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

NCT ID: NCT04419831

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2023-12-30

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.

Conditions

Pain Response, Stress, Trauma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

community volunteers

Yale Stress Pain Test (YSPT)

Intervention Type: DIAGNOSTIC_TEST

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

Yale Stress Pain Test (YSPT)

Intervention Type: DIAGNOSTIC_TEST

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

Yale Stress Pain Test (YSPT)

Intervention Type: DIAGNOSTIC_TEST

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

Yale Stress Pain Test (YSPT)

Intervention Type: DIAGNOSTIC_TEST

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

Yale Stress Pain Test (YSPT)

Intervention Type: DIAGNOSTIC_TEST

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

Yale Stress Pain Test (YSPT)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale Stress Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000026626

Identifier Type: -

Identifier Source: org_study_id