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

NCT04419831 | Completed

• 2 other identifiers: 2000026626000
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Response, Stress, Trauma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (6)

Healthy volunteers

community volunteers

Diagnostic Test: Yale Stress Pain Test (YSPT)

Binge Heavy drinkers

Individuals who report regular binge alcohol intake and hazardous drinking levels

Diagnostic Test: Yale Stress Pain Test (YSPT)

Cannabis Use Disorder

Individuals with cannabis use disorder

Diagnostic Test: Yale Stress Pain Test (YSPT)

Alcohol Use Disorder

Individuals with alcohol use disorder

Diagnostic Test: Yale Stress Pain Test (YSPT)

Individuals with Moderate to Severe Pain

Individuals with chronic pain

Diagnostic Test: Yale Stress Pain Test (YSPT)

Opioid Use Disorder in medication assisted treatment

Individuals with opioid use disorder

Diagnostic Test: Yale Stress Pain Test (YSPT)

Interventions

Yale Stress Pain Test (YSPT) 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; Binge Heavy drinkers; Cannabis Use Disorder; Healthy volunteers; Individuals with Moderate to Severe Pain; Opioid Use Disorder in medication assisted treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Between ages 18-50 years;
• Able to read and write English;
• 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
• Physically healthy as determined by Physical Exam, EKG and blood analyses
• Body Mass Index (BMI) in the 18-30 range;

You may not qualify if:

• Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
• Individuals taking any prescription medications or over-the counter medications regularly;
• Women with irregular menstrual cycles or who are nursing, dysmennorheic, amenorrheic, menopausal, or had premenstrual dysphoric disorder or those on birth control pills;
• Women who are pregnant as determined by the urine pregnancy test at each laboratory admission;
• Inability to give informed consent;
• Traumatic brain injury or loss of consciousness;
• Individuals with current or past history of seizure disorders

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stress hormones Cortisol and ACTH

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: April 14, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)