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Decision Making in Chronic Pain and Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder, Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Episodic Future Thinking
Episodic Recent Thinking
Low-intensity Focused Ultrasound
Sham Low-intensity Focused Ultrasound
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Fralin Biomedical Research Institute at VTC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ERT and LIFU

EFT and Sham LIFU

Arm Description

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. 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.

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 Sham LIFU, the device will be set up identically as in real LIFU. However, the device will be turned off.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change in Alcohol Valuation
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
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.

Full Information

First Posted
June 2, 2023
Last Updated
July 11, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT05901610
Brief Title
Decision Making in Chronic Pain and Alcohol Use Disorder
Official Title
Decision Making in Chronic Pain and Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 two intervention sessions. Specifically, participants will complete two experimental conditions (episodic future thinking; EFT and low-intensity focused ultrasound; LIFU), as well as their respective control conditions (episodic recent thinking; ERT and sham ultrasound). Measures of acute and chronic pain, alcohol valuation, alcohol craving, and delay discounting will be collected after each experimental and control condition. The EFT intervention generates 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 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. The control condition for EFT (i.e., ERT) requires participants to think about and describe positive events that occurred at each of 64 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. Finally, the sham LIFU condition may be active with ultrasound blocking, or inactive so that it would not deliver stimulation. All participants will complete all conditions on three different days. First day will be the consent and baseline session, and the remaining two experimental sessions will be in a counterbalanced order. EFT and LIFU will be employed in one session, and ERT and Sham LIFU in a different session. The first and second session will be separated by 2-3 weeks, and the second and third by approximately 1 week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Chronic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Participants will not be informed whether they are receiving the control behavioral intervention and Sham LIFU.
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERT and LIFU
Arm Type
Other
Arm Description
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. 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.
Arm Title
EFT and Sham LIFU
Arm Type
Other
Arm Description
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 Sham LIFU, the device will be set up identically as in real LIFU. However, the device will be turned off.
Intervention Type
Behavioral
Intervention Name(s)
Episodic Future Thinking
Other Intervention Name(s)
EFT
Intervention Description
Participants will generate descriptions of vivid positive future events.
Intervention Type
Behavioral
Intervention Name(s)
Episodic Recent Thinking
Intervention Description
Participants will generate descriptions of vivid positive past events.
Intervention Type
Device
Intervention Name(s)
Low-intensity Focused Ultrasound
Other Intervention Name(s)
LIFU
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Low-intensity Focused Ultrasound
Other Intervention Name(s)
Sham LIFU
Intervention Description
All of the same actions done during LIFU will be performed, but the device will be inactive.
Primary Outcome Measure Information:
Title
Changes in Delayed Discounting
Description
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.
Time Frame
Before and after each intervention on two days separated by one week (eight times total).
Title
Changes in Acute Pain Perception
Description
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.
Time Frame
Before and after each intervention on two days separated by one week (eight times total).
Title
Changes in Chronic Pain Severity
Description
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.
Time Frame
Before and after each intervention on two days separated by one week (eight times total).
Secondary Outcome Measure Information:
Title
Change in Alcohol Valuation
Description
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.
Time Frame
Before and after each intervention on two days separated by one week (eight times total).
Title
Change in Alcohol Craving
Description
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.
Time Frame
Before and after each intervention on two days separated by one week (eight times total).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Gatchalian
Phone
540-526-2071
Email
kmgatch@vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren K Bickel, PhD
Organizational Affiliation
Virginia Polytechnic and State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wynn Legon, PhD
Organizational Affiliation
Virginia Polytechnic and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fralin Biomedical Research Institute at VTC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Glenn
Phone
540-526-2014
Email
sglenn@vtc.vt.edu

12. IPD Sharing Statement

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Decision Making in Chronic Pain and Alcohol Use Disorder

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