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Episodic Future Thinking + Low-intensity Focused Ultrasound for Chronic Pain and Alcoholism
N/A
Waitlist Available
Led By Wynn Legon, 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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 21 years old or older.
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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Acute Pain Perception
Changes in Chronic Pain Severity
Changes in Delayed Discounting
Secondary outcome measures
Change in Alcohol Craving
Change in Alcohol Valuation
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
Episodic Future Thinking
2018
N/A
~450
Low-intensity Focused Ultrasound
2022
N/A
~30
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
141 Previous Clinical Trials
27,756 Total Patients Enrolled
3 Trials studying Chronic Pain
132 Patients Enrolled for Chronic Pain
Wynn Legon, PhDPrincipal InvestigatorVirginia Polytechnic and State University
4 Previous Clinical Trials
455 Total Patients Enrolled
Warren K Bickel, PhDPrincipal InvestigatorVirginia Polytechnic and State University
9 Previous Clinical Trials
1,222 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience chronic pain.I feel mentally and physically stable enough to complete a survey.I am claustrophobic, which may affect my ability to undergo scans.You cannot participate if you are pregnant.You have had a head injury that made you unconscious for more than 10 minutes.I have a condition or am on treatment that affects my brain function.You cannot have an MRI if you have a pacemaker, certain metal implants, or other metal objects in your body.I am 21 years old or older.You have been diagnosed with alcohol use disorder based on specific clinical criteria from the DSM-V, which includes having four or more symptoms related to alcohol use.I have a neurological condition like Parkinson's, Epilepsy, or Essential Tremor.
Research Study Groups:
This trial has the following groups:- Group 1: CET ad LIFU
- Group 2: EFT and LIFU
- Group 3: EFT and Sham LIFU
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment begun for this trial?
"Data on clinicaltrials.gov indicates that this medical study, which was originally posted on July 1st 2023 and last updated June 2nd 2023, is presently not recruiting patients. Nonetheless, there are still 796 other trials with open enrollment at the present moment."
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