Treatments
obesity
OBESITY
Treatment involved solely the double-blind medication (naltrexone/bupropion or placebo). There were no additional behavioral or psychotherapeutic interventions during this maintenance trial. Naltrexone/bupropion combination full dosing comprised naltrexone-sustained-release (32 mg/day) plus bupropion-sustained-release (360 mg/day) as in previous trials with obesity (Greenway et al., Our re-randomization pharmacotherapy protocol took both the acute and the maintenance pharmacotherapy assignments into consideration to maximize participant safety and reduce potential confounds attributable to unblinding. We provide the four re-randomization schedules in online Supplemental Material Text and Supplemental Figure. Briefly, participants switching from naltrexone/bupropion to placebo had a down-titration of naltrexone bupropion as part of their double-blind schedule, as well as up-titration of placebo. Participants switching from placebo to naltrexone/bupropion had an up-titration following procedures in previous trials with obesity (Greenway et al., At the first (initial) maintenance trial study visit, study physicians delivered the pharmacotherapy, which focused on medication management (compliance, safety, and side-effects). Additional psychotherapeutic or behavioral interventions were proscribed. Monthly medication refills were accompanied by re-reviewing medication compliance and dosing schedules; pill bottles were returned for pill counts at post-treatment. Side-effect and safety checklists were performed monthly by research clinicians.