Contrave and Remote Behavioral Weight Loss Intervention for the Improvement of Weight Loss in Women with Stage I-III Breast Cancer

Inclusion Criteria

• At least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy * NOTE: Concurrent endocrine therapy or anti-HER2 therapy is permitted. Concurrent enrollment in other interventional or drug clinical trials is at the discretion of the protocol chair
• Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast
• Up to date with recommended screening mammography within one year * NOTE: Women who have had a mastectomy (including simple mastectomy, modified radical mastectomy, and radical mastectomy) to treat breast cancer need no further routine screening mammograms on the affected side. If both breasts are removed (a double or bilateral mastectomy), they don't need mammograms at all * NOTE: Women who have had breast-conserving surgery (e.g., partial mastectomy or lumpectomy) should have a mammogram of the treated breast 6 to 12 months after radiation treatment ends. After that, women should have annual mammograms
• Current body mass index (BMI) >= 30 kg/m^2 or BMI 27.0-29.9 kg/m^2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight =< 400 lbs * NOTE: Participants should not have weight loss greater than 5% of body weight in the last 6 months. All weights for determination of eligibility may be determined by self-report of weight if not documented in the medical records. During the study, if any surgical procedures are required, the difference between weight prior to surgery and after surgery will be accounted for and require notification of the protocol chair/designee
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Willingness to change diet, physical activity, track behaviors, engage in weekly and monthly contacts and visit, and take chronic weight loss medication
• Able to read and write the English language without assistance and daily access to the email and/or smartphone * NOTE: Participants who are unable to receive email or to complete the online questionnaires for any reason will not be eligible for the study
• Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

Exclusion Criteria

• Serious/uncontrolled medical condition at the discretion of the protocol chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
• Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
• Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication
• Diabetes on insulin or sulfonylureas within the past 3 months
• Unstable psychiatric disorder or bulimia/anorexia nervosa
• Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug
• Use of the following medications are excluded: * Tamoxifen * Monoamine oxidase (MAO) inhibitors (must be > 14 days from discontinuation) * Thyroid medication use unless on stable doses for at least the past 3 months * Bupropion containing products or opiate agonists (must be > 14 days from discontinuation) * Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat, Qsymia, Contrave) within the past 3 months * Medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months. NOTE: An exception to this is that selective serotonin reuptake inhibitors (SSRI’s) and serotonin norepinephrine reuptake inhibitors (SNRI’s) are allowed if participant has been on stable doses for at least 3 months (if discontinued, a washout of 2 weeks from prior SSRI/SNRI use is required) * Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, angiotensin-converting enzyme [ACE] inhibitors, beta blockers and statins) unless on stable doses >= 3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required). Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) are allowed if use is limited to < 3 times per week; chronic NSAIDs are permitted on study only if use has been >= 3 times per week for at least 3 months prior to registration and is expected to continue ** NOTE: No medication should be discontinued without guidance of the prescribing provider