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

Yale University

Status: Completed

Conditions: Pain Response, Stress, Trauma

Treatments: Diagnostic Test: Yale Stress Pain Test (YSPT)

Study type: Observational

Funder types: Other

Identifiers

NCT04419831

2000026626

000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

81 participants in 6 patient groups

Healthy volunteers

Description:

community volunteers

Treatment:

Diagnostic Test: Yale Stress Pain Test (YSPT)

Binge Heavy drinkers

Description:

Individuals who report regular binge alcohol intake and hazardous drinking levels

Treatment:

Diagnostic Test: Yale Stress Pain Test (YSPT)

Cannabis Use Disorder

Description:

Individuals with cannabis use disorder

Treatment:

Diagnostic Test: Yale Stress Pain Test (YSPT)

Alcohol Use Disorder

Description:

Individuals with alcohol use disorder

Treatment:

Diagnostic Test: Yale Stress Pain Test (YSPT)

Individuals with Moderate to Severe Pain

Description:

Individuals with chronic pain

Treatment:

Diagnostic Test: Yale Stress Pain Test (YSPT)

Opioid Use Disorder in medication assisted treatment

Description:

Individuals with opioid use disorder

Treatment:

Diagnostic Test: Yale Stress Pain Test (YSPT)