NCT06264791

Brief Summary

The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are:

  • Does psychological stress affect the decision to consume (more) alcohol?
  • How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 25, 2024

Last Update Submit

January 28, 2026

Conditions

Keywords

alcohol administrationstress inductionvalue-based decision-making

Outcome Measures

Primary Outcomes (1)

  • Proportion of choices for alcoholic over non-alcoholic drinks.

    Each participant will complete a two alternative forced-choice task in which they make repeated decisions between alcoholic and non-alcoholic drinks.

    5 minutes

Study Arms (4)

Stress alcohol

EXPERIMENTAL

These participants will undergo a stress induction and receive alcoholic beverages to raise their BAC to .06%

Other: StressOther: Alcohol

Stress no alcohol

EXPERIMENTAL

These participants will undergo a stress induction and receive non-alcoholic beverages

Other: Stress

No stress alcohol

EXPERIMENTAL

These participants will undergo a neutral induction and receive alcoholic beverages to raise their BAC to .06%

Other: Alcohol

No stress no alcohol

NO INTERVENTION

These participants will undergo a neutral induction and receive non-alcoholic beverages

Interventions

StressOTHER

To manipulate stress, we follow the personalized imagery script procedure developed by Sinha and colleagues. Participants randomly assigned to the stress condition will be interviewed about one week prior to the lab session. They will share a detailed description of a stressful event from their life (last 12 months) with the interviewer. Based on this interview, the experimenter will write a script (\~500 words), that will then be audiotaped. Participants will listen to this personalized audiotape during the experiment, and will be asked to imagine this event as vividly as possible. Participants randomly assigned to the no stress condition will listen to a generic audiotape that describes a non-stressful event (\~500 words). They will not be interviewed. During the lab session, participants will first complete a 3-min color counting task. The participant will then listen to the audiotape (personalized stressful audiotape in stress condition, generic non-stressful audiotape in no stress c

Stress alcoholStress no alcohol
AlcoholOTHER

Intoxication: Participants randomly assigned to the alcohol condition will be administered 100-proof Vodka mixed with orange juice (1:3 ratio) to induce a BAC of .06% (based on Widmark's formula). They will be breathalyzed every 5 minutes until they reach peak BAC, at which point they will continue with the experiment. Participants randomly assigned to the no alcohol condition will be administered water mixed with orange juice (1:3 ratio). Each participant in the no alcohol condition will be yoked to a participant in the alcohol condition and will complete the same number of breath tests. Once participants in the alcohol condition reach peak BAC and participants in the no alcohol condition performed the same number of breath tests as the participant they are yoked to, participants will continue to the stress induction.

No stress alcoholStress alcohol

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Drinking alcohol at least once a week
  • Consuming 4 (female) or 5 (male) drinks in one occasion at least once a month

You may not qualify if:

  • Currently pregnant or trying to become pregnant
  • Past or current diagnosis of an anxiety disorder, such as Generalized Anxiety Disorder or Post-Traumatic Stress Disorder
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalAlcoholic Intoxication

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Kevin M King, PhD

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 20, 2024

Study Start

February 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Anonymized data needed to reproduce our analyses will be shared on the Open Science Framework once the study has been completed.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Once data collection has been finalized and indefinitely.
Access Criteria
Everyone will be able to access the data, they will be public. All data we share are fully anonymized and not sensitive.
More information

Locations