Alcohol Use DisorderNCT03765476
Validation of a Training Program for Patients With Alcohol Use Disorder
A study testing SALIENCE and TAU in people with Alcohol Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
This study aims to detect how the Web-based program SALIENCE affects patients with alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- SALIENCE and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 65
- alcohol use disorder (DSM-5)
- inpatient or part inpatient treatment
- alcohol abstinence for at least 72 hours and maximum for three weeks
- normal or correctable eyesight
- Sufficient ability to communicate with the investigators, to answer questions in oral and written form
- "Fully Informed Consent"
- "Written Informed Consent"
Who cannot join
- Withdrawal of the declaration of consent
- severe internistic, neurological or psychiatric comorbidities
- severe withdrawal symptoms (CIWA-R > 7)
- alcohol-intoxication (> 0 ‰)
- Pharmacotherapy with psychoactive substances within the last 14 days (except Clomethiazole or Benzodiazepines within the alcohol withdrawal treatment; treatment with these medications has to be completed within last 3 days)
- Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder
This study aims to detect how the Web-based program SALIENCE affects patients with alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.
Read the detailed description
In the web-based program SALIENCE ("Stop Alcohol In Everyday life - New Choices and Evaluations") the patient has to make decisions for non-alcoholic and against alcoholic drinks. Therefore there are several scenarios, which are supposed to let the patient integrate these choices into a realistic, everyday life, setting and help the patient to maintain abstinence in upcoming "high risk situations". It has been developed as an add-on therapy to increase the overall outcome.
Participating patients with alcohol-use disorder are to receive an initial screening including questionnaires and neuropsychological tests. Then the patients receive three training sessions with SALIENCE each week.
After three weeks there is another examination. After these three weeks, there is a 90 day period in which there are online follow-ups every two weeks to assess the craving and relapse of the participants. After the 90 day period there is a third examination analog to the first and the second one.
For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an interim evaluation will be performed after T2 as a pilot study, followed by optimization of the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2 in the pilot study.
- Conditions
- Alcohol Use Disorder
- Being tested
- SALIENCE, TAU
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SALIENCEBehavioural
3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)
TAUBehavioural
treatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| TAU | Active comparator | treatment as usual Receives: Behavioral: TAU |
| TAU plus SALIENCE | Experimental | treatment as usual plus computer-based intervention "SALIENCE" Receives: Behavioral: SALIENCE; Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol craving
Visual Analogue Scale
Measured: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Change in attentional bias
Dotprobe-Task (MacLeod, Mathews, \& Tata, 1986)
Measured: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Change in alcohol interference
Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, \& Driessen, 2009)
Measured: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Change in approach-avoidance tendencies
Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)
Measured: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Secondary outcomes (1)
Relapse
time to first severe relapse
Measured: 90 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group receives add-on- intervention "SALIENCE"
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Principal investigator, ZI Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765476
- Sponsor's protocol ID
- SALIENCE
- Status last verified
- Apr 2025
- First submitted
- 23 Oct 2018
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weber A, Shevchenko Y, Gerhardt S, Hoffmann S, Kiefer F, Vollstadt-Klein S. Effectiveness of Reducing Craving in Alcohol Use Disorder Using a Serious Game (SALIENCE): Randomized Controlled Trial. JMIR Form Res. 2023 Nov 7;7:e42194. doi: 10.2196/42194.
PubMed 37934561
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03765476
- Acronym / sponsor ID
- SALIENCE
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to detect how the Web-based program SALIENCE affects patients with alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.
Detailed description
In the web-based program SALIENCE ("Stop Alcohol In Everyday life - New Choices and Evaluations") the patient has to make decisions for non-alcoholic and against alcoholic drinks. Therefore there are several scenarios, which are supposed to let the patient integrate these choices into a realistic, everyday life, setting and help the patient to maintain abstinence in upcoming "high risk situations". It has been developed as an add-on therapy to increase the overall outcome.
Participating patients with alcohol-use disorder are to receive an initial screening including questionnaires and neuropsychological tests. Then the patients receive three training sessions with SALIENCE each week.
After three weeks there is another examination. After these three weeks, there is a 90 day period in which there are online follow-ups every two weeks to assess the craving and relapse of the participants. After the 90 day period there is a third examination analog to the first and the second one.
For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an interim evaluation will be performed after T2 as a pilot study, followed by optimization of the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2 in the pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one group receives add-on- intervention "SALIENCE"
| Arm | Type | Receives |
|---|---|---|
| TAU | Active comparator | Behavioral: TAUtreatment as usual |
| TAU plus SALIENCE | Experimental | Behavioral: SALIENCE, Behavioral: TAUtreatment as usual plus computer-based intervention "SALIENCE" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age between 18 and 65
- alcohol use disorder (DSM-5)
- inpatient or part inpatient treatment
- alcohol abstinence for at least 72 hours and maximum for three weeks
- normal or correctable eyesight
Key exclusion criteria (6 listed)
- Withdrawal of the declaration of consent
- severe internistic, neurological or psychiatric comorbidities
- severe withdrawal symptoms (CIWA-R > 7)
- alcohol-intoxication (> 0 ‰)
- Pharmacotherapy with psychoactive substances within the last 14 days (except Clomethiazole or Benzodiazepines within the alcohol withdrawal treatment; treatment with these medications has to be completed within last 3 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SALIENCE3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description) | Behavioural | TAU plus SALIENCE |
| TAUtreatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions. | Behavioural | TAU, TAU plus SALIENCE |
Primary outcome
Change in alcohol craving
Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Visual Analogue Scale
Change in attentional bias
Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Dotprobe-Task (MacLeod, Mathews, \& Tata, 1986)
Change in alcohol interference
Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, \& Driessen, 2009)
Change in approach-avoidance tendencies
Time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)
1 secondary outcome
Relapse
Time frame: 90 days after study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 37934561Weber A, Shevchenko Y, Gerhardt S, Hoffmann S, Kiefer F, Vollstadt-Klein S. Effectiveness of Reducing Craving in Alcohol Use Disorder Using a Serious Game (SALIENCE): Randomized Controlled Trial. JMIR Form Res. 2023 Nov 7;7:e42194. doi: 10.2196/42194.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Vollstädt-Klein principal investigator
ZI Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SALIENCE and TAU in people with Alcohol Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol craving (time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.