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Trial record 30 of 274 for:    personality AND therapy AND Personality | Recruiting, Not yet recruiting, Available Studies

Imaging Biomarker for Addiction Treatment Outcome

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ClinicalTrials.gov Identifier: NCT03427424
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

Brief Summary:

Background:

Many people suffer from drug addiction. But currently, treatments are not very effective. One group of patients in this study are enrolled in addiction treatment through physician health programs (PHPs). About 70% of these patients are able to stop using drugs for extended periods of time. By studying this specific group of patients, researchers want to understand the difference between those who may or may not respond to treatment. They want to study the brain while people do thinking and feeling tasks and when they relax. They will study brain chemicals, a stress hormone, and certain genes. The results may help them understand the brain basis for addiction and recovery.

Objectives:

To use brain imaging to find differences between people with and without drug addiction. To see if these differences help predict addiction.

Eligibility:

Healthy, right-handed adults ages 25-65, enrolled in a physician health program or those with no history of addiction and with at least 16 years of education

Design:

Participants enrolled in a PHP will be screened under this study and participants with no history of addiction will be screened under another study.

At the study visit, participants will:

Have a routine check-up, including tests for pregnancy, drugs, and alcohol.

Give 11 blood samples.

Rate their cravings.

Test their frustration with stressful situations by responding to questions on a screen.

Practice the magnetic resonance imaging (MRI) tasks:

Shock task. Two electrodes placed on a foot will deliver brief, low-strength electrical shocks that get gradually stronger, but not painful. Participants will see drug or neutral images. They will rate their discomfort.

Thinking tasks. Participants will answer questions about pictures, numbers, and money. They will press buttons in response to things they see.

Do the MRI tasks in 2 sessions (morning and afternoon) in the scanner. Participants will lie in an MRI machine which will take pictures of the brain while doing these tasks.

Some participants will repeat the visit twice over a year at set intervals.

Meals will be provided, and visits will include meal breaks and smoking breaks for those who smoke.


Condition or disease
Opioid-Related Disorders Alcohol-Related Disorders

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Imaging Biomarker for Addiction Treatment Outcome
Estimated Study Start Date : September 18, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
AUD-E
Early-in-treatment, healthy alcohol use disorder participants currently enrolled in PHPs within about 2 month of starting treatment (AUD-E),
AUD-L
Long-term-in-treatment, healthy alcohol use disorder participants currently enrolled in PHPs more than 2 months and less than 5 years (AUD-L),
CON
healthy, non-drug using control participants (CON)
POAUD-E
Early-in-treatment, healthy dual prescription opioid and alcohol use disorder participants currently enrolled in PHPs within 2 month of starting treatment (POAUD-E),
POAUD-L
Long-term-in-treatment, healthy dual prescription opioid and alcohol use disorder participants currently enrolled in PHPs more than 2 months and less than 5 years (POAUD-L).
POUD-E
Early-in-treatment, healthy prescription opioid use disorder participants currently enrolled in physician health programs (PHP) within about 2 month of starting treatment (POUD-E),
POUD-L
Long-term-in-treatment, healthy prescription opioid use disorder participants currently enrolled in PHPs more than 2 months and less than 5 years (POUD-L),



Primary Outcome Measures :
  1. For cross-sectional study will be differences in functional connectivity and BOLD signal activation in executive and impulsive neurobehavioral decision systems at various stages of sobriety in relation to controls [ Time Frame: 1 study visit ]
    For cross-sectional study will be differences in functional connectivity and BOLD signal activation in executive and impulsive neurobehavioral decision systems at various stages of sobriety in relation to controls

  2. For the longitudinal study will be differences in baseline and changes over time in functional connectivity circuits, BOLD signal activation in executive and impulsive neurobehavioral decision systems between abstinent and relapsing addicts that... [ Time Frame: 6 and 12 mo f/u visits ]
    For the longitudinal study will be differences in baseline and changes over time in functional connectivity circuits, BOLD signal activation in executive and impulsive neurobehavioral decision systems between abstinent and relapsing addicts that can predict treatment response at 6 and 12 months.


Secondary Outcome Measures :
  1. Phenotypic (performance on behavioral tasks, self-reported measures of cravings, impulsivity and personality traits), genotypic and imaging (structural and spectroscopy) differences between different addiction groups. [ Time Frame: At each visit ]
    Secondary Outcome Measure: Phenotypic (performance on behavioral tasks, self-reported measures of cravings, impulsivity and personality traits), genotypic and imaging (structural and spectroscopy) differences between different addiction groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cross-sectional study will include participants enrolled at a PHP over the past 5 years and have been in treatment for more than 2 months.@@@Longitudinal study will include participants who are enrolled at a PHP within about two months of starting treatment.@@@No preferences in participant recruitment will be made on the bases of gender, race, or ethnic background. Efforts will be made to include minorities in proportion to their presence in the local population of the PHP. The demographic profile for the PHP cohort is about 60% males (Braquehais et al. 2014; Brooks et al. 2013), predominantly Caucasian; 89% and about 4% Asian, 3% Hispanic, 1.5% African American and 1.5% other races (Brooks et al. 2013). The matching control group will be @@@recruited from NIH employees and from the major metropolitan Baltimore area.
Criteria
  • INCLUSION CRITERIA:

All participants: (CON), (POUD-E), (POUD-L), (AUD-E), (AUD-L), (POAUD-E), (POAUD-L):

  • Males and females between 25-65 years of age will be enrolled in the study. Justification: The lower age cut off is chosen because the sample consists of addicted physicians who are all above 25 years of age. The upper age cut off is chosen because of aging-related brain changes that could confound the results. Assessment tool: Participants self-report their demographic information, including date of birth.
  • Able and willing to provide written informed consent. Justification: It is important for subjects to understand and agree to all the procedures, time-commitments and expectations entailed in this study. Assessment tool: Verbal confirmation of willingness to consent and a score of 80% or more on consent quiz.
  • Must be right-handed. Justification: Some of the neural processes assessed in this protocol may be lateralized in the brain. In order to reduce potential variance, participants will be required to be righthanded. Assessment tool: Edinburgh Handedness Inventory.
  • Participants must be in good health. Justification: Many illnesses may alter fMRI signals as well as neural functioning. Assessment tool(s): Control participants will undergo a medical history and physical examination. Experimental group participants will provide a brief health history during phone/internet screening. Written physician health records will also be obtained to verify health status of the experimental groups.

HEALTHY CONTROL PARTICIPANTS (CON) IN ADDITION TO ALL PARTICIPANTS' INCLUSION CRITIERIA:

  • Free of lifetime DSM-5 substance use disorders except for tobacco use disorder. Justification: the presence of substance use disorder in the control group will confound the results. Please note we exempted tobacco use disorder in order to match the experimental group participants. Assessment tool(s): The MINI and clinical assessment.
  • 16 years of education or more Justification: To match the educational status of the experimental group. Assessment tool: Participant will provide educational history.

Early-in-treatment, prescription opioid use disorder (POUD-E) participants- in addition to all participants inclusion criteria:

  1. Recently (within about 2 months) enrolled in a physician health program (PHP) or equivalent at time of enrollment in the study Justification: The two months interval was chosen because we wish to longitudinally follow participants from very early abstinence to long-term abstinence/relapse at one year. Importantly, participants are allowed to leave residential treatment centers and go home for weekends or short holidays after two months of starting treatment, so inviting enrolled participants to travel to NIDA IRP for one-day visit after two months of treatment is not expected to increase their risk of relapse. Assessment tool: addiction treatment records.
  2. Meet a minimum of 6/11 DSM-5 criteria for severe opioid use disorder (OUD) for at least 2 years prior to enrollment and in full remission for at least 2 months at time of imaging. Justification: The hypothesized differences in measured brain imaging parameters are more likely to be detected in severe OUDs compared to mild or moderate OUDs. Assessment tool: DSM 5 Opioid Use Disorder

Checklist.

Early-in-treatment, alcohol use disorder (AUD-E) participants- in addition to all participants inclusion criteria:

  1. Recently (within about 2 months) enrolled in a physician health program (PHP) or equivalent at time of enrollment in the study Justification: The two months interval was chosen because we wish to follow longitudinally participants from very early abstinence to long-term abstinence/ relapse at one year. Importantly, participants are allowed to leave residential treatment centers and go home for weekends or short holidays after two months of starting treatment, therefore, inviting enrolled participants to travel to NIDA IRP for one-day visit after two months of treatment is not expected to increase their risk of relapse. Assessment tool: addiction treatment records.
  2. Meet a minimum of 6/11 DSM-5 criteria for severe alcohol use disorder (AUD) for at least 2 years prior to enrollment and in full remission for at least 2 months at time of imaging. Justification: The hypothesized differences in measured brain imaging parameters are more likely to be detected in severe AUDs compared to mild or moderate AUDs. Assessment tool: DSM 5 Alcohol Use Disorder

Checklist.

Early-in-treatment, dual prescription opioid and alcohol use disorder (POAUD-E) participants- in addition to all participants inclusion criteria:

  1. Recently (within about 2 months) enrolled in a physician health program (PHP) or equivalent at time of enrollment in the study Justification: The two months interval was chosen because we wish to follow longitudinally participants from very early abstinence to long-term abstinence/ relapse at one year. Importantly, participants are allowed to leave residential treatment centers and go home for weekends or short holidays after two months of starting treatment, therefore, inviting enrolled participants to travel to NIDA IRP for one-day visit after two months of treatment is not expected to increase their risk of relapse. Assessment tool: addiction treatment records.
  2. Meet a minimum of 6/11 DSM-5 criteria for either severe opioid or severe alcohol use disorders and a minimum of 4/11 DSM-5 for either moderate opioid or moderate alcohol use disorder at least 2 years for each substance prior to enrollment and in full remission for at least 2 months at time of imaging. Justification: The hypothesized differences in measured brain imaging parameters are more likely to be detected in severe SUDs compared to mild or moderate SUDs, so at least one of the two dual addictions should be severe and the second one can be moderate. Assessment tool: DSM 5 Opioid Use Disorder and Alcohol Use Disorder Checklists.

Long-term-in-treatment, prescription opioid use disorder (POUD-L) participants- in addition to all participants inclusion criteria:

  1. Enrolled in a physician health program (PHP) or equivalent for more than 2 months and less than 5 years at time of enrollment in the study Justification: The more than two months and less than 5 years interval was chosen because we wish to study brain changes (compared to non-drug using controls) at different stages of abstinence. Assessment tool: addiction treatment records.
  2. Meet a minimum of 6/11 DSM-5 criteria for severe opioid use disorder for at least 2 years prior to starting treatment and in full remission for at least 2 months at time of imaging. Justification: The hypothesized differences in measured brain imaging parameters are more likely to be detected in severe OUD compared to mild or moderate OUDs. Assessment tool: DSM 5 Opioid Use Disorder Checklist.

Long-term-in-treatment, alcohol use disorder (AUD-L) participants- in addition to all participants inclusion criteria:

  1. Enrolled in a physician health program (PHP) or equivalent for more than 2 months and less than 5 years at time of enrollment in the study and in full remission for at least 2 months at time of imaging. Justification: The more than two months and less than 5 years interval was chosen because we wish to study brain changes (compared to non-drug using controls) at different stages of abstinence. Assessment tool: addiction treatment records.
  2. Meet a minimum of 6/11 DSM-5 criteria for severe alcohol use disorder for at least 2 years prior to starting treatment. Justification: The hypothesized differences in measured brain imaging parameters are more likely to be detected in severe AUD compared to mild or moderate AUDs. Assessment tool: DSM 5 Alcohol Use Disorder Checklist.

Long-term-in-treatment, dual prescription opioid and alcohol use disorder (POAUD-L) participants - in addition to all participants inclusion criteria:

  1. Enrolled in a physician health program (PHP) or equivalent for more than 2 months and less than 5 years at time of enrollment in the study Justification: The more than two months and less than 5 years interval was chosen because we wish to study brain changes (compared to non-drug using controls) at different stages of abstinence. Assessment tool: addiction treatment records.
  2. Meet a minimum of 6/11 DSM-5 criteria for either severe opioid or severe alcohol use disorder and a minimum of 4/11 DSM-5 for either moderate opioid or moderate alcohol use disorder at least 2 years for each substance prior to enrollment and in full remission for at least 2 months at time of imaging. Justification: The hypothesized differences in measured brain imaging parameters are more likely to be detected in severe SUDs compared to mild or moderate SUDs, so at least one of the two dual addictions should be severe and the second one can be moderate. Assessment tool: DSM 5 Opioid Use Disorder and Alcohol Use Disorder Checklists.

EXCLUSION CRITIERIA:

All participants: (CON), (POUD-E), (POUD-L), (AUD-E), (AUD-L), (POAUD-E), (POAUD-L):

  1. Females must not be pregnant or lactating. Justification: The impact of exposing pregnant females to MRI and stress paradigms is unknown. Including lactating females will confound the results because of the effect of lactation-associated hormonal changes on the brain. Assessment: medical history and negative urine pregnancy test prior to each MRI visit (and at screening for control participants).
  2. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (e.g. pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces. Justification: The presence of ferromagnetic objects poses risk of injury during MRI. Assessment tool: medical history and MRI screening form.
  3. Noise-induced hearing loss or tinnitus. Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by MRI scanner. Assessment tool: medical history and MRI safety screening. 4. Head trauma with loss of consciousness or significant sequelae for more than 30 minutes. Justification: The presence of head injury could result in subtle alterations in brain structure or function and could confound the results. Assessment tool: medical history and physical exam (controls).

5. Current or past DSM-5 diagnosis of any psychiatric disorder that required hospitalization other than detoxification (any length), or chronic medication management for more than three months, (except for stable doses of antidepressants) and that could impact brain

function at the time of the study based on study MAI s discretion. Current or past tobacco use disorder or nicotine use, opioid use disorder in opioid use disorder participants, alcohol use disorder in alcohol use disorder participants, and both opioid and alcohol use disorders in the dual opioid and alcohol use disorder group is not exclusionary. Justification: The presence of severe or unstable comorbid psychiatric conditions could be associated with brain alterations that could confound the results. Assessment tool: history, MINI, clinical assessment, as well as review of medical records, including clinical exam, for experimental group.

6. Currently (at time of imaging sessions) using any medications that are known to alter BOLD signal such as stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil); anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; anticholinergics; anticonvulsants; antineoplastics; antiobesity; antipsychotics; hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; lithium; herbal products with

known psychotropic effects (e.g. Gingko biloba, or St. John s Wort) and other medications based on study MAI s discretion. Justification: Concomitant intake of medications that could alter BOLD signal could confound the results. Assessment tool: medical history for experimental groups; controls will also have a comprehensive urine toxicology screen.

7. Currently (at time of imaging sessions) taking methadone opioid replacement therapy. Please note that experimental group participants taking disulfiram, acamprosate, naltrexone, or long acting naltrexone treatment or those at a stable dose (for at least 2 weeks) of buprenorphine containing medications will be allowed to participate in the study. Justification: Opioid agonists or partial agonists are known to alter BOLD signal and could confound the results. However, about 60%-80% of opiate use disorder patients in PHP treatment programs receive buprenorphine. Excluding these participants could significantly decrease the chance for meeting our enrollment target. In addition, including these participants will result in better representation of the target population and enhance the generalizability of any findings. Assessment tool: medical history for experimental groups; controls will also have a comprehensive urine toxicology screen.

8. Medical conditions that can impact brain function such as seizure disorder, diabetes mellitus, renal insufficiency (e.g. Creatinine > 2.5), uncontrolled hypertension (BP> 160/100 on screening), uncontrolled or severe coronary artery disease, clinically significant heart disease, HIV, syphilis, or autoimmune disorders. Justification: The presence of medical conditions that can impact brain function will be associated with alterations in BOLD signal and could confound the results. Assessment tool: medical history and record re...


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427424


Contacts
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Contact: Elliot Stein, Ph.D. (443) 740-2650 estein@mail.nih.gov

Locations
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United States, Maryland
National Institute on Drug Abuse Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Elliot Stein, Ph.D.    443-740-2650    estein@mail.nih.gov   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Elliot Stein, Ph.D. National Institute on Drug Abuse (NIDA)

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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03427424     History of Changes
Other Study ID Numbers: 999918053
18-DA-N053
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 6, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Opioid use Disorder
Alcohol use Disorder
Physician Health Program
Functional Magnetic Resonance Imaging (fMRI)
Magnetic Resonance Spectroscopy
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Alcohol-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Analgesics, Opioid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents