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Episodic Future Thinking + Low-intensity Focused Ultrasound for Chronic Pain and Alcoholism

N/A

Recruiting

Led By Warren K Bickel, PhD

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21 years old or older

Be older than 18 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how two treatments, Episodic Future Thinking and Low-intensity Focused Ultrasound, can reduce chronic pain and alcohol use disorder symptoms.

Who is the study for?

This trial is for adults over 21 with chronic pain and alcohol use disorder, who are mentally and physically stable enough to complete a survey. They must not have unmanaged medical or psychiatric conditions, meet DSM-V criteria for alcoholism, and can't have MRI/CT contraindications like metal implants or be pregnant.

What is being tested?

The study tests how Episodic Future Thinking (EFT) and Low-intensity Focused Ultrasound (LIFU), compared to their control interventions (Episodic Recent Thinking and Sham LIFU), affect pain in people with chronic pain who also misuse alcohol.

What are the potential side effects?

While the side effects of EFT are minimal as it's a psychological intervention, LIFU may cause discomfort or mild headaches. The sham procedures should not cause any significant side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition or am on treatment that affects my brain function.

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I have a neurological condition like Parkinson's, Epilepsy, or Essential Tremor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after each intervention on two days separated by one week (eight times total).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after each intervention on two days separated by one week (eight times total).

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after each intervention on two days separated by one week (eight times total). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Acute Pain Perception

Changes in Chronic Pain Severity

Changes in Delayed Discounting

Secondary study objectives

Change in Alcohol Craving

Change in Alcohol Valuation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: EFT and Sham LIFUExperimental Treatment2 Interventions

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 II: EFT and LIFUExperimental Treatment2 Interventions

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 III: CET ad LIFUExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low-intensity Focused Ultrasound

2022

N/A

~30

Episodic Future Thinking

2018

N/A

~460