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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06283472
Other study ID # 1805574553; Aims 14-16
Secondary ID 2P60AA007611-403
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date February 1, 2027

Study information

Verified date June 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question[s] this trial aims to answer are: - Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? - Will high-intensity EFT cues effect greater treatment-seeking interest? - Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) - Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? - Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals who meet current heavy drinking (=2 heavy drinking days/month OR =7 drinks/week for biological females, and =14 drinks/week if biological male [NIAAA definition] and/or AUDIT scores =8) - English comprehension Exclusion Criteria: - Unstable medical disorders - Outside the age range of 18-60 - Smell/taste disorders - Unstable psychiatric conditions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High-Intensity Cue
Participants in the high-intensity group will receive high-intensity image cues that represent self-reported events they did on the previous day and self-reported events they look forward to in the future.
Low-Intensity Cue
Participants in the low-intensity group will receive low-intensity image cues that represent self-reported events they did on the previous day and self-reported events they look forward to in the future.

Locations

Country Name City State
United States Indiana University School of Medicine - Goodman Hall Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase Prospective Thinking High-intensity episodic future-thinking image cues will change prospective thinking. Study Day Visit (Day 1)
Primary Delayed Rewards High-intensity episodic future-thinking image cues will change preference for delayed rewards, which will be measured using a behavioral delayed discounting task. Study Day Visit (Day 1)
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