Eligibility Details:
Inclusion Criteria for Cohort 1 and 2 (Healthy Volunteers):
1. Participants will be 18-60 years of age
2. "Healthy volunteer" is defined as being in good general health in the opinion of an
investigator (controlled diabetes, controlled hypertension or other well controlled
chronic medical conditions may be allowed at the discretion of an investigator if they
do not believe they will increase patient risk or interfere with the collection of
imaging data; specific excluded conditions are described under exclusion criteria)
3. Participants must be informed of the investigational nature of this study and provide
written informed consent in accordance with institutional and federal guidelines prior
to study-specific procedures.
Exclusion Criteria for Cohort 1 and 2 (Healthy Volunteers)
1. Females who are pregnant at the time of screening will not be eligible for this study,
urine pregnancy test will be performed in women of child-bearing potential at
screening.
2. History of contraindications to lorazepam (sensitivity to diazepines, sleep apnea
syndrome or severe respiratory insufficiency) as assessed by medical record review
and/or self-reported
3. History of significant gallbladder, kidney or liver disease as assessed by medical
record review and/or self-reported OR total bilirubin > 1.5 x ULN, ALT or AST > 3 x
ULN or creatinine clearance estimated to be less than 60 ml/min at screening. Subjects
with history of cholecystectomy will not be excluded.
4. History of epilepsy or seizure disorder as assessed by medical record review and/or
self-reported
5. History of head trauma, that in the opinion of an investigator may interfere with the
uptake of [18F]FTP as assessed by medical record review and/or self-reported
6. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or
psychotic disorder, or substance use disorders, as assessed by medical record review
and/or self-reported
7. Use of dopaminergic CNS stimulants (prescription, over-the counter or recreational
drugs) within 30 days of screening intake visit, as assessed by review of health
history form and concomitant medication review at screening intake visit (from medical
record and/or self-reported) that are deemed by a physician investigator to have a
potential influence on the binding of [18F]FTP
8. Positive urine drug screen at the screening intake visit
9. Self-reported current alcohol consumption that exceeds greater than 25 drinks per week
10. Any current medical condition, illness, or disorder as assessed by medical record
review and/or self-reported that is considered by a physician investigator to be a
condition that could compromise participant safety or successful participation in the
study
11. Participants with self-reported current nicotine dependence will be excluded.
Participants with self-reported history of nicotine use but who report no use within
at least 3 months prior to study enrollment will be eligible for the study if they
have a negative urine dipcard test for nicotine/cotinine at screening.
Inclusion criteria for Cohort 3 and 4 (cocaine-dependent)
1, Participants will be males 18-60 years of age 2. Cocaine-dependent (moderate to severe
cocaine use disorder, based on DSM-5 criteria), voluntarily seeking treatment for cocaine
dependence 3. Smoking is they self-reported primary route of cocaine administration 4. In
the past 30 days, no less than $100-worth of cocaine was used by self-report 5.
Participants must be informed of the investigational nature of this study and provide
written informed consent in accordance with institutional and federal guidelines prior to
study-specific procedures.
Exclusion criteria for Cohort 3 and 4 (cocaine-dependent)
1. Meets DSM-5 criteria for moderate to severe substance use disorder for any substance
other than cocaine, alcohol, marijuana or nicotine as determined by semi-structured
interview. Patients with comorbid alcohol use disorder will be accepted if their
alcohol use disorder is not severe enough to require a medicated alcohol
detoxification per standard UPHS policies
2. History of significant gallbladder, kidney or liver disease as assessed by medical
record review and/or self-reported OR total bilirubin > 1.5 x ULN, ALT or AST > 3 x
ULN or creatinine clearance estimated to be less than 60 ml/min at screening. Subjects
with history of cholecystectomy will not be excluded.
3. History of epilepsy or seizure disorder as assessed by medical record review and/or
self-reported
4. History of head trauma, that in the opinion of an investigator may interfere with the
uptake of [18F]FTP as assessed by medical record review and/or self-reported
5. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or
psychotic disorder as assessed by medical record review and/or self-reported. History
of unipolar depression or anxiety disorder may be accepted; current depression or
anxiety may be accepted if the severity does not require psychoactive medication.
6. Currently requires treatment with any psychoactive medications
7. Any current medical condition, psychiatric disorder, illness, or disorder as assessed
by medical record review and/or self-reported that is considered by a physician
investigator to be a condition that could compromise participant safety or successful
participation in the study
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
