Alcohol DependenceINTRANCT02968537
Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders
A study testing Alc-IT (50/50) (morning), Alc-IT (75/25) (morning) and Alc-IT (50/50) (afternoon) in people with Alcohol Dependence, run by University of Bern at 3 sites in Switzerland.
Trial summary
The study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Alc-IT (50/50) (morning), Alc-IT (75/25) (morning) and Alc-IT (50/50) (afternoon)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Dec 2016to Jul 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 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Abstinent patients with an alcohol use disorder in the 12-week inpatient program of the Clinic Südhang or the Forel Clinic,
- Abstained from alcohol for at least 4 weeks (in relation to timepoint when training will start),
- Informed Consent as documented by signature.
Who cannot join
- Other main psychiatric diagnosis than alcohol use disorder (comorbidity is allowed if the alcohol use disorder is to be considered the main diagnosis),
- other severe substance use disorder (except nicotine), even as secondary diagnosis
- Neurocognitive problems (e.g. Korsakoff syndrome),
- Current medical conditions excluding participation (e.g. acute infectious disease),
- Inability to read and understand the participant's information,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Forel Klinik
Ellikon
Klinik Südhang
Kirchlindach
Psychiatric Center Muensingen
Münsingen
About this study
Official title: Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial
The study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder.
Read the detailed description
Therapeutic interventions to treat alcohol use disorders (AUD) still need to be improved. A novel alcohol-specific inhibition-training seems to be a promising new intervention. In this study, recently abstinent patients with AUD attending an inpatient treatment program will be randomly assigned to one of two alcohol-specific inhibition-training groups (varying in Go/NoGo-ratio) or to a control condition. Besides the effects on drinking behavior, inhibition and implicit attitudes, the investigators expect the training to influence neurophysiological reactivity to alcohol related stimuli. A subgroup of patients will therefore additionally undergo EEG recording so that the neurophysiological effects of the training can be assessed and related to clinical outcome. Furthermore, since training effects rely on learning processes, the influence of endogenous cortisol level (a consolidation-enhancer which peaks in the morning) on training outcome will be examined by the variation of daytime of the training. All patients' inhibitory control and implicit associations towards alcohol will be measured before and after training. The training effects will be examined on proximal outcome variables (e.g. implicit associations, inhibitory control, abstinence related self-efficacy, craving) and on distal outcome variables at 3-, 6- and 12- months follow-up (e.g. percent abstinent days (primary outcome)).
- Conditions
- Alcohol Dependence
- Being tested
- Alc-IT (50/50) (morning), Alc-IT (75/25) (morning), Control-training (morning), Alc-IT (50/50) (afternoon), Alc-IT (75/25) (afternoon)
- Keywords
- Alcohol use disorders, inhibition, EEG, cortisol, Training, clinical outcome measures
- 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.
Alc-IT (50/50) (morning)Behavioural
This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening.
Alc-IT (75/25) (morning)Behavioural
This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening.
Control-training (morning)Behavioural
This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening.
Alc-IT (50/50) (afternoon)Behavioural
As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.
Alc-IT (75/25) (afternoon)Behavioural
As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.
Control-training (afternoon)Behavioural
As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| Alc-IT (50/50) (morning) | Experimental | Alc-IT (50/50) (morning): This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening. Receives: Behavioral: Alc-IT (50/50) (morning) |
| Alc-IT (75/25) (morning) | Experimental | This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening. Receives: Behavioral: Alc-IT (75/25) (morning) |
| Control-training (morning) | Placebo comparator | This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening. Receives: Behavioral: Control-training (morning) |
| Alc-IT (50/50) (afternoon) | Experimental | Alc-IT (50/50) (afternoon): As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. Receives: Behavioral: Alc-IT (50/50) (afternoon) |
| Alc-IT (75/25) (afternoon) | Experimental | As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. Receives: Behavioral: Alc-IT (75/25) (afternoon) |
| Control-training (afternoon) | Placebo comparator | As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. Receives: Behavioral: Control-training (afternoon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days of abstinence 3-months follow-up.
Percentage of abstinent days in 3-months follow-up. This will be measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.
Measured: 3-months follow-up
Inhibition Go/NoGo
Inhibitory control as assessed with a Go/NoGo task.
Measured: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Neurophysiology of inhibitory Control (Go/NoGo)
Neurophysiological correlates of inhibitory control as assessed with EEG-measurement during the Go-NOGo-task. ERPs in response to NoGo-Stimuli will be calculated and the N2/p3-complex will be analyzed
Measured: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Implicit associations (IAT)
Implicit associations as assessed with an alcohol-related implicit association task (IAT)
Measured: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Heavy drinking days in 3 months follow-up
in 3-months follow-up. This will be measured Heavy drinking days in 3 months follow-up, measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.
Measured: 3 months follow-up
Secondary outcomes (5)
Abstinence related self-efficacy
Self efficacy will be assessed with the alcohol abstinence self-efficacy scale (AASE).
Measured: Post-training (i.e. between 1 and 7 days after completion of the training session); discharge, 3-, 6- and 12-months follow-up
Craving
Craving will be measured with the German version of the Obsessive compulsive drinking scale (OCDS-G).
Measured: Post-training (i.e. between 1 and 7 days after completion of the last training session); discharge, 3-, 6- and 12-months follow-up
Time to first drink
Measured: 3-, 6- and 12-months follow-up
Percent heavy drinking days
Measured: 3-, 6- and 12-months follow-up
Inhibition (SST)
Inhibitory control will be assessed with a Stop-Signal task
Measured: Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Clinic Südhang, Forel Clinic, Psychiatric Center Muensingen
- Responsible party
- Sponsor
- Investigators
- Maria Stein, PhD, Principal investigator, University of Bern, University Hospital for PsychiatryLeila Soravia, PhD, Principal investigator, University of Bern, University Hospital for PsychiatryFranz Moggi, PD, Principal investigator, University of Bern, University Hospital for Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968537
- Sponsor's protocol ID
- INTRA-2016-00988
- Acronym
- INTRA
- Status last verified
- May 2022
- First submitted
- 10 Nov 2016
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Denier N, Zahnd K, Stein M, Moggi F, Kupper Z, Federspiel A, Wiest R, Grieder M, Soravia LM, Bracht T. Brain Connectivity of the Cingulate Cortex in Alcohol Use Disorder: Exploring Its Association With Mindfulness. Addict Biol. 2025 Oct;30(10):e70036. doi: 10.1111/adb.70036.
PubMed 41070735Tschuemperlin RM, Stein M, Batschelet HM, Moggi F, Soravia LM. Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder. Trials. 2019 Jul 5;20(1):402. doi: 10.1186/s13063-019-3505-2.
PubMed 31277683
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02968537
- Acronym / sponsor ID
- INTRA / INTRA-2016-00988
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol use disorders, inhibition, EEG, cortisol, Training, clinical outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Clinic Südhang, Forel Clinic, Psychiatric Center Muensingen
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 18 Nov 2016 (estimated)
- 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 study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder.
Detailed description
Therapeutic interventions to treat alcohol use disorders (AUD) still need to be improved. A novel alcohol-specific inhibition-training seems to be a promising new intervention. In this study, recently abstinent patients with AUD attending an inpatient treatment program will be randomly assigned to one of two alcohol-specific inhibition-training groups (varying in Go/NoGo-ratio) or to a control condition. Besides the effects on drinking behavior, inhibition and implicit attitudes, the investigators expect the training to influence neurophysiological reactivity to alcohol related stimuli. A subgroup of patients will therefore additionally undergo EEG recording so that the neurophysiological effects of the training can be assessed and related to clinical outcome. Furthermore, since training effects rely on learning processes, the influence of endogenous cortisol level (a consolidation-enhancer which peaks in the morning) on training outcome will be examined by the variation of daytime of the training. All patients' inhibitory control and implicit associations towards alcohol will be measured before and after training. The training effects will be examined on proximal outcome variables (e.g. implicit associations, inhibitory control, abstinence related self-efficacy, craving) and on distal outcome variables at 3-, 6- and 12- months follow-up (e.g. percent abstinent days (primary outcome)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Alc-IT (50/50) (morning) | Experimental | Behavioral: Alc-IT (50/50) (morning)Alc-IT (50/50) (morning): This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening. |
| Alc-IT (75/25) (morning) | Experimental | Behavioral: Alc-IT (75/25) (morning)This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening. |
| Control-training (morning) | Placebo comparator | Behavioral: Control-training (morning)This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening. |
| Alc-IT (50/50) (afternoon) | Experimental | Behavioral: Alc-IT (50/50) (afternoon)Alc-IT (50/50) (afternoon): As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. |
| Alc-IT (75/25) (afternoon) | Experimental | Behavioral: Alc-IT (75/25) (afternoon)As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. |
| Control-training (afternoon) | Placebo comparator | Behavioral: Control-training (afternoon)As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Abstinent patients with an alcohol use disorder in the 12-week inpatient program of the Clinic Südhang or the Forel Clinic,
- Abstained from alcohol for at least 4 weeks (in relation to timepoint when training will start),
- Informed Consent as documented by signature.
Key exclusion criteria (6 listed)
- Other main psychiatric diagnosis than alcohol use disorder (comorbidity is allowed if the alcohol use disorder is to be considered the main diagnosis),
- other severe substance use disorder (except nicotine), even as secondary diagnosis
- Neurocognitive problems (e.g. Korsakoff syndrome),
- Current medical conditions excluding participation (e.g. acute infectious disease),
- Inability to read and understand the participant's information,
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 |
|---|---|---|
| Alc-IT (50/50) (morning)This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening. | Behavioural | Alc-IT (50/50) (morning) |
| Alc-IT (75/25) (morning)This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening. | Behavioural | Alc-IT (75/25) (morning) |
| Control-training (morning)This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening. | Behavioural | Control-training (morning) |
| Alc-IT (50/50) (afternoon)As in the arm "Alc-IT (50/50) (morning)", this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. | Behavioural | Alc-IT (50/50) (afternoon) |
| Alc-IT (75/25) (afternoon)As in the arm "Alc-IT (75/25) (morning)", this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. | Behavioural | Alc-IT (75/25) (afternoon) |
| Control-training (afternoon)As in the arm "Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon. | Behavioural | Control-training (afternoon) |
Primary outcome
Percent days of abstinence 3-months follow-up.
Time frame: 3-months follow-up
Percentage of abstinent days in 3-months follow-up. This will be measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.
Inhibition Go/NoGo
Time frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Inhibitory control as assessed with a Go/NoGo task.
Neurophysiology of inhibitory Control (Go/NoGo)
Time frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Neurophysiological correlates of inhibitory control as assessed with EEG-measurement during the Go-NOGo-task. ERPs in response to NoGo-Stimuli will be calculated and the N2/p3-complex will be analyzed
Implicit associations (IAT)
Time frame: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Implicit associations as assessed with an alcohol-related implicit association task (IAT)
Heavy drinking days in 3 months follow-up
Time frame: 3 months follow-up
in 3-months follow-up. This will be measured Heavy drinking days in 3 months follow-up, measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.
5 secondary outcomes
Abstinence related self-efficacy
Time frame: Post-training (i.e. between 1 and 7 days after completion of the training session); discharge, 3-, 6- and 12-months follow-up
Craving
Time frame: Post-training (i.e. between 1 and 7 days after completion of the last training session); discharge, 3-, 6- and 12-months follow-up
Time to first drink
Time frame: 3-, 6- and 12-months follow-up
Percent heavy drinking days
Time frame: 3-, 6- and 12-months follow-up
Inhibition (SST)
Time frame: Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 41070735Denier N, Zahnd K, Stein M, Moggi F, Kupper Z, Federspiel A, Wiest R, Grieder M, Soravia LM, Bracht T. Brain Connectivity of the Cingulate Cortex in Alcohol Use Disorder: Exploring Its Association With Mindfulness. Addict Biol. 2025 Oct;30(10):e70036. doi: 10.1111/adb.70036.
- Derived from this study: PubMed 31277683Tschuemperlin RM, Stein M, Batschelet HM, Moggi F, Soravia LM. Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder. Trials. 2019 Jul 5;20(1):402. doi: 10.1186/s13063-019-3505-2.
- 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.
Maria Stein, PhD principal investigator
University of Bern, University Hospital for Psychiatry
Leila Soravia, PhD principal investigator
University of Bern, University Hospital for Psychiatry
Franz Moggi, PD principal investigator
University of Bern, University Hospital for Psychiatry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alc-IT (50/50) (morning), Alc-IT (75/25) (morning) and Alc-IT (50/50) (afternoon) in people with Alcohol Dependence, run by University of Bern at 3 sites in Switzerland.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent days of abstinence 3-months follow-up. (time frame: 3-months follow-up). The study lists 5 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 NCT02968537, which also lists 2 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 4 May 2022.