- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968537
Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders (INTRA)
May 3, 2022 updated by: University of Bern
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
242
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ellikon, Switzerland
- Forel Klinik
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Kirchlindach, Switzerland
- Klinik Südhang
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Münsingen, Switzerland
- Psychiatric Center Muensingen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 18 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
Placebo Comparator: 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.
|
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.
|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
Placebo Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-months follow-up
|
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.
|
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)
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
|
Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
|
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)
|
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
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.
|
3 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Self efficacy will be assessed with the alcohol abstinence self-efficacy scale (AASE).
|
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
|
Craving will be measured with the German version of the Obsessive compulsive drinking scale (OCDS-G).
|
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
|
3-, 6- and 12-months follow-up
|
|
Percent heavy drinking days
Time Frame: 3-, 6- and 12-months follow-up
|
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
|
Inhibitory control will be assessed with a Stop-Signal task
|
Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Stein, PhD, University of Bern, University Hospital for Psychiatry
- Principal Investigator: Leila Soravia, PhD, University of Bern, University Hospital for Psychiatry
- Principal Investigator: Franz Moggi, PD, University of Bern, University Hospital for Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
November 10, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 18, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INTRA-2016-00988
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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