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Imaging Biomarker for Addiction Treatment Outcome

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ClinicalTrials.gov Identifier: NCT03427424
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : July 4, 2022
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 21-65, 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 Show detailed description

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Imaging Biomarker for Addiction Treatment Outcome
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
AUD-E
Early-in-treatment, healthy alcohol use disorder participants currently enrolled in PHP within 2 months of starting treatment (AUD-E)
AUD-L
Long-term-in-treatment, healthy alcohol use disorder participants currently enrolled in PHP more than 2 months and less than 5 years (AUD-L)
Characterization
substance use disorder participants currently enrolled in PHP, not eligible for main imaging study
CON
healthy, non-drug using control participants (CON)
POAUD-E
Early-in-treatment, healthy dual prescription opioid and alcohol and use disorder participants currently enrolled in PHP within 2 months of starting treatment (POAUD-E)
POAUD-L
Long-term-in-treatment, healthy dual prescription opioid and alcohol use disorder participants currently enrolled in PHP 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 program (PHP) within 2 months of starting treatment (POUD-E)
POUD-L
Long-term-in-treatment, healthy prescription opioid use disorder participants currently enrolled in PHP more than 2 months and less than 5 years (POUD-L)



Primary Outcome Measures :
  1. 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 & 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.

  2. For the Addiction Phenotype Characterization arm: characterization measures [ Time Frame: at completion of characterization measures ]
    The outcome measures for the Addiction Phenotype Characterization arm are phenotypic factors that are related to addiction as measured by the psychiatric interview, drug use history assessments, and self-administered questionnaires to characterize clinical phenotype and physical condition.

  3. 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


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:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cross-sectional study will include participants enrolled in or affiliated with a PHP for more than 2 months. Longitudinal study will include participants who are enrolled in a PHP within about three 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
  • I. MAIN STUDY

A. INCLUSION CRITERIA:

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

  • Males and females between 21-65 years of age will be enrolled in the study.
  • Able and willing to provide written informed consent.
  • Must be right-handed.
  • Participants must be in good health.

Healthy control participants (CON) in addition to all participants inclusion criteria:

  • Free of lifetime DSM-5 substance use disorders except for tobacco use disorder.
  • 16 years of education or more

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

  • Recently (within about 3 months) enrolled in a physician health program (PHP) or equivalent at time of enrollment in the study.
  • Meet a minimum of 6/11 DSM-5 criteria for severe opioid use disorder (OUD) for about 2 years prior to enrollment and abstinent for about 1-3 months at time of imaging.

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

  • Recently (within about 3 months) enrolled in a physician health program (PHP) or equivalent at time of enrollment in the study.
  • Meet a minimum of 6/11 DSM-5 criteria for severe alcohol use disorder (AUD) for about 2 years prior to enrollment and abstinent for about 1-3 months at time of imaging.

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

  • Recently (within about 3 months) enrolled in a physician health program (PHP) or equivalent at time of enrollment in the study.
  • 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 for about 2 years for each substance prior to enrollment and abstinent for about 1-3 months at time of imaging.

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

  • Enrolled in or affiliated with a physician health program (PHP) or equivalent for more than 2 months at time of enrollment in the study.
  • Meet a minimum of 6/11 DSM-5 criteria for severe opioid use disorder for about 2 years prior to starting treatment and abstinent for at least 3 months at time of imaging.

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

  • Enrolled in or affiliated with a physician health program (PHP) or equivalent for more than 2 months at time of enrollment in the study and in full remission for at least 2 months at time of imaging.
  • Meet a minimum of 6/11 DSM-5 criteria for severe alcohol use disorder for about 2 years prior to starting treatment and abstinent for at least 3 months at time of imaging.

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

  • Enrolled in or affiliated with a physician health program (PHP) or equivalent for more than 2 months at time of enrollment in the study.
  • 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 about 2 years for each substance prior to enrollment and abstinent for at least 3 months at time of imaging.

EXCLUSION CRITERIA:

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

  • Females must not be pregnant or lactating.
  • 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.
  • Noise-induced hearing loss or tinnitus.
  • Head trauma with loss of consciousness for more than 30 minutes or significant sequelae for more than one month.
  • 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, or low dose (up to 100mg/day of Quetiapine or equivalent) of antipsychotics (experimental groups only) for at least one month prior to the time of a scanning visit) 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.
  • 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; 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.
  • 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.
  • 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), clinically significant heart disease, HIV, syphilis, or autoimmune disorders.
  • Clinically significant laboratory results (e.g. random glucose > 200 mg/dL, LFT (ALT, AST and GGT) > 3-fold upper limit of normal, or Hemoglobin < 10 gm/dL) or other clinically significant lab abnormalities based on study MAI s discretion.
  • Have any current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, or CNS tumor.
  • Are non-English speaking.
  • Suspected or confirmed acute SARS-CoV-2 infection.

II. ADDICTION PHENOTYPE CHARACTERIZATION

Note: Health professionals with prescription opioid, alcohol or dual prescription opioid and alcohol use disorder or other substances who are enrolled in or affiliated with a PHP and are not eligible for the main study (including for having an SUD that does not qualify for the main study) may be invited to participate in the Addiction Phenotype Characterization arm.

A. INCLUSION CRITERIA:

  • Males and females 21 years of age and older will be enrolled in the study.
  • Able and willing to provide informed consent.
  • Enrolled in or affiliated with a physician health program (PHP) or equivalent at the time of enrollment in the study.
  • Meet a minimum of 6/11 DSM-5 criteria for severe opiate, alcohol or both alcohol and opiate or other substance use disorder for at least 2 years prior to enrollment.

B. EXCLUSION CRITERION:

-Are non-English speaking.


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: Betty Jo Salmeron, M.D. (443) 740-2651 bsalmeron@intra.nida.nih.gov
Contact: Amy Janes, Ph.D. (443) 740-2650 amy.janes@nih.gov

Locations
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United States, Maryland
National Institute on Drug Abuse Recruiting
Baltimore, Maryland, United States, 21224
Contact: Betty Jo Salmeron, M.D.    443-740-2651    bsalmeron@intra.nida.nih.gov   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Amy Janes, Ph.D. National Institute on Drug Abuse (NIDA)
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03427424    
Other Study ID Numbers: 999918053
18-DA-N053
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: July 4, 2022
Last Verified: May 20, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .We plan to share IPD for this protocol; however, plans have not yet been finalized. We have not yet finalized decisions on types of supporting information that will be shared, IPD Sharing Time Frame, or IPD Sharing Access Criteria. As stated in the protocol, data will be stripped of identifiers prior to release for sharing. De-identified data may be shared with properly administered databases and/or with collaborators with whom proper data sharing agreements are in place (we will set-up proper data sharing agreements once a plan is determined).

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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
Natural History
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Alcohol-Related Disorders
Pathologic Processes
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders