A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery

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.

Study Overview

• Status: Completed
• Conditions: Roux en Y Gastric Bypass
• Intervention / Treatment: Drug: Bupropion SR and XL

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Neuropsychiatric Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female
2. Age 18-65 (inclusive, at time of informed consent)
3. No tobacco use in the past three months.
4. 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.
5. Ability to read, write and understand English

Exclusion Criteria:

1. Taking a medication that has a clinically significant interaction with bupropion or an interaction that may alter the study data.
2. Hypersensitivity to bupropion or any excipient contained within the dosage forms.
3. Inability to tolerate repeated blood draws.
4. Any history of bipoloar disorder or a psychotic disorder.
5. Current major depressive disorder or current suicidality.
6. Alcohol or substance dependence in the past year.
7. Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
8. 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).
9. Medical conditon which may increase participant risk with bupropion (e.g., history of significant head injury, seizure disorder, etc.)
10. Self reported history of viral hepatits or HIV.
11. Positive urine drug screen unless documented prescription of a non-interacting medication.
12. 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).
13. History of eating disorder such as anorexia nervosa or bulimia.
14. 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
15. 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.
16. 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupropion; Bupropion SR and XL, single dosages of each separated by a wash-out period	Drug: Bupropion SR and XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary PK Characteristics	We will also evaluate other PK characteristics associated with bupropion, such as Cmax, Tmax, t1/2, and the ratio of bupropion to the active metabolite ODV, and others.	48 hour collection

Collaborators and Investigators

• Sponsor: North Dakota State University
• Collaborators: Neuropsychiatric Research Institute, Fargo, North Dakota

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: BUP; EPSCOR (Other Identifier: North Dakota State University)