Trials / Completed
CompletedNCT03810924
Stress-related Predictor Profiles in Human Addiction
Stress-related Predictor Profiles for Craving and Relapse in Human Addiction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Central Institute of Mental Health, Mannheim · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Trier Social Stress Test | Test to induce high levels of acute social stress, including actors and a faked exam situation |
| BEHAVIORAL | Ergometer | Riding ergometer |
| BEHAVIORAL | Barlab-Exposure | Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink. |
| BEHAVIORAL | Reading Newspaper | Participants read newspaper |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2022-09-30
- Completion
- 2023-07-08
- First posted
- 2019-01-22
- Last updated
- 2023-09-15
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03810924. Inclusion in this directory is not an endorsement.