Decision Making in Chronic Pain and Alcohol Use Disorder

NCT ID: NCT05901610

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

CET ad LIFU

Participants will generate positive recent past events that have happened to them at several time points in the previous day (e.g., 7pm-10pm, 4pm-7pm, 1pm-4pm, 10am-1pm, and 7am-10am). 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 using the imaging collected during visit 1.

Group Type: OTHER

Control Episodic Thinking

Intervention Type: BEHAVIORAL

Participants will generate descriptions of vivid positive past events.

Low-intensity Focused Ultrasound

Intervention Type: DEVICE

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.

EFT and LIFU

Participants will generate positive future events they are looking forward to at several time points in the future (e.g., 2 weeks, 1 month, 3 months, 1 year, and 5 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 using the imaging collected during visit 1. A small amount of ultrasound gel will be placed on the face of the single-element focused ultrasound transducer. The transducer will then be fitted on the scalp over the desired brain area and held in place with a mechanical arm. Brief pulses (0.2 to 2 seconds; duty cycle 10 - 70%; pulse repetition frequency 100 - 1000 Hz) of low-intensity (\< 50 W/cm2 Isppa), sub-thermal ultrasound (0.3 - 0.5 MHz) will be delivered in order to determine the area of activation, as well as the patterns of brain activity generated.

Group Type: OTHER

Episodic Future Thinking

Intervention Type: BEHAVIORAL

Participants will generate descriptions of vivid positive future events.

Low-intensity Focused Ultrasound

Intervention Type: DEVICE

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.

EFT and Sham LIFU

Participants will generate positive recent past events that have happened to them at several time points in the previous day (e.g., 7pm-10pm, 4pm-7pm, 1pm-4pm, 10am-1pm, and 7am-10am). During Sham LIFU, the device will be set up identically as in real LIFU. However, the device will be turned off.

Group Type: OTHER

Episodic Future Thinking

Intervention Type: BEHAVIORAL

Participants will generate descriptions of vivid positive future events.

Sham Low-intensity Focused Ultrasound

Intervention Type: DEVICE

All of the same actions done during LIFU will be performed, but the device will be inactive.

Interventions

Episodic Future Thinking

Participants will generate descriptions of vivid positive future events.

Intervention Type: BEHAVIORAL

Control Episodic Thinking

Participants will generate descriptions of vivid positive past events.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Sham Low-intensity Focused Ultrasound

All of the same actions done during LIFU will be performed, but the device will be inactive.

Intervention Type: DEVICE

Other Intervention Names

EFT; LIFU; Sham LIFU

Eligibility Criteria

Inclusion Criteria

1. 21 years old or older

2. Report chronic pain

3. Have sufficiently stable self-reported mental and physical health in order to complete the survey

4. Meet DSM-V clinical criteria for alcohol use disorder (i.e., four or more criteria)

5. Not have unmanaged medical or psychiatric conditions the survey

Exclusion Criteria

1. Claustrophobia (scanning environment may be uncomfortable)

2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

3. Contraindications to CT: pregnancy

4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)

5. History of neurologic disorder (e.g. Parkinson's, Epilepsy, or Essential Tremor)

6. History of head injury resulting in loss of consciousness for >10 minutes

7. Failure to provide a Social Security Number or Tax ID number. This is required for tax purposes.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Stephen LaConte

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wynn Legon, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic and State University

Locations

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

VT IRB# 23-561

Identifier Type: -

Identifier Source: org_study_id