Alcohol Use DisorderNCT03810924
Stress-related Predictor Profiles in Human Addiction
A study testing Trier Social Stress Test, Ergometer and Barlab-Exposure in people with Alcohol Use Disorder and Stress Reaction, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Stress Reaction, Social Stress
- What is being tested?
- Trier Social Stress Test, Ergometer and Barlab-Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 8 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Alcohol-use disorder according to 2 DSM-V criteria not requiring detoxification: AUD subjects with mild AUD will fulfill at least 2 and not more than 5 diagnostic criteria; a second group of AUD subjects will fulfill 4-5 criteria for moderate AUD
- 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
- Pregnancy
- Using hormonal contraceptives
- Perimenopausal/ postmenopausal
- positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
- Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence.
Show all 9Show fewer
- Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
- History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
- Current use of medications or drugs known to interact with the CNS within at least four half-lives post last intake
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: Stress-related Predictor Profiles for Craving and Relapse in Human Addiction
Long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on measures relevant for the development and maintenance of Alcohol Use Disorder (AUD). Further, we aim to identify neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers, we will integrate innovative sensor-based measures.
Read the detailed description
In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on (1) alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity), (2) their predictive capacity for future alcohol intake, (3) the identification their neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), (4) we will integrate portable sensors (wearables) to allow a future integration in ambulatory assessments and to test innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance. Our long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.
- Conditions
- Alcohol Use Disorder, Stress Reaction, Social Stress, Craving, Relapse, Addiction
- Being tested
- Trier Social Stress Test, Ergometer, Barlab-Exposure, Reading Newspaper
- Medical subject headings
- Alcoholism, Fractures, Stress, Recurrence, Behavior, Addictive, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
Test to induce high levels of acute social stress, including actors and a faked exam situation
ErgometerBehavioural
Riding ergometer
Barlab-ExposureBehavioural
Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.
Reading NewspaperBehavioural
Participants read newspaper
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants reads newspaper before Barlab-Exposure Receives: Behavioral: Barlab-Exposure; Behavioral: Reading Newspaper |
| Experimental 1 (Distress) | Experimental | Participants undergo the Trier Social Stress Test before Barlab-Exposure Receives: Behavioral: Trier Social Stress Test; Behavioral: Barlab-Exposure |
| Experimental 2 (Eustress) | Experimental | Participants ride an ergometer before Barlab-Exposure Receives: Behavioral: Ergometer; Behavioral: Barlab-Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in heart rate
heart rate acquired with ear clip (continuous time series)
Measured: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
change in heart rate variability
heart rate variability acquired with ear clip (continuous time series)
Measured: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1 hour 50 minutes after arrival of the proband
change in blood pressure (systolic and diastolic)
acquired with pressure sleeve
Measured: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
change in electrodermal activity
time series acquired with body sensor
Measured: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband
neural alcohol-related cue-reactivity
% signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010; [% signal change is not a change over time; it is measured during one experimental session]
Measured: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
neural inhibition processing
% signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) [% signal change is not a change over time; it is measured during one experimental session]
Measured: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
neural emotion processing
% signal change, measured with fMRI; faces task (Hariri et al. 2002) [% signal change is not a change over time; it is measured during one experimental session]
Measured: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
resting state activity
resting state connectivity measured with fMRI
Measured: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
fMRI
neural alcohol-related cue-reactivity, stop-signal reaction time task, emotion processing and resting state fMRI
Measured: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
attentional bias to alcohol cues
measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) [reaction time differences is not a change over time; it is measured during one experimental session]
Measured: at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
implicit alcohol association
measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) [reaction time differences is not a change over time; it is measured during one experimental session]
Measured: at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
change in level of cortisol
cortisol measured in saliva as a stress marker
Measured: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
change in voice stress pattern
audio file of participants' voice for voice stress pattern analysis will be recorded. From this a multivariate measure (i.e. multivariate vector) will be acquired (including frequency, loudness etc.)
Measured: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
change in alcohol urges
self-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
Measured: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
change in alcohol craving
self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
Measured: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
Secondary outcomes (1)
alcohol consumption
self-report using the instrument Form90 (Scheurich et al. 2005)
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jul 2019
- Primary completion30 Sep 2022
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim
- Responsible party
- Sponsor
- Investigators
- Falk Kiefer, Prof., Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810924
- Sponsor's protocol ID
- TRR265 A03
- Status last verified
- Sep 2023
- First submitted
- 26 Nov 2018
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-related Predictor Profiles for Craving and Relapse in Human Addiction
- ClinicalTrials.gov ID
- NCT03810924
- Acronym / sponsor ID
- TRR265 A03
- Conditions
- Alcohol Use Disorder, Stress Reaction, Social Stress, Craving, Relapse, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 22 Jan 2019 (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.
Long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on measures relevant for the development and maintenance of Alcohol Use Disorder (AUD). Further, we aim to identify neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers, we will integrate innovative sensor-based measures.
Detailed description
In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on (1) alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity), (2) their predictive capacity for future alcohol intake, (3) the identification their neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), (4) we will integrate portable sensors (wearables) to allow a future integration in ambulatory assessments and to test innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance. Our long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Barlab-Exposure, Behavioral: Reading NewspaperParticipants reads newspaper before Barlab-Exposure |
| Experimental 1 (Distress) | Experimental | Behavioral: Trier Social Stress Test, Behavioral: Barlab-ExposureParticipants undergo the Trier Social Stress Test before Barlab-Exposure |
| Experimental 2 (Eustress) | Experimental | Behavioral: Ergometer, Behavioral: Barlab-ExposureParticipants ride an ergometer before Barlab-Exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alcohol-use disorder according to 2 DSM-V criteria not requiring detoxification: AUD subjects with mild AUD will fulfill at least 2 and not more than 5 diagnostic criteria; a second group of AUD subjects will fulfill 4-5 criteria for moderate AUD
- sufficient ability to communicate with the investigators, to answer questions in oral and written form
- fully informed consent
- written informed consent
Key exclusion criteria (9 listed)
- withdrawal of the declaration of consent
- Pregnancy
- Using hormonal contraceptives
- Perimenopausal/ postmenopausal
- positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
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 |
|---|---|---|
| Trier Social Stress TestTest to induce high levels of acute social stress, including actors and a faked exam situation | Behavioural | Experimental 1 (Distress) |
| ErgometerRiding ergometer | Behavioural | Experimental 2 (Eustress) |
| Barlab-ExposureParticipants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink. | Behavioural | Control, Experimental 1 (Distress), Experimental 2 (Eustress) |
| Reading NewspaperParticipants read newspaper | Behavioural | Control |
Primary outcome
change in heart rate
Time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
heart rate acquired with ear clip (continuous time series)
change in heart rate variability
Time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1 hour 50 minutes after arrival of the proband
heart rate variability acquired with ear clip (continuous time series)
change in blood pressure (systolic and diastolic)
Time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
acquired with pressure sleeve
change in electrodermal activity
Time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband
time series acquired with body sensor
neural alcohol-related cue-reactivity
Time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
% signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010; [% signal change is not a change over time; it is measured during one experimental session]
neural inhibition processing
Time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
% signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) [% signal change is not a change over time; it is measured during one experimental session]
neural emotion processing
Time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
% signal change, measured with fMRI; faces task (Hariri et al. 2002) [% signal change is not a change over time; it is measured during one experimental session]
resting state activity
Time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
resting state connectivity measured with fMRI
fMRI
Time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
neural alcohol-related cue-reactivity, stop-signal reaction time task, emotion processing and resting state fMRI
attentional bias to alcohol cues
Time frame: at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) [reaction time differences is not a change over time; it is measured during one experimental session]
implicit alcohol association
Time frame: at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) [reaction time differences is not a change over time; it is measured during one experimental session]
change in level of cortisol
Time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
cortisol measured in saliva as a stress marker
change in voice stress pattern
Time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
audio file of participants' voice for voice stress pattern analysis will be recorded. From this a multivariate measure (i.e. multivariate vector) will be acquired (including frequency, loudness etc.)
change in alcohol urges
Time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
self-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
change in alcohol craving
Time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
1 secondary outcome
alcohol consumption
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
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.
Falk Kiefer, Prof. principal investigator
Central Institute of Mental Health, 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 Trier Social Stress Test, Ergometer and Barlab-Exposure in people with Alcohol Use Disorder and Stress Reaction, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 15 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 heart rate (time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2023.