Pain Response, Stress, TraumaNCT04419831
Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function
An observational study of Pain Response, Stress, Trauma, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Response, Stress, Trauma
- What is being tested?
- Yale Stress Pain Test (YSPT)
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers and those with chronic pain, those with alcohol use disorder, and those with cannabis use disorder.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive
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.
Read the 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
- Being tested
- Yale Stress Pain Test (YSPT)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | community volunteers Receives: Diagnostic Test: Yale Stress Pain Test (YSPT) | |
| Binge Heavy drinkers | Individuals who report regular binge alcohol intake and hazardous drinking levels Receives: Diagnostic Test: Yale Stress Pain Test (YSPT) | |
| Cannabis Use Disorder | Individuals with cannabis use disorder Receives: Diagnostic Test: Yale Stress Pain Test (YSPT) | |
| Alcohol Use Disorder | Individuals with alcohol use disorder Receives: Diagnostic Test: Yale Stress Pain Test (YSPT) | |
| Individuals with Moderate to Severe Pain | Individuals with chronic pain Receives: Diagnostic Test: Yale Stress Pain Test (YSPT) | |
| Opioid Use Disorder in medication assisted treatment | Individuals with opioid use disorder Receives: Diagnostic Test: Yale Stress Pain Test (YSPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start14 Apr 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Response, Stress, TraumaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419831
- Sponsor's protocol ID
- 2000026626
- Other IDs
- 000
- Status last verified
- Feb 2024
- First submitted
- 3 Jun 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive
- ClinicalTrials.gov ID
- NCT04419831
- Acronym / sponsor ID
- 2000026626
- Conditions
- Pain Response, Stress, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: Yale Stress Pain Test (YSPT)community volunteers |
| Binge Heavy drinkers | – | Diagnostic Test: Yale Stress Pain Test (YSPT)Individuals who report regular binge alcohol intake and hazardous drinking levels |
| Cannabis Use Disorder | – | Diagnostic Test: Yale Stress Pain Test (YSPT)Individuals with cannabis use disorder |
| Alcohol Use Disorder | – | Diagnostic Test: Yale Stress Pain Test (YSPT)Individuals with alcohol use disorder |
| Individuals with Moderate to Severe Pain | – | Diagnostic Test: Yale Stress Pain Test (YSPT)Individuals with chronic pain |
| Opioid Use Disorder in medication assisted treatment | – | Diagnostic Test: Yale Stress Pain Test (YSPT)Individuals with opioid use disorder |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers and those with chronic pain, those with alcohol use disorder, and those with cannabis use disorder.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Alcohol Use Disorder, Binge Heavy drinkers, Cannabis Use Disorder, Healthy volunteers, Individuals with Moderate to Severe Pain, Opioid Use Disorder in medication assisted treatment |
Primary outcome
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
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Response, Stress, Trauma, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessments (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.