Web-based Alcohol-specific Inhibition Training in Adolescents and Young Adults With Alcohol Use Disorder

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder (AUD)

• Registration Number: NCT07071779
• Lead Sponsor: University of Bern

Brief Summary

Alcohol misuse is one of the most common risk factors for health problems and premature death among adolescents and young adults worldwide. Although there are effective treatments for alcohol use disorder (AUD), there is still a need to further improve their effectiveness and make them easier to access. Early research suggests that alcohol-specific inhibition training, when used in addition to specialized treatment, can improve treatment outcomes. This training aims to strengthen inhibition specifically in situations related to alcohol. The goal of this project is to offer this training for the first time in the form of a smartphone app, which is expected to increase the availability of the training. The main aim of the study is to evaluate whether this new app-based cognitive training is feasible as an add-on to the treatment of AUD in adolescents and young adults. In addition, the study will gather initial insights into whether the training affects drinking behavior and related brain processes. The project will be conducted as a double-blind, clinical pilot study. A total of 210 adolescents and young adults between 14 and 27 years old will be recruited from five specialized treatment centers. After the first study visit, participants will be randomly assigned to one of two groups: (1) an intervention group receiving the alcohol-specific inhibition training or (2) a control group receiving a similar alcohol-nonspecific inhibition training. During their participation, all participants will complete six short training sessions with the app. About one month later, they will complete six additional booster training sessions. This research may help develop effective, easily accessible tools to support young people with alcohol use disorder.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Age 14 - 27 years
• Alcohol use disorder identification test (AUDIT) ≥ 8
• Alcohol use disorder scale (AUD-S) ≥ 2
• Currently undergoing outpatient treatment or online counselling in one of 5 specialized treatment settings
• Sufficient German language skills
• Informed Consent as documented by signature
• Owner of a smartphone with internet access

Exclusion Criteria

• Other severe substance use (except nicotine and cannabis) determined by the cut-off value ≥ 25 in the drug use disorder identification test (DUDIT)
• Current medical conditions excluding participation
• Inability to read and understand the participant's information
• Enrolment of the investigator, his/her family members, employees, and other dependent persons

Additional exclusion criteria for Electroencephalography (EEG)-substudy:

• Current medication affecting EEG (e.g., benzodiazepines)
• Other severe substance use determined by the cut-off value ≥ 25 in the DUDIT (except nicotine)
• History of epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants recruited	From enrollment to the last assessment, approx. 16 weeks	Number of participants recruited during the recruitment period in all participating clinical centers is one indicator of the feasibility of implementing alcohol-specific inhibition training in a smartphone app.
Number of participants successfully completing the program	At the last assessment, approx. 16 weeks from enrollment	Number of participants successfully completing the program is one indicator of the feasibility of implementing alcohol-specific inhibition training in a smartphone app.
Proportion of participants completing the follow-up visits	At the last assessment, approx. 16 weeks from enrolment	Proportion of participants completing the follow-up visits is another indicator of feasibility.
Number of participants adhering to the treatment	From enrollment to last last training session, approx. 10 weeks	Number of participants adhering to the treatment, i.e. participating in all planned twelve training sessions, is another indicator of feasibility of implementing alcohol-specific inhibition training in a smartphone app.
Number of adverse events	From enrollment to the last assessment, approx. 16 weeks	Number of adverse events is another indicator of feasibility of implementing alcohol-specific inhibition training in a smartphone app.

Secondary Outcome Measures

Name	Time	Method
Percentage of days abstinent	At the last assessment, approx. 16 weeks from enrolment	Percentage of days abstinent is the main secondary outcome indicating preliminary effects on drinking behavior. It is measured by the Timeline Follow-Back method at 3-month follow-up.
Number of heavy drinking days	At the last assessment, approx. 16 weeks from enrolment	Number of heavy drinking days is another secondary outcome indicating preliminary effects on drinking behavior. It is measured by the Timeline Follow-Back method at 3-month follow-up.
P3-component of event-related potentials	4-6 weeks.	The electroencephalography (EEG) substudy will investigate whether iAlc-IT modifies neurophysiological alterations in alcohol-specific inhibition, the main secondary outcome here is the P3-component of event-related potentials measured with EEG.
N2-component of event-related potentials	4-6 weeks.	The electroencephalography (EEG) substudy will investigate whether iAlc-IT modifies neurophysiological alterations in alcohol-specific inhibition, another secondary outcome here is the N2-component of event-related potentials measured with EEG.

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland