- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07390084
Exploring the Decision to Drink (More) Alcohol Following Manipulations of Stress and Social Context (DoraR00)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Behavioral data:
Our first set of hypotheses tests whether the decision is influenced by stress and social context:
H1a: Stress affects the decision between alcoholic and non-alcoholic drinks, so that participants in the stress conditions choose alcoholic over non-alcoholic drinks more often compared to participants in the no stress conditions.
H1b: Social context affects the decision between alcoholic and non-alcoholic drinks, so that participants in the social conditions choose alcoholic over non-alcoholic drinks more often compared to participants in the alone conditions.
H1c: We test two competing predictions:
(I) The effect of stress on the decision between alcohol and non-alcoholic drinks is modulated by social context, so that the effect of stress is stronger for participants that are in the social condition.
(II) The effect of stress on the decision between alcohol and non-alcoholic drinks is modulated by social context, so that the effect of stress is weaker for participants that are in the social condition
Drift diffusion modeling:
Our second set of hypotheses test how the decision might be influenced by stress and social context:
H2a: Stress affects the bias (but not the drift rate or boundary) parameter of the drift diffusion model, so that the bias parameter is more positive for participants in the stress conditions.
H2b: Social context affects the bias (but not the drift rate or boundary) parameter of the drift diffusion model, so that the bias parameter is more positive for participants in the social conditions.
H2c: Stress and social context have an interactive effect on the bias (but not the drift rate or boundary) parameter of the drift diffusion model, so that the bias parameter is either more or less positive for stressed participants who are in the social condition (in line with H1c).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonas Dora
- Phone Number: 2067416330
- Email: jdora@uw.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Drinking alcohol at least once a week
- Consuming 4 (female) or 5 (male) drinks in one occasion at least once a month
Exclusion Criteria:
- Currently pregnant or trying to become pregnant
- Past or current treatment for alcohol use
- Past or current medical condition that contraindicates alcohol use
- Past or current reaction to alcohol that contraindicates alcohol use
- Past or current medication that contraindicates alcohol use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stress Alone
These participants will undergo a stress induction and will make decisions about consuming alcohol alone.
|
Participants randomly assigned to the stress condition will undergo the standard protocol of the Trier Social Stress Test.
Participants randomly assigned to the control condition will undergo a validated, non-stressful control procedure mirroring the TSST.
|
|
Experimental: Stress Social
These participants will undergo a stress induction and will make decisions about consuming alcohol with a known peer.
|
Participants randomly assigned to the stress condition will undergo the standard protocol of the Trier Social Stress Test.
Participants randomly assigned to the control condition will undergo a validated, non-stressful control procedure mirroring the TSST.
Participants randomly assigned to the social condition will make decisions about consuming alcohol with a known peer.
Participants randomly assigned to the control condition will make decisions about consuming alcohol alone.
|
|
Experimental: Control Alone
These participants will undergo a control induction and will make decisions about consuming alcohol alone.
|
Participants randomly assigned to the stress condition will undergo the standard protocol of the Trier Social Stress Test.
Participants randomly assigned to the control condition will undergo a validated, non-stressful control procedure mirroring the TSST.
Participants randomly assigned to the social condition will make decisions about consuming alcohol with a known peer.
Participants randomly assigned to the control condition will make decisions about consuming alcohol alone.
|
|
Experimental: Control Social
These participants will undergo a control induction and will make decisions about consuming alcohol with a known peer.
|
Participants randomly assigned to the social condition will make decisions about consuming alcohol with a known peer.
Participants randomly assigned to the control condition will make decisions about consuming alcohol alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of choices for alcoholic over non-alcoholic drinks.
Time Frame: 5 minutes
|
Each participant will complete a two alternative forced-choice task in which they make repeated decisions between alcoholic and non-alcoholic drinks.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonas Dora, University of Washington
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00023737
- R00AA030591 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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