Alcohol Use Disorder (AUD), Cocaine Use Disorder (CUD), Substance Use Disorder (SUD)
Conditions
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
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.
Interventions
OTHERSubstance-specific inhibition training
Twelve sessions of substance-specific inhibition training
OTHERControl training
Twelve sessions of unspecific inhibition training
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 substance-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 substance-specific inhibition training in a smartphone app. |
| 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 substance-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 substance-specific inhibition training in a smartphone app. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 consumption 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 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 |
| N2-component of event-related potentials | 4-6 weeks. | 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 |
Countries
Switzerland
Contacts
CONTACTMaria Stein, PD Dr.
PRINCIPAL_INVESTIGATORMaria Stein, PD Dr.
University of Bern
Outcome results
None listed