Clinical trial NCT05901610: Decision Making in Chronic Pain and Alcohol Use Disorder
Official title: Decision Making in Chronic Pain and Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Chronic Pain
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Delayed Discounting
timeFrame: Before and after each intervention on two days separated by one week (eight times total).
measure: Changes in Acute Pain Perception
timeFrame: Before and after each intervention on two days separated by one week (eight times total).
measure: Changes in Chronic Pain Severity
timeFrame: Before and after each intervention on two days separated by one week (eight times total).
Secondary outcomes:
measure: Change in Alcohol Valuation
timeFrame: Before and after each intervention on two days separated by one week (eight times total).
measure: Change in Alcohol Craving
timeFrame: Before and after each intervention on two days separated by one week (eight times total).
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: Virginia Polytechnic and State University
name: Warren K Bickel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Polytechnic and State University
name: Wynn Legon, PhD
role: PRINCIPAL_INVESTIGATOR
References: