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Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders (INTRA)

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ClinicalTrials.gov Identifier: NCT02968537
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Clinic Südhang
Forel Clinic
Psychiatric Center Muensingen
Information provided by (Responsible Party):
University of Bern

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Alc-IT (50/50) (morning) Behavioral: Alc-IT (75/25) (morning) Behavioral: Control-training (morning) Behavioral: Alc-IT (50/50) (afternoon) Behavioral: Alc-IT (75/25) (afternoon) Behavioral: Control-training (afternoon) Not Applicable

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)).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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.
Behavioral: 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.

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.
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.

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.
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.

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.
Behavioral: 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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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)

  5. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Time to first drink [ Time Frame: 3-, 6- and 12-months follow-up ]
  4. Percent heavy drinking days [ Time Frame: 3-, 6- and 12-months follow-up ]
  5. 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



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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968537


Contacts
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Contact: Maria Stein, PhD 0041 31 930 9752 stein@puk.unibe.ch

Locations
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Switzerland
Forel Klinik Completed
Ellikon, Switzerland
Klinik Südhang Recruiting
Kirchlindach, Switzerland
Contact: Leila Soravia         
Psychiatric Center Muensingen Recruiting
Münsingen, Switzerland
Contact: Hallie Batschelet         
Sponsors and Collaborators
University of Bern
Clinic Südhang
Forel Clinic
Psychiatric Center Muensingen
Investigators
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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

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02968537     History of Changes
Other Study ID Numbers: INTRA-2016-00988
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Bern:
Alcohol use disorders
inhibition
EEG
cortisol
Training
clinical outcome measures

Additional relevant MeSH terms:
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Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs