Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-35
SponsorUniversity of Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Substance-specific inhibition training
Other interventionTwelve sessions of substance-specific inhibition training
Control training
Other interventionTwelve sessions of unspecific inhibition training
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Substance-specific inhibition trainingExperimental treatment 1 intervention
Group B: Control trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the last assessment, approx. 16 weeks2
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.
Time frame
At the last assessment, approx. 16 weeks from enrollment3
Proportion of participants completing the follow-up visits
Proportion of participants completing the follow-up visits is another indicator of feasibility.
Time frame
At the last assessment, approx. 16 weeks from enrolment4
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.
Time frame
From enrollment to last last training session, approx. 10 weeksSecondary outcomes
1
Percentage of days abstinent
Percentage of days abstinent is the main secondary outcome indicating preliminary effects on consumption behavior. It is measured by the Timeline Follow-Back method at 3-month follow-up.
Time frame
At the last assessment, approx. 16 weeks from enrolment2
Number of heavy drinking days
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.
Time frame
At the last assessment, approx. 16 weeks from enrolment3
P3-component of event-related potentials
The P3-component of event-related potentials measured with electroencephalography (EEG) is used as a secondary outcome in the EEG- substudy to investigate whether substance-specific inhibition training modifies the neurophysiology of substance-specific inhibition
Time frame
4-6 weeks.4
N2-component of event-related potentials
The N2-component of event-related potentials measured with electroencephalography (EEG) is used as a secondary outcome in the EEG- substudy to investigate whether substance-specific inhibition training modifies the neurophysiology of substance-specific inhibition
Time frame
4-6 weeks.Sponsors and contacts
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Source ClinicalTrials.gov