Imaging Biomarker for Addiction Treatment Outcome

Stopped early

Conditions studied: Opioid-Related Disorders, Alcohol-Related Disorders

In brief

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.

Key facts

Study ID: NCT03427424
Run by: National Institute on Drug Abuse (NIDA)
People needed: 52
Starts: 2019-07-10
Expected to finish: 2024-04-29
Last updated by the study team: 2024-05-01

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
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.

Where it is running

National Institute on Drug Abuse — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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