Clinical trial NCT04419831: Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function
Official title: Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Response, Stress, Trauma
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Pain assessments
timeFrame: 3 years
measure: Drug craving
timeFrame: 3 years
measure: Mood and anxiety assessments
timeFrame: 3 years
measure: Food consumption
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
References: