Intranasal Oxytocin and Food Intake in Obese Adolescents

Participants will undergo a telephone screening and then, within 4 weeks, complete an
in-person screening visit to determine eligibility. Then, within 4 weeks they will be
randomized to either OXT or placebo. After a minimum 1-week (7-28 days) "washout,"
participants will cross-over to treatment with the other condition (i.e., placebo or OXT).

Inclusion Criteria:

1. Proficient in English.

2. Pubertal or Post-Pubertal Females: 13 to <18 years.

3. Pubertal or Post-Pubertal Males: 15 to <20 years.

4. Girls must have a negative urine pregnancy test and post-menarchal girls must use an
acceptable method of contraception, including abstinence, a barrier method (diaphragm
or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.

5. Currently obese (BMI >95%ile for age/sex if age < 18 years, BMI > 30 kg/m2 age 18 - 20
years). In children, obesity is defined with respect to age- and sex based as greater
than or equal to the 95th%ile1, whereas in adults, an absolute threshold is used.

6. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Diabetes mellitus requiring insulin or insulin secretagogue. (Laboratory values:
HgbA1c ≥8.5%)

2. Cardiovascular condition, as defined as any of the following: i) abnormal blood
pressure, defined as <3%ile or >97%ile for age, sex and height 3, for adult
participants abnormal blood pressure is defined as Stage 2 hypertension (systolic BP >
160 mm Hg or diastolic BP > 100 mm Hg); ii) history of cardiac arrhythmia or
arrhythmia detected on screening ECG; iii) history of heart failure and/or
cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome
phenotype and/or positive genotype for long QT syndrome pathogenic mutations.

3. Concurrent use of medications known to prolong QTc interval and pose high risk for
Torsades de Pointes (TdP) according to the current information available
(www.crediblemeds.org). Concomitant medications will be assessed by the
Investigational Drug Service (IDS) pharmacist, in collaboration with the study
cardiologist, if additional clarification is needed. In addition, we require that
potential participants be on a stable dose for at least 2 months of any medication
with the potential to alter cardiac rhythm to ensure the screening ECG reflects
steady-state physiology.

4. Laboratory abnormalities that indicate abnormal sodium level, liver or renal disease,
or anemia:

Sodium - Outside Normal Range; Aspartate Aminotransferase (AST)/SGOT > 3.0 X's Upper
Limit of Normal (ULN); Alanine Aminotransferase (ALT)/SGPT > 3.0 X's Upper Limit of
Normal (ULN); Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2;
Hemoglobin < 10 g/dL

5. Seizure in the past 12 mos.

6. History of gastrectomy, gastric bypass, small or large bowel resection.

7. History of active substance abuse.

8. Current use of psychiatric medications. Current psychotic disorder and/or suicidality.

9. Other chronic medical conditions or medications likely to affect appetite or food
intake.

10. Any investigational drug use within 30 days prior to enrollment.

11. Pregnant or lactating females.

12. Inability to take intranasal medication (e.g., recent injury)

13. Parents/guardians or subjects who, in the opinion of the Investigator, may be
non-compliant with study schedules or procedures.