Imaging Biomarker for Addiction Treatment Outcome

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    650
  • sponsor
    National Institute on Drug Abuse (NIDA)
Updated on 9 August 2022
opioid
medication treatment
antidepressant
substance use
opioid use
addiction
methadone
detoxification
amphetamine
psychoactive drugs
stimulant
narcotic use
modafinil
bipolar disorder
alcohol use disorder
opioid use disorder
drug dependence
head injury
smoke tobacco
toxicology screen
Accepts healthy volunteers

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.

Description

Objective

Despite recent advances in addiction neuroscience, achieving a breakthrough in predicting addiction treatment outcome has been difficult and long-term abstinence success unacceptably low. The aim of this study is to create a biomarker using various neuroimaging metrics that can predict treatment outcome in opioid, alcohol and dual opioid and alcohol use disorder patients.

Study Population:

Total study enrollment will include up to 650 participants. The main study population will include up to five hundred (500) participants to reach three hundred fifty (350) completers (50 per group) based on their addiction status (1) healthy, non-drug using control participants (CON) (2) Early-in-treatment, healthy prescription opioid use disorder participants currently enrolled in physician health program (PHP) within 3 months of starting treatment (POUD-E), (3) Long-term-in-treatment, healthy prescription opioid use disorder participants currently enrolled in or affiliated with a PHP more than 2 months (POUD-L), (4) Early-in-treatment, healthy alcohol use disorder participants currently enrolled in PHP within 3 months of starting treatment (AUD-E), (5) Long-term-in-treatment, healthy alcohol use disorder participants currently enrolled in or affiliated with a PHP more than 2 months (AUD-L), (6) Early-in-treatment, healthy dual prescription opioid and alcohol and use disorder participants currently enrolled in PHP within 3 months of starting treatment (POAUD-E), (7) Long-term-in-treatment, healthy dual prescription opioid and alcohol use disorder participants currently enrolled in or affiliated with a PHP more than 2 months (POAUD-L). The Addiction Phenotype Characterization arm will include up to 150 completers.

Design

The main study includes two studies that will run simultaneously:

Cross-sectional study that will include participants who have been in treatment for more than 2 months and are either enrolled at a PHP if within the required monitoring period of 5 years or still affiliated with their PHP after successfully completing their 5-year monitoring period. Three target groups, in addition to the control group, will be included in this study [POUD-L, AUD-L, and POAUD-L]. Each participant will complete a screening evaluation session (approximately 3-4 hours) and a second session for study consent review (approximately 1-2 hours) at home or at the PHP through secure communication. These sessions will include the screening consent process, administration of a structured psychiatric interview and a semi-structured assessment, instructions for the completion of detailed self-administered questionnaires to characterize clinical phenotype and physical condition, and consent review for the study. Participants subsequently cleared for and enrolled in the cross-sectional study will be invited to come to NIDA IRP for one imaging visit that will take approximately 8-10 hours.

The aim of the cross-sectional study is to identify imaging based brain differences between control group and drug using groups and to examine correlations between brain imaging markers at different stages of recovery and (1) severity of drug use (duration and quantity), (2) duration of abstinence, and (3) number of relapses in drug using groups.

The primary outcome measure for the 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.

Longitudinal study that will include participants who are enrolled at a PHP within about three months of starting treatment. Three groups, in addition to the control group, will be included in this study [POUD-E, AUD-E, and POAUD-E]. Each participant will complete the screening sessions as described in the cross-sectional study. Eligible participants will undergo three imaging visits at NIDA; 1) 1st (baseline) visit within about 2 months of eligibility determination, (2) 2nd (mid-year) visit within 4-8 months of baseline visit and (3) 3rd (one-year) visit within 10-14 months of baseline visit. Each imaging visit will take approximately 8-10 hours.

The aim of the longitudinal study is to measure brain imaging changes over time in abstinent and relapsing addicts and to identify brain imaging markers that differentiate between abstinent and relapsing participants at 6 months and at 1 year. The rationale behind the mid-year visit is that most relapses take place early (within the first 6 months) during treatment and, by one year, some of those who relapsed earlier achieve abstinence. We chose one year follow up in order to compare brain imaging changes between abstinent and relapsing participants after relatively long sobriety and to add clinical value to our prediction model. By including both of these visits, we will obtain three scans on both abstinent without early relapse and abstinent with early relapse in order to uncover salient brain differences between those who relapse early and those who maintain abstinence.

The primary outcome measure for the longitudinal study will be differences in baseline and changes over time in functional connectivity circuits and 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. Most importantly, we will use imaging, behavioral and genetic measures at the onset of treatment in a machine-learning framework in an attempt to predict subsequent treatment success in this cohort of participants.

Secondary outcome measures for both studies will be phenotypic (performance on behavioral tasks, self-reported measures of cravings, impulsivity and personality traits), genotypic and imaging (structural, functional and spectroscopy) differences between different addiction groups.

The Addiction Phenotype Characterization arm will include participants who are ineligible for the main study due to imaging-related exclusions or other medical exclusions (e.g. medications, other SUD disorders). These participants will complete the characterization measures (structured psychiatric interview, a semi-structured drug use history assessment, and several self-administered questionnaires to characterize clinical phenotype and physical condition).

The aim of the Addiction Phenotype Characterization arm is to characterize addiction phenotype and physical condition in health professionals.

The primary outcome measures for the Addiction Phenotype Characterization arm are the characterization measures.

Details
Condition Opioid-Related Disorders, Alcohol-Related Disorders
Clinical Study IdentifierNCT03427424
SponsorNational Institute on Drug Abuse (NIDA)
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

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

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
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
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>
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
Current or past DSM-5 diagnosis of any psychiatric disorder that required
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
Currently (at time of imaging sessions) using any medications that are known to alter
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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