcoholic content shall be pushed away. Up on pulling pictures enlarge and up on pushing they shrink until they fade out. Receives: Behavioral: classical AAT |
| Control group | Sham comparator | This type of active control group receives the instructions to swipe alcohol pictures to the left and soft drink pictures to the right (or vice versa depending on the sequential counterbalancing procedure). Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Is measured by means of the timeline followback (TLFB). In the TLFB a thirty day period prior to hospitalization is inquired to get an impression of the alcohol consumption before detoxification. Both after the intervention period and at the follow-up measure 9 weeks after the end of the intervention period the TLFB is administered to the participants again. Thus, in total a period of 3 months after the enrollment in the study is captured by means of the TLFB and can be compared between groups and with baseline consumption of each individual.
Measured: 3 months
Relapse rate
At each point of measurement it is inquired whether participants had a relapse. In order to enrich these self-reports, breathalysers are used to screen for possible alcohol intake prior to the appointment.
Measured: 3 months
Secondary outcomes (12)
Diagnostic AAT
In order to look whether participants' approach bias for alcohol changes as a consequence of the intervention, the diagnostic AAT is administered to all participants at every point of measurement.
Measured: 3 months
Obsessive Compulsive Drinking Scale
A measure of aclohol addiction severity and craving.
Measured: 3 months
Alcohol Urge Questionnaire
Assesses the urge to consume alcohol.
Measured: 3 months
The State Trait Anxiety Inventory (STAI)
Is a commonly used measure of state and trait anxiety. Trait anxiety is assessed at the baseline measure, whereas potential changes in state anxiety are monitored across all three points of measurement of the study.
Measured: 3 months
Positive and Negative Affect Schedule
Is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect.
Measured: 3 months
Self-Control Scale
The self-control scale aims to assess people's ability to control their impulses, alter their emotions and thoughts, and to interrupt undesired behavioural tendencies and refrain from acting on them.
Measured: 3 months
Becks's Depression Inventory
Assesses the degree of depressive symptoms.
Measured: 3 months
Fagerström Test of Nicotine Dependence (FTND)
Fagerstrom test for nicotine addiction determines the degree of nicotine dependence based on smoking habits and frequency.
Measured: 3 months
Barrett Impulsiveness Scale
A questionnaire designed to assess the personality/behavioral construct of impulsiveness.
Measured: 3 months
Behavioral inhibition/avoidance scales
The BIS/BAS Scale is a 24-item self-report questionnaire designed to measure two motivational systems: the behavioral inhibition system (BIS), which corresponds to motivation to avoid aversive outcomes, and the behavioral activation system (BAS), which corresponds to motivation to approach goal-oriented outcomes.
Measured: 3 months
Rating of pictures used in the study
Liking of all alcoholic and non alcoholic stimuli used in the study will be rated on a visual analogue scale, ranging from 0 to 100.
Measured: 3 months
Expectancy Inventory of the intervention
Assesses an individual's expectancies and belief in positive outcomes associated with the training and alcohol treatment in general.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start2 Feb 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Alcohol patients are randomly assigned to one of three conditions and are tested on three consecutive points in time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Kühn, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054336
- Sponsor's protocol ID
- AAT001
- Status last verified
- Aug 2019
- First submitted
- 11 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuhn S, Lorenz RC, Weichenberger M, Becker M, Haesner M, O'Sullivan J, Steinert A, Steinhagen-Thiessen E, Brandhorst S, Bremer T, Gallinat J. Taking control! Structural and behavioural plasticity in response to game-based inhibition training in older adults. Neuroimage. 2017 Aug 1;156:199-206. doi: 10.1016/j.neuroimage.2017.05.026. Epub 2017 May 17.
PubMed 28527788Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.
PubMed 23218805Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
PubMed 21389338Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24.
PubMed 25195081
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Approach and Avoidance Task (AAT) in Alcoholic Inpatients
- ClinicalTrials.gov ID
- NCT04054336
- Acronym / sponsor ID
- AAT001
- Conditions
- Alcohol Dependence
- Keywords
- Approach and Avoidance Task, Inhibition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 13 Aug 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.
The approach and avoidance task (AAT) has evolved as a promising treatment add-on in the realm of psychology. Certain psychiatric diseases, such as behavioural addictions, social anxiety disorder, and arachnophobia, are characterized by a dysfunctional tendency to either approach or avoid disease-specific objects. This tendency can be measured by means of the approach and avoidance task. In this so-called diagnostic AAT participants are instructed to react upon the format or the frame colour of a picture. For instance, pictures have to be pushed away if they are presented in landscape format and pulled towards oneself if they are presented in portrait format (or vice versa). Hence, the format (or the frame colour) becomes the task-relevant dimension, whereas the content of the picture becomes the task-irrelevant dimension. However, what generally becomes obvious in the psychiatric diseases mentioned above is that the task-irrelevant dimension (picture content) exerts an influence on reaction times. For instance, alcoholic patients are generally faster to respond if alcoholic pictures are presented in a format requiring them to pull towards themselves and slower to respond if alcoholic pictures are shown in the format requiring them to push away a joystick. This behavioural tendency has been termed an approach bias for alcohol.
In order to counteract these dysfunctional approach or avoidance tendencies, an AAT-training has been developed. In this training participants/patients learn to either avoid or approach disease-specific objects. Alcohol-dependent patients, for instance, learn to avoid alcohol-related pictures by pushing or swiping the image away. It has been shown that these trainings can enhance treatment outcome (e.g. lower relapse rates) among alcohol-addicted patients (Wiers, Eberl, Rinck, Becker, \& Lindenmeyer, 2011). The aim of the current study is to test whether the avoidance gesture is as important as suggested by the AAT's name or whether inhibiting the urge to approach alcoholic content might be enough to bring about the effect.
Detailed description
The approach and avoidance task (AAT) has turned out as both a promising diagnostic tool as well as treatment add-on in psychological science. The AAT constitutes one form of cognitive bias modification (CBM), which has been shown to be particularly effective in the field of behavioral addictions, such as alcohol addiction (Eberl et al., 2013; Wiers et al., 2011). The general logic underlying the AAT is to carry out actions that are either compatible or incompatible with an individual's action tendencies. For instance, alcohol addicted patients tend to approach alcohol related stimuli faster than control pictures (i.e. soft drink stimuli), when they are instructed to react upon the format of a picture and not to its' content. This tendency of comparatively faster approaching and slower avoiding alcohol-related stimuli than soft drink content has been termed an approach bias for alcohol. The AAT as a therapeutic tool tries to counteract or at least to attenuate approach or avoidance biases by instructing patients to carry out approach and avoidance gestures that are in conflict with an individual's acquired action tendencies.
Whereas the general effectiveness of the AAT as a clinical intervention has been demonstrated several times, little is known about possible mechanisms that might subserve these effects. Therefore, the current study is dedicated to shed some light on one such potential mechanism, i.e. the role of the avoidance gesture within the alcohol-AAT.
As already suggested by the name of the AAT, the avoidance gesture seems to be a key ingredient in bringing about therapeutic effects. However, recent empirical evidence has brought about some interesting findings, giving rise to an alternative explanation.
A study by Kühn et al. (2017), contrary to common-held beliefs, indicated that inhibition capacity can be trained. Inhibition, in turn, consistently has been linked to psychopathology and all kinds of behavioural addictions (Smith, Mattick, Jamadar, \& Iredale, 2014). The game by Kühn et al. (2017) used to train inhibition resembled the AAT in several ways, e.g. certain stimuli appearing on a treadmill had to be collected by swiping towards oneself and others had to be ignored and the objects slowly disappeared. The latter element contrasts with the AAT, since the ignored objects don't have to be pushed away. However, it resembles the AAT in the sense that in both cases stimuli slowly fade out of the screen and eventually disappear. These parallel let to the assumption that a new form of the alcohol AAT training might be equally effective in lowering relapse rates among alcoholic patients. More precisely, within the newly conceptualized AAT training patients are instructed to inhibit the urge to respond in response to alcohol-related content and to observe the stimuli fading out of the screen. In contrast, to the classical AAT training this zooming out of alcoholic stimuli is not conditional on an avoidance gesture, i.e. swiping/pushing away the stimulus.
It is hypothesized that compared to a control group, in which alcohol and soft drink stimuli have to be swiped to the left and right, both the classical AAT-and the inhibition group will show lower relapse rates and approach biases after the intervention, i.e. a training period of three weeks. No intergroup differences in terms of relapse rates and alcohol-related approach bias are expected for the classical AAT group and the inhibition group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Alcohol patients are randomly assigned to one of three conditions and are tested on three consecutive points in time.
| Arm | Type | Receives |
|---|---|---|
| Inhibition group | Experimental | Behavioral: Inhibit AATThe inhibition group gets the instructions to respond to pictures containing soft drinks by swiping/pulling them towards themselves, whereas pictures with alcoholic content shall be ignored. Up on pulling the pictures successively enlarge, whereas they shrink when ignored and slowly fade out. |
| Classical AAT group | Experimental | Behavioral: classical AATThe classical AAT group is provided with a tablet on which an explicit AAT training is installed. Thus, just as participants in the inhibition group, participants are instructed to react upon soft drinks by swiping/pulling towards themselves the picture. Pictures containing alcoholic content shall be pushed away. Up on pulling pictures enlarge and up on pushing they shrink until they fade out. |
| Control group | Sham comparator | Behavioral: Control GroupThis type of active control group receives the instructions to swipe alcohol pictures to the left and soft drink pictures to the right (or vice versa depending on the sequential counterbalancing procedure). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of alcohol dependence (SKID-I)
- Abstinence from alcohol (at least 72 hours) and absence of major withdrawal symptoms
- Being in between 18-76 years of age
- Being able to understand rationales of the study and signing written informed consent
- Currently being inpatient seeking help overcoming alcohol dependence
Key exclusion criteria (15 listed)
- Impaired ability to cooperate
- Presence of another substance dependency than alcohol and nicotine within the last year
- Presence of another axis-I disorder that interferes with the ability to cooperate within the study programme
- Current episode of a major depression
- Presence of axis-II disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhibit AATParticipants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day. | Behavioural | Inhibition group |
| classical AATParticipants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day. | Behavioural | Classical AAT group |
| Control GroupParticipants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day. | Behavioural | Control group |
Primary outcome
Alcohol consumption
Time frame: 3 months
Is measured by means of the timeline followback (TLFB). In the TLFB a thirty day period prior to hospitalization is inquired to get an impression of the alcohol consumption before detoxification. Both after the intervention period and at the follow-up measure 9 weeks after the end of the intervention period the TLFB is administered to the participants again. Thus, in total a period of 3 months after the enrollment in the study is captured by means of the TLFB and can be compared between groups and with baseline consumption of each individual.
Relapse rate
Time frame: 3 months
At each point of measurement it is inquired whether participants had a relapse. In order to enrich these self-reports, breathalysers are used to screen for possible alcohol intake prior to the appointment.
12 secondary outcomes
Diagnostic AAT
Time frame: 3 months
Obsessive Compulsive Drinking Scale
Time frame: 3 months
Alcohol Urge Questionnaire
Time frame: 3 months
The State Trait Anxiety Inventory (STAI)
Time frame: 3 months
Positive and Negative Affect Schedule
Time frame: 3 months
Self-Control Scale
Time frame: 3 months
Becks's Depression Inventory
Time frame: 3 months
Fagerström Test of Nicotine Dependence (FTND)
Time frame: 3 months
Barrett Impulsiveness Scale
Time frame: 3 months
Behavioral inhibition/avoidance scales
Time frame: 3 months
Rating of pictures used in the study
Time frame: 3 months
Expectancy Inventory of the intervention
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Results publication: PubMed 28527788Kuhn S, Lorenz RC, Weichenberger M, Becker M, Haesner M, O'Sullivan J, Steinert A, Steinhagen-Thiessen E, Brandhorst S, Bremer T, Gallinat J. Taking control! Structural and behavioural plasticity in response to game-based inhibition training in older adults. Neuroimage. 2017 Aug 1;156:199-206. doi: 10.1016/j.neuroimage.2017.05.026. Epub 2017 May 17.
- Results publication: PubMed 23218805Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.
- Results publication: PubMed 21389338Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
- Results publication: PubMed 25195081Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24.
- Individual participant dataSharing planned: No
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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.
Simone Kühn, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhibit AAT and classical AAT in people with Alcohol Dependence, run by Universitätsklinikum Hamburg-Eppendorf 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 15 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrij Kugler, M.Sc. (0049 40 7410 24113, d.kugler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT04054336, which also lists 4 linked publications.
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 13 Aug 2019.