SMART Use of Medication for the Treatment of Adolescent Severe Obesity

Prior treatment

• Current or recent (\<6 months prior to enrollment) use of weight loss medication(s);
• Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
• Previous bariatric surgery;
• Recent initiation of change in dose (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
• Suicidal ideation or self-harm within 12 months prior to enrollment;

Other illness

• Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (\< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
• Diabetes (type 1 or 2);
• Presence of cardiac pacemaker;
• Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
• Seizure disorder (other than infantile febrile seizure);
• History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
• Any history of suicide attempt;
• History of cholelithiasis;
• History of nephrolithiasis;
• Untreated thyroid disorder;

Lab values

• Bicarbonate \< 18 mmol/L;
• Creatinine \> 1.2 mg/dL;

Other

• Tobacco use
• Unstable depression or anxiety that has required hospitalization in the past year;
• Hyperthyroidism;
• Breastfeeding

• Provision of signed and dated informed assent form;
• Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• BMI \>/= 1.2 times the 95th percentile or BMI \>/= 35 Kg/m2, whichever is lower;
• Tanner stage \>/= 2;
• Male or female, aged 12-17 at time of consenting;
• For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.