Decision Making in Chronic Pain and Alcohol Use Disorder

NCT05901610 | Suspended FDA Device

• 1 other identifier: VT IRB# 23-561
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use Disorder; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Changes in Delayed Discounting

  Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks. Change in discounting rates will be compared after different interventions are applied.

  Before and after each intervention on two days separated by one week (eight times total).

• Changes in Acute Pain Perception

  Sensitivity to acute pain will be measured using a thermal stimulus gradually reaching 50 degrees Celsius. Participants will be asked to rate the induced pain on a visual analogue scale ranging from 0 to 10, such that greater score indicates greater pain perception. The ratings from before and after each intervention will be compared.

  Before and after each intervention on two days separated by one week (eight times total).

• Changes in Chronic Pain Severity

  Pain severity will be measured using a question from the Brief Pain Inventory. This asking requires participants to rate their pain in the last 24h from 0 to 10. Greater scores indicate greater pain severity.

  Before and after each intervention on two days separated by one week (eight times total).

Secondary Outcomes (2)

• Change in Alcohol Valuation

  Before and after each intervention on two days separated by one week (eight times total).

• Change in Alcohol Craving

  Before and after each intervention on two days separated by one week (eight times total).

Study Arms (3)

EFT and LIFU

OTHER

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.

Behavioral: Episodic Future Thinking; Device: Low-intensity Focused Ultrasound

EFT and Sham LIFU

OTHER

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.

Behavioral: Episodic Future Thinking; Device: Sham Low-intensity Focused Ultrasound

CET ad LIFU

OTHER

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.

Behavioral: Control Episodic Thinking; Device: Low-intensity Focused Ultrasound

Interventions

Episodic Future Thinking BEHAVIORAL

Participants will generate descriptions of vivid positive future events.

Also known as: EFT

EFT and LIFU; EFT and Sham LIFU

Control Episodic Thinking BEHAVIORAL

Participants will generate descriptions of vivid positive past events.

CET ad LIFU

Low-intensity Focused Ultrasound 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.

Also known as: LIFU

CET ad LIFU; EFT and LIFU

Sham Low-intensity Focused Ultrasound DEVICE

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

Also known as: Sham LIFU

EFT and Sham LIFU

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Report chronic pain
• Have sufficiently stable self-reported mental and physical health in order to complete the survey
• Meet DSM-V clinical criteria for alcohol use disorder (i.e., four or more criteria)
• Not have unmanaged medical or psychiatric conditions the survey

You may not qualify if:

• Claustrophobia (scanning environment may be uncomfortable)
• Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
• Contraindications to CT: pregnancy
• Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
• History of neurologic disorder (e.g. Parkinson's, Epilepsy, or Essential Tremor)
• History of head injury resulting in loss of consciousness for \>10 minutes
• Failure to provide a Social Security Number or Tax ID number. This is required for tax purposes.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Alcoholism; Chronic Pain

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wynn Legon, PhD

  Virginia Polytechnic and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed whether they are receiving the control behavioral intervention and Sham LIFU.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Each participant will receive all interventions throughout the study. Their pain response will be compared after episodic future thinking (EFT) with the control, episodic recent thinking (ERT) and low-intensity focused ultrasound (LIFU) with the control, Sham LIFU.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 13, 2023
• Study Start: June 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)