- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06283472
Enhancing Prospective Thinking in Early Recovery (BEAM) (BEAM)
Enhancing Prospective Thinking in Early Recovery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University School of Medicine - Goodman Hall
-
Principal Investigator:
- Brandon G Oberlin, PhD
-
Contact:
- Sarah Turo, BA
- Phone Number: 317-963-7220
- Email: sturo@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Intensity
Participants will receive high-intensity episodic future-thinking cue images, and high-intensity episodic recent-thinking cue images during an MRI decision-making task.
|
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.
|
|
Active Comparator: Low-Intensity (Control)
Participants will receive low-intensity episodic future-thinking cue images, and low-intensity episodic recent-thinking cue images during an MRI decision-making task.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed Rewards
Time Frame: Study Day Visit (Day 1)
|
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)
|
|
Increase Prospective Thinking
Time Frame: Study Day Visit (Day 1)
|
High-intensity episodic future-thinking image cues will change prospective thinking.
|
Study Day Visit (Day 1)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- 1805574553; Aims 14-16
- 2P60AA007611-403343 (Other Grant/Funding Number: National Institute on Alcohol Abuse and Alcoholism)
- 2P60AA007611 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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