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Status:

TERMINATED

Imaging Biomarker for Addiction Treatment Outcome

Lead Sponsor:

National Institute on Drug Abuse (NIDA)

Conditions:

Opioid-Related Disorders

Alcohol-Related Disorders

Eligibility:

All Genders

21-65 years

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 ...

Detailed 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. ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    July 10 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    April 29 2024

    Estimated Enrollment :

    52 Patients enrolled

    Trial Details

    Trial ID

    NCT03427424

    Start Date

    July 10 2019

    End Date

    April 29 2024

    Last Update

    May 1 2024

    Active Locations (1)

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    1

    National Institute on Drug Abuse

    Baltimore, Maryland, United States, 21224