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Completed

NCT Number: NCT04419831

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

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.

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Key information

Conditions

Pain Response, Stress, Trauma Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale Stress Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
  • 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.
  • 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

Treatment and study plan

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

Primary outcomes

  1. Pain assessments

    Time frame: 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

  2. Drug craving

    Time frame: 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.

  3. Mood and anxiety assessments

    Time frame: 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.

  4. Food consumption

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2020
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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