Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function

Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive

The study design is to assess the between groups factor (controls, chronic pain, addicted individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a longitudinal component to assess stress, pain and addictive behaviors in daily life.

Study Overview

• Status: Completed
• Conditions: Pain Response, Stress, Trauma
• Intervention / Treatment: Diagnostic test: Yale Stress Pain Test (YSPT)

Detailed Description

This proposal aims to systematically examine the physiologic, neuroendocrine and behavioral stress and pain responses to an adapted Cold Pressor Test and also assess specific cognitive and executive function tests in community volunteers with a history of stress and trauma, social users of alcohol, cannabis and individuals with alcohol use disorder, cannabis use disorder, opioid use disorder, cocaine use disorder and chronic pain.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

• Study Contact: Name: RAJITA SINHA; Phone Number: 1203737-5805; Email: rajita.sinha@yale.edu
• Study Contact Backup: Name: Rachel Hart, MA; Phone Number: 1203-737-4791; Email: rachel.hart@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Stress Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and those with chronic pain, those with alcohol use disorder, and those with cannabis use disorder.

Description

Inclusion Criteria:

1. Between ages 18-50 years;
2. Able to read and write English;
3. 50 individuals meeting DSM V criteria for Binge Heavy drinkers, using NIAAA criteria for alcohol intake 50 individuals meeting DSM V criteria for Cannabis Use Disorder 50 individuals meeting DSM V criteria for Alcohol Use Disorder 50 Individuals with Moderate to Severe Pain 50 individuals meeting DSM V criteria for Opioid Use Disorder who are initiating treatment
4. Physically healthy as determined by Physical Exam, EKG and blood analyses
5. Body Mass Index (BMI) in the 18-30 range;

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
2. Any Current Substance Use Disorder including alcohol, cannabis, cocaine, opioids, sedatives/hypnotics. For alcohol, cannabis, and opioid subjects, exclusion for the abused drug will not apply.
3. Individuals taking any prescription medications or over-the counter medications regularly;
4. Women with irregular menstrual cycles or who are nursing, dysmennorheic, amenorrheic, menopausal, or had premenstrual dysphoric disorder or those on birth control pills;
5. Women who are pregnant as determined by the urine pregnancy test at each laboratory admission;
6. Inability to give informed consent;
7. Traumatic brain injury or loss of consciousness;
8. Individuals with current or past history of seizure disorders

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; community volunteers	Diagnostic test: Yale Stress Pain Test (YSPT); Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion
Binge Heavy drinkers; Individuals who report regular binge alcohol intake and hazardous drinking levels	Diagnostic test: Yale Stress Pain Test (YSPT); Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion
Cannabis Use Disorder; Individuals with cannabis use disorder	Diagnostic test: Yale Stress Pain Test (YSPT); Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion
Alcohol Use Disorder; Individuals with alcohol use disorder	Diagnostic test: Yale Stress Pain Test (YSPT); Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion
Individuals with Moderate to Severe Pain; Individuals with chronic pain	Diagnostic test: Yale Stress Pain Test (YSPT); Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion
Opioid Use Disorder in medication assisted treatment; Individuals with opioid use disorder	Diagnostic test: Yale Stress Pain Test (YSPT); Yale Stress Pain Test involves 10 minutes exposure to 3 cycles of ice cold bucket hand immersion (stress) or 3 cycles of warm water immersion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessments	Pain will be assessed by asking participants, "Right now, how much pain do you feel?" asked using the VAS scale ranging from 0 to 100 as outlined in the Laboratory Pain Ratings assessment	3 years
Drug craving	Drug craving will be assessed by asking participants, "Right now, how much do you want to use your preferred drug?" This item will be presented in all assessments throughout the study period. Participants will be asked, "How much drug did you use in drinks/grams," that day in the evening prompt and in the previous day in the evening prompt.	3 years
Mood and anxiety assessments	The Positive and Negative Affect Schedule (PANAS) measures positive and negative mood and anxiety measures during the initial 28-day period. Participants respond to a 20-item test using a 5-point scale ranging from very slightly or not at all (1) to extremely (5) on the EMA.	3 years
Food consumption	Food consumption will be assessed via the evening survey during the initial 28-day period. Participants will respond with the top three types of food that they ate (e.g., "vegetables/salad", "sweet food/dessert", "white meat (e.g., fish/chicken)") and to what extent did they continue eating after feeling full (1=Not at all, 100=Very much).	3 years

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2000026626; 000 (Other Identifier: CTGTY)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No