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

Completed

• Conditions: Pain Response, Stress, Trauma
• Interventions: Diagnostic Test: Yale Stress Pain Test (YSPT)

• Registration Number: NCT04419831
• Lead Sponsor: Yale University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Study Start: 2022-04-14
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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;

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Yale Stress Pain Test (YSPT)	community volunteers
Binge Heavy drinkers	Yale Stress Pain Test (YSPT)	Individuals who report regular binge alcohol intake and hazardous drinking levels
Individuals with Moderate to Severe Pain	Yale Stress Pain Test (YSPT)	Individuals with chronic pain
Cannabis Use Disorder	Yale Stress Pain Test (YSPT)	Individuals with cannabis use disorder
Alcohol Use Disorder	Yale Stress Pain Test (YSPT)	Individuals with alcohol use disorder
Opioid Use Disorder in medication assisted treatment	Yale Stress Pain Test (YSPT)	Individuals with opioid use disorder

Primary Outcome Measures

Name	Time	Method
Mood and anxiety assessments	3 years	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.
Food consumption	3 years	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).
Drug craving	3 years	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.
Pain assessments	3 years	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

Trial Locations

Locations (1)

Yale Stress Center; 🇺🇸 New Haven, Connecticut, United States