NCT05901610

Decision Making in Chronic Pain and Alcohol Use Disorder

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The objective of this within-subject study is to test the effects of Episodic Future Thinking (EFT) and Low-intensity Focused Ultrasound (LIFU) interventions on the pain of subjects who have chronic pain and alcohol use disorder(s).

Detailed description

This study will have a within-subject design. Participants will complete a baseline session (S1) and three intervention sessions. Specifically, participants will complete one intervention session consisting of episodic future thinking (EFT) and low-intensity focused ultrasound (LIFU), a second intervention session consisting of EFT and a control condition for LIFU ("sham-LIFU"), and an intervention session consisting of a control condition for EFT, called control episodic thinking (CET) and LIFU. Measures of chronic pain, alcohol valuation, alcohol craving, and delay discounting will be collected before and after each intervention session. The EFT intervention has participants generate positive events and related cues through a researcher-administered interview-based questionnaire. Participants will be asked to think about and describe positive events that could occur at each of the 6 delays in the future (i.e., 1 week, 1 month, 3 months, 1 year, 5 years, and 25 years). During the LIFU condition, participants will have an ultrasound transducer placed on their head, where brief ultrasound pulses are delivered to the desired brain area. CET requires participants to think about and describe positive events that occurred at each of 6 delays in the past (e.g., last night, yesterday in the afternoon, yesterday in the evening, yesterday in the morning, yesterday in the night, and the night before). After generating these cues participants will be asked to read and consider their cues as they complete the measures again that were collected prior to the cue generation. The sham LIFU condition may be active with ultrasound blocking, or inactive so that it would not deliver stimulation. All participants will complete all three intervention sessions. The first day will be the consent, MRI, and CT scans required for the LIFU intervention. The remaining three intervention sessions will occur in a counterbalanced order. The first and second sessions will be separated by 2-3 weeks, and the remaining sessions will be separated by approximately 1 week.

Conditions

• Alcohol Use Disorder
• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	Episodic Future Thinking	Participants will generate descriptions of vivid positive future events.
BEHAVIORAL	Control Episodic Thinking	Participants will generate descriptions of vivid positive past events.
DEVICE	Low-intensity Focused Ultrasound	A transducer device will use focused ultrasound energy to neuromodulate the insular cortex. The participant's brain will be mapped based on information from the CT and MRI scans, and the transducer will deliver brief ultrasound pulses to the insular cortex.
DEVICE	Sham Low-intensity Focused Ultrasound	All of the same actions done during LIFU will be performed, but the device will be inactive.

Timeline

• Start date: 2024-06-28
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-06-13
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study