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

NCT07071779 | Recruiting DMC

• 1 other identifier: BASEC2024-01150
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Substance 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 substance use disorder (SUD), there is still a need to further improve their effectiveness and make them easier to access. Early research suggests that substance-specific inhibition training, when used in addition to specialized treatment, can improve treatment outcomes. This training aims to strengthen inhibition specifically in situations with substance-related cues. 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 SUD in adolescents and young adults. In addition, the study will gather preliminary 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 35 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 substance use disorder.

Conditions

Substance Use Disorder (SUD); Alcohol Use Disorder (AUD); Cocaine Use Disorder (CUD)

Keywords

Alcohol use disorder; Alcohol-specific inhibition training; Cognitive bias modification; Feasibility pilot randomized controlled trial; Cocaine Use Disorder (CUD); Substance Use Disorder (SUD); Cocaine-specific inhibition training; Substance-specific inhibition training

Outcome Measures

Primary Outcomes (5)

• Number of participants recruited

  Number of participants recruited during the recruitment period in all participating clinical centers is one indicator of the feasibility of implementing substance-specific inhibition training in a smartphone app.

  From enrollment to the last assessment, approx. 16 weeks

• Number of participants successfully completing the program

  Number of participants successfully completing the program is one indicator of the feasibility of implementing substance-specific inhibition training in a smartphone app.

  At the last assessment, approx. 16 weeks from enrollment

• Proportion of participants completing the follow-up visits

  Proportion of participants completing the follow-up visits is another indicator of feasibility.

  At the last assessment, approx. 16 weeks from enrolment

• Number of participants adhering to the treatment

  Number of participants adhering to the treatment, i.e. participating in all planned twelve training sessions, is another indicator of feasibility of implementing substance-specific inhibition training in a smartphone app.

  From enrollment to last last training session, approx. 10 weeks

• Number of adverse events

  Number of adverse events is another indicator of feasibility of implementing substance-specific inhibition training in a smartphone app.

  From enrollment to the last assessment, approx. 16 weeks

Secondary Outcomes (4)

• Percentage of days abstinent

  At the last assessment, approx. 16 weeks from enrolment

• Number of heavy drinking days

  At the last assessment, approx. 16 weeks from enrolment

• P3-component of event-related potentials

  4-6 weeks.

• N2-component of event-related potentials

  4-6 weeks.

Study Arms (2)

Substance-specific inhibition training

EXPERIMENTAL

12 sessions of substance-specific inhibition training

Other: Substance-specific inhibition training

Control training

ACTIVE COMPARATOR

12 sessions of unspecific inhibition training

Other: Control training

Interventions

Substance-specific inhibition training OTHER

Twelve sessions of substance-specific inhibition training

Substance-specific inhibition training

Control training OTHER

Twelve sessions of unspecific inhibition training

Control training

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14 - 35 years
• Alcohol use disorder identification test (AUDIT) ≥ 7 or Drug Use Identification Test (DUDIT) ≥ 8
• Currently undergoing outpatient treatment or online counselling in one of 7 specialized treatment settings
• Sufficient German language skills
• Informed Consent as documented by signature
• Owner of a smartphone with internet access

You may not qualify if:

• 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
• 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
• Cochlea implant

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Maria Stein, PD Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Stein, PD Dr.

CONTACT

+41 31 684 54 12; maria.stein@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)