- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298658
The Impact of Insomnia on Pain in HIV (HIPPI)
The Impact of Insomnia on Pain, Physical Function, and Inflammation in HIV
Study Overview
Status
Intervention / Treatment
- Diagnostic test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised
- Diagnostic test: Resmed ApneaLink Air device (Resmed, San Diego, CA).
- Other: Quantitative Sensory testing (QST)
- Diagnostic test: Cluster of Differentiation 4 (CD4) and Viral load
- Diagnostic test: OraQuick Advance Rapid HIV 1/2 Swab test
Detailed Description
Experimental session 1 Resting Blood Pressure and Body Mass Index will be assessed. Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test. Study staff will administer the Structured Interview for Sleep Disorders and administer the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. The night of Experimental Session 1 participant will be using a Resmed ApneaLink Air device (Resmed, San Diego, CA), to identify apnea and hypopnea and calculate an apnea hypopnea index.
Between Experimental Session 1 and Experimental Session 2 Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1. Participant will be provided with a watch-like device to wear on wrist for 7 consecutive days and nights. This watch measures physical activity and sleep.
Experimental Session 2 Resting Blood Pressure and temperature will be assessed. A sample of urine will be taken to test for illicit substances that might affect the study's results. Experimental session 2 will take place in the Center for Clinical and Translational Science (CCTS) Clinical Research Unit (CRU). A clinical Research Unit (CRU) nurse will place an intravenous (IV) cannula (small plastic tube) in the arm using a needle to draw blood at the beginning of the session and then an additional four times across the study for a total of five blood draws. Participants will complete multiple questionnaires to measure health, and experience with insomnia, pain, mood and emotions, experiences with stigma and discrimination, and how participant thinks and feels about things. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 3-4 hours. Blood will be processed and stored and then used to measure inflammation.
Weekly Follow-up Sessions Participants will then complete a battery of ecologically valid movement tasks that include: 1) Performance Battery (SPPB) which includes sitting in a chair, transitioning to a standing position, balancing tests and gait speed, and the Timed Up and Go test (TUG). A clinical Research Unit (CRU) nurse will draw a quick sample of approximately 20 milliliters from the participants arm using a butterfly needle so that CRU nurse can collect blood during the beginning of each visit.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dyan M White, B.S.
- Phone Number: 2059348734
- Email: dywhite@uab.edu
Study Contact Backup
- Name: Tammie L Quinn, B.A.
- Phone Number: 2059348743
- Email: tquinn@uab.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- UAB
-
Contact:
- Tammie Quinn
- Phone Number: 205-934-8743
- Email: tquinn@uab.edu
-
Principal Investigator:
- Burel Goodin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
HIV with Insomnia
- Confirmed HIV diagnosis
- currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
- must be currently receiving stable antiretroviral therapy (ART).
- Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
HIV Without Insomnia
- Confirmed HIV diagnosis
- currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
- must be currently receiving stable antiretroviral therapy (ART).
- Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
Non HIV with Insomnia
- Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
- Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
Non HIV Without Insomnia
- Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
- Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
Exclusion Criteria:
- concurrent medical conditions that could confound
- interpretation of sleep
- pain
- inflammatory issues or coexisting diseases
- Systemic rheumatic disease/condition
- uncontrolled hypertension (i.e., BP > 150/95)
- circulatory disorders (e.g., Reynaud's disease)
- history of heart disease or cardiac events
- history of cancer
- asthma AND use of an inhaler
- history of seizures
- history of stroke or other neurological disorder
- pregnancy
- core body temperature > 100 degrees Fahrenheit as this could indicate acute infection with fever; (k)
- unwilling to provide blood for this study
- non-English speaking
- recent injury or surgical procedure within past 6 months.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HIV and Insomnia
Participants will test positive for HIV and Insomnia.
|
Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Other Names:
Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).
Other Names:
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.
|
HIV Without Insomnia
Participants will test positive for HIV and test negative for Insomnia.
|
Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Other Names:
Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).
Other Names:
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.
|
Non HIV with Insomnia
Participants will test negative for HIV and test positive for Insomnia.
|
Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Other Names:
Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).
Other Names:
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.
Other Names:
|
Non HIV Without Insomnia
Participants will test negative for HIV and test negative for Insomnia.
|
Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Other Names:
Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).
Other Names:
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pro-Inflammatory markers
Time Frame: Baseline up to 8 weeks
|
TNF-a, IL-6, IL-12, IL-18, C-reactive protein, sCD14/163, D-dimer and IFN-gamma assays will be performed on the blood to identify levels of pro-inflammatory markers.
|
Baseline up to 8 weeks
|
Anti-Inflammatory markers
Time Frame: Baseline up to 8 weeks
|
IFN-a, TGF-B, IL4, IL-10 and IL-13 assays will be performed on the blood to identify levels of anti-inflammatory markers.
|
Baseline up to 8 weeks
|
Oxidative Stress markers
Time Frame: Baseline up to 8 weeks
|
Mitochondrial DNA damage, Damage associated molecular patterns (DAMPS) and Cortisolassays will be performed on the blood to identify levels of anti-inflammatory markers.
|
Baseline up to 8 weeks
|
Pain threshold
Time Frame: Baseline up to 1 week
|
Pain threshold refers to the intensity at which a stimulus is first perceived as painful.
Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe.
From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device.
For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful"
|
Baseline up to 1 week
|
Pain tolerance
Time Frame: Baseline up to 1 week
|
Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate.
Heat stimuli will again be delivered using the computer-controlled thermal stimulation system.
From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device.
For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation.
|
Baseline up to 1 week
|
Punctate Stimuli
Time Frame: Baseline up to 1 week
|
Monofilament touch test refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate.
Participants will be asked to rate their pain after being stimulated either once or ten times with vonfrey filament, or until they can no longer tolerate" the painful sensation.
|
Baseline up to 1 week
|
Temporal summation of pain
Time Frame: Baseline up to 1 week
|
Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input.
Temporal summation is presumed to be the psychophysical manifestation of wind-up.
Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord.
A series of 5 heat pulses will be repeated every two seconds starting at a baseline temperature of 40 and participants will be asked to rate how painful each peak of the pulse feels to them using a pain rating of 0-100 (0 no pain at all to 100 the most intense pain imaginable).
These heat pulses will be repeated randomly at three different temperatures peaking at 44, 46, and 48 degrees in Celsius.
|
Baseline up to 1 week
|
Conditioned pain modulation
Time Frame: Baseline up to 1 week
|
A routinely used quantitative sensory testing protocol for the measurement of endogenous pain inhibition, which refers to the reduction in pain from one stimulus (the test stimulus) produced by the application of a second pain stimulus (the conditioning stimulus).
The conditioning stimulus will be the cold pressor task (Thermo Scientific) applied to the non-dominant hand.
For this procedure the cold water will be maintained at 10C and participants will keep their hand immersed for 60 seconds.
Upon removal of the hand, a mechanical pressure stimulus will be applied.
The pressure stimulus used is a handheld, digital pressure algometer (Algomed, Medoc, Ramat Yishai, Israel) to assess pressure pain applied to the dominant forearm and ipsilateral trapezius by gradually increasing pressure at a rate of 30 kiloPascals (maximum 1000 kiloPascals) per second until participants indicate when the increasing pressure first becomes painful by pressing a button on a device they will be holding.
|
Baseline up to 1 week
|
Actigraph Sleep Measurement
Time Frame: Baseline up to 8 weeks
|
A light weight and compact watch-like device used for objective measurement of sleep.
The device will be worn for 7 consecutive days/nights and will track physical activity, falling asleep and waking events, and includes an integrated light sensor for recording photopic light.
|
Baseline up to 8 weeks
|
Weekly Sleep Diaries
Time Frame: Baseline up to 8 weeks
|
A sleep diary including 15 daily questions will be filled out every day for seven days including questions about a participants nightly sleep experiences.
|
Baseline up to 8 weeks
|
Weekly Caffeine Diaries
Time Frame: Baseline up to 8 weeks
|
A caffeine dairy including different types of caffeine generally available for the participants to record their daily caffeine consumption of for seven days.
|
Baseline up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery
Time Frame: Week 2 up to 8 weeks
|
The SPPB consists of 3 individual sub-tests - standing balance (participants are asked to stand in 3 easy stances for 10 seconds), 4-meter gait speed (participants are asked to walk a steady pace in a straight line for 4-meters) and 5-repetition sit-to-stand (particpants are asked to stand up and sit back down in a stable chair up to 5 times).
All 3 are simple and quick to perform in the outpatient setting and require only limited equipment; participants are asked to rate difficulty 0-100 (0 no difficulty and 100 being the most difficult imaginable) and pain 0-100 (0 no pain and 100 being the most pain imaginable).
|
Week 2 up to 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go (TUG) Task
Time Frame: Week 2 up to 8 weeks
|
The Timed Up and Go test (TUG) is a commonly used screening tool to assist clinicians to identify patients at risk of falling.
Participants are asked to start in a sitting position in a chair, stand up and walk approximately 3 meters before turning to return to the chair at a steady, straight pace.
The outcome will be measured with a stopwatch, then rating difficulty 0-100 (0 no difficulty and 100 being the most difficult imaginable) and pain 0-100 (0 no pain and 100 being the most pain imaginable).
|
Week 2 up to 8 weeks
|
Munich Chrono Type Questionnaires (MCTQ)
Time Frame: Baseline
|
Consisting of 19 questions, this is a self-reported scale that is used to assess the midpoint of everyday wake and sleep schedules, as well as assessing an individual's chronotypes.
|
Baseline
|
Insomnia Severity Index (ISI)
Time Frame: Baseline up to 8 weeks
|
Using a 5-point scale and 7 questions, the ISI has each participant subjectively measure their insomnia severity.
|
Baseline up to 8 weeks
|
Demographics (DEMO)
Time Frame: Baseline
|
This questionnaire better helps the investigators understand how each participant's financial, racial, social, etc. background.
It ranges from general questions such as age and birthday, to socioeconomic questions such as work status and financial stability.
|
Baseline
|
Center for Epidemiological Studies - Depression (CESD)
Time Frame: Baseline up to 8 weeks
|
By specifically asking about the past week, this questionnaire seeks to gain a better understanding of each participant's state of mind in reference to depressive behaviors and/or feelings.
|
Baseline up to 8 weeks
|
RU Sated
Time Frame: Baseline up to 8 weeks
|
Sleep is a key aspect in an individual's everyday life.
This questionnaire measures overall sleep quality in six different categories---Regularity, Sleep quality, alertness, timing, efficiency, and duration.
This helps investigators understand a person's sleep efficacy.
|
Baseline up to 8 weeks
|
Physical Health Questionnaire (PHQ-15)
Time Frame: Baseline
|
The main goal of this questionnaire is to assess and individual's overall health status/condition.
It asks questions about a person's physical well-being, and aims to identify any illnesses they may be suffering from.
|
Baseline
|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Baseline
|
This questionnaire aims to subjectively measure the different emotions a person may be feeling, and how difficult it may be for a person to regulate those emotions.
|
Baseline
|
Dysfunctional Beliefs and Attitudes about Sleep (DBAAS)
Time Frame: Baseline
|
This questionnaire measures various sleep related attitudes and assesses beliefs about sleep that are related to insomnia.
|
Baseline
|
Pain Interference and Intensity (PI-I)
Time Frame: week 1 up to 7 weeks
|
This questionnaire seeks to understand how pain has an influence/impacts an individual's everyday life and activities, sleep, and mood in general.
|
week 1 up to 7 weeks
|
Sorge 24 Hour Food Record
Time Frame: Baseline up to 1 week
|
Tcord provides individuals with the space to write down what they've eaten in the past 24 hours, as well as what time, where they ate it, and about how much they think that they ate.
|
Baseline up to 1 week
|
Sorge Dietary Habits
Time Frame: Baseline up to 1 week
|
This questionnaire asks about a person's general diet and intake.
|
Baseline up to 1 week
|
Drug Abuse Screening Test (DAST10)
Time Frame: Baseline up to 1 week
|
This drug screening asks questions related to the consequences of drug abuse and the problems associated with it.
|
Baseline up to 1 week
|
State Trait Anxiety Inventory
Time Frame: Baseline up to 1 week
|
This psychological questionnaire aims to measure the intensity of anxiety.
It seeks to separate the state anxiety (temporary) from trait anxiety (general), as well as general anxiety and depressive feelings.
|
Baseline up to 1 week
|
Penn State Cigarette Dependence Index - Cigarettes
Time Frame: Baseline up to 1 week
|
Seeks to measure the level of addiction/dependence on smoking cigarettes.
|
Baseline up to 1 week
|
Penn State Cigarette Dependence Index - Ecigarettes
Time Frame: Baseline up to 1 week
|
Seeks to measure the level of addiction/dependence on smoking electronic cigarettes.
|
Baseline up to 1 week
|
Alcohol Use Disorders Identification Test - C (AUDIT)
Time Frame: Baseline up to 1 week
|
This questionnaire assesses alcohol consumption as well as related problems and behaviors.
|
Baseline up to 1 week
|
Alcohol Smoking and Substance Involvement Screening Test (ASSIST)
Time Frame: Baseline up to 1 week
|
This questionnaire detects and measures substance abuse, alcohol, and smoking as well as related problems.
It aims to detect the risky behavior related to each.
|
Baseline up to 1 week
|
Anger PROMIS
Time Frame: Baseline up to 1 week
|
This questionnaire measures emotions, primarily anger, relevant to the past 7 days.
|
Baseline up to 1 week
|
Perceived Stress Scale (PSS)
Time Frame: Baseline up to 1 week
|
This 14 -item self-report scale measures the degree to which an individual perceives the amount of stress in their lives.
|
Baseline up to 1 week
|
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline up to 1 week
|
This is a subjective look into how catastrophizing impacts an individual's pain.
Specifically, it aims to measure catastrophic thinking related to pain they experience during the experimental session.
|
Baseline up to 1 week
|
HIV Stigma Mechanisms
Time Frame: Baseline up to 1 week
|
This questionnaire aims to see how an individual internalizes their experiences with HIV.
Further, it asks about the negative feelings related and the beliefs associated with HIV.
|
Baseline up to 1 week
|
Heightened Vigilance Scale (HVS)
Time Frame: Baseline up to 1 week
|
Measures the different ways people anticipate experiencing discrimination in their everyday life by asking them to rate 4 items that describe how they prepare to face day to day discrimination (scale 1-6; 1 almost every day, 6 never).
|
Baseline up to 1 week
|
Experience of Discrimination (EOD)
Time Frame: Baseline up to 1 week
|
This scale evaluates each individual's experiences of discrimination.
By providing a list of reasons a person may be discriminated against, it aims to see how each individual perceives their experiences.
|
Baseline up to 1 week
|
Adverse Childhood Experiences (ACE)
Time Frame: Baseline up to 1 week
|
This questionnaire scores on a 10 point scale, and asks about childhood experiences in reference to abuse and neglect.
|
Baseline up to 1 week
|
Lee Fatigue Scale (LFS)
Time Frame: Baseline up to 1 week
|
This 0-10 rating scale aims to assess fatigue and energy over time.
|
Baseline up to 1 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Burel R Goodin, PHd, University of Alabama at Birmingham
Publications and helpful links
General Publications
- Merlin JS, Westfall AO, Heath SL, Goodin BR, Stewart JC, Sorge RE, Younger J. Brief Report: IL-1beta Levels Are Associated With Chronic Multisite Pain in People Living With HIV. J Acquir Immune Defic Syndr. 2017 Aug 1;75(4):e99-e103. doi: 10.1097/QAI.0000000000001377.
- Goodin BR, Owens MA, Yessick LR, Rainey RL, Okunbor JI, White DM, Mushatt KA, Harmon OA, Heath SL, Merlin JS. Detectable Viral Load May Be Associated with Increased Pain Sensitivity in Persons Living with HIV: Preliminary Findings. Pain Med. 2017 Dec 1;18(12):2289-2295. doi: 10.1093/pm/pnx057.
- Tenorio AR, Zheng Y, Bosch RJ, Krishnan S, Rodriguez B, Hunt PW, Plants J, Seth A, Wilson CC, Deeks SG, Lederman MM, Landay AL. Soluble markers of inflammation and coagulation but not T-cell activation predict non-AIDS-defining morbid events during suppressive antiretroviral treatment. J Infect Dis. 2014 Oct 15;210(8):1248-59. doi: 10.1093/infdis/jiu254. Epub 2014 May 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300003778
- 1R01HL147603-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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