A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery

NCT02173886 | Completed Phase 4

• 2 other identifiers: BUPEPSCOR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Roux en Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Bupropion Plasma Concentrations/Area-Under-the-Curve (AUC)

  The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of bupropion SR (sustained release) and bupropion XL (extended release) in Roux-en-Y Gastric Bypass and matched nonsurgical "control" subjects. Comparisons will be based upon bupropion plasma concentrations obtained during the 48 hour sample collection window.

  48 hours intervals

Secondary Outcomes (1)

• Secondary PK Characteristics

  48 hour collection

Study Arms (1)

Bupropion

EXPERIMENTAL

Bupropion SR and XL, single dosages of each separated by a wash-out period

Drug: Bupropion SR and XL

Interventions

Bupropion SR and XL DRUG

Bupropion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• North Dakota State University: lead
• Neuropsychiatric Research Institute, Fargo, North Dakota: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)