Imaging Biomarker for Addiction Treatment Outcome

NCT03427424 | Terminated

• 2 other identifiers: 99991805318-DA-N053
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders; Alcohol-Related Disorders

Keywords

Opioid use Disorder; Alcohol Use Disorder; Physician Health Program; Functional Magnetic Resonance Imaging (fMRI); Magnetic Resonance Spectroscopy; Natural History

Outcome Measures

Primary Outcomes (3)

• 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...

  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.

  6 & 12 mo f/u visits

• For the Addiction Phenotype Characterization arm: 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.

  at completion of characterization measures

• 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

  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

  1 study visit

Secondary Outcomes (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.

  At each visit

Study Arms (8)

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)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Males and females 21 years of age and older will be enrolled in the study.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Alcohol-Related Disorders; Alcoholism

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amy Janes, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 9, 2018
• Study Start: July 10, 2019
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (1)