Alcohol Use Disorder, Chronic Pain
Conditions
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.
Interventions
BEHAVIORALEpisodic Future Thinking
Participants will generate descriptions of vivid positive future events.
BEHAVIORALControl Episodic Thinking
Participants will generate descriptions of vivid positive past events.
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.
All of the same actions done during LIFU will be performed, but the device will be inactive.
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Participants will not be informed whether they are receiving the control behavioral intervention and Sham LIFU.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Delayed Discounting | Before and after each intervention on two days separated by one week (eight times total). | 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. |
| Changes in Acute Pain Perception | Before and after each intervention on two days separated by one week (eight times total). | 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. |
| Changes in Chronic Pain Severity | Before and after each intervention on two days separated by one week (eight times total). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Valuation | Before and after each intervention on two days separated by one week (eight times total). | Intensity and elasticity of alcohol demand will be determined from an alcohol demand curve via an Alcohol Purchase Task. Change in alcohol demand will be compared within-subjects across sessions and between groups. |
| Change in Alcohol Craving | Before and after each intervention on two days separated by one week (eight times total). | Participants will be asked to complete an alcohol urges questionnaire. This questionnaire has 8 questions. Each question has a score that ranges from 1 to 7. Questions 2 and 3 have their scores reversed. The overall score ranges from 8 to 56. Greater scores indicate greater craving. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWynn Legon, PhD
Virginia Polytechnic and State University
Outcome results
None listed