Decision Making in Chronic Pain and Alcohol Use Disorder
Key facts
- Who runs it
- Kirstin M Gatchalian
- Where
- Roanoke, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 4 people enrolled
- Started
- 28 Jun 2024
- Ended
- 31 Jul 2026
- Type of study
- Interventional, 3 groups
- Treatments tested
- Episodic Future Thinking
- Control Episodic Thinking
- Low-intensity Focused Ultrasound
- Sham Low-intensity Focused Ultrasound
- Record updated
- 14 September 2026
- Why it stopped
- personnel availability and challenges with eligibility
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 21 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
Who cannot take part
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants
- 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
- Claustrophobia (scanning environment may be uncomfortable)
- Contraindications to CT: pregnancy
Where in United States
- Fralin Biomedical Research Institute at VTCRoanoke, United States
About the trial
What the trial wants to find out
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).
The 3 groups in the trial
- EFT and LIFUOther group
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.
Treatment: Episodic Future Thinking and Low-intensity Focused Ultrasound
- EFT and Sham LIFUOther group
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.
Treatment: Episodic Future Thinking and Sham Low-intensity Focused Ultrasound
- CET ad LIFUOther group
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: Control Episodic Thinking and Low-intensity Focused Ultrasound
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 September 2026