A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery

Completed · Phase 4

Conditions studied: Roux en Y Gastric Bypass

In brief

This study is being conducted to evaluate how the body absorbs and processes the sustained release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are 1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart.

Key facts

Study ID

NCT02173886

Run by

North Dakota State University

People needed

20

Starts

2014-06-01

Expected to finish

2015-02-01

Last updated by the study team

2016-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or Female
• Age 18-65 (inclusive, at time of informed consent)
• No tobacco use in the past three months.
• Underwent Roux-en-Y Gastric Bypass weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI.
• Ability to read, write and understand English

You may not qualify if…

• Taking a medication that has a clinically significant interaction with bupropion or an interaction that may alter the study data.
• Hypersensitivity to bupropion or any excipient contained within the dosage forms.
• Inability to tolerate repeated blood draws.
• Any history of bipoloar disorder or a psychotic disorder.
• Current major depressive disorder or current suicidality.
• Alcohol or substance dependence in the past year.
• Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
• Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
• Medical conditon which may increase participant risk with bupropion (e.g., history of significant head injury, seizure disorder, etc.)
• Self reported history of viral hepatits or HIV.
• Positive urine drug screen unless documented prescription of a non-interacting medication.
• History of seizures or epilepsy or other conditions which may increase seizure risk with bupropion as described in the package insert (e.g. history of significant head injury, alcoholism, etc).
• History of eating disorder such as anorexia nervosa or bulimia.
• Renal impairment as evidenced by an estimated glomerular filtration rate of less than 60 ml/min/1.73 m2 as reported by the laboratory, or any other abnormality on a renal panel that the medical provider feels puts the participant at risk or may compromise the study data
• Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
• Any significant electrolyte abnormality on a basic metabolic panel that the medical provider feels may put the subject at risk of a seizure from bupropion.

Where it is running

• Neuropsychiatric Research Institute — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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