Eligibility |
- 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.
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