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Trial record 98 of 382 for:    under | North Dakota, United States

A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02173886
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : September 28, 2016
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
Kristine Steffen, North Dakota State University

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.

Condition or disease Intervention/treatment Phase
Roux en Y Gastric Bypass Drug: Bupropion SR and XL Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Bupropion Plasma Concentrations/Area-Under-the-Curve (AUC) [ Time Frame: 48 hours intervals ]
    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.

Secondary Outcome Measures :
  1. Secondary PK Characteristics [ Time Frame: 48 hour collection ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02173886

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United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
North Dakota State University
Neuropsychiatric Research Institute, Fargo, North Dakota

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Responsible Party: Kristine Steffen, Associate Professor, North Dakota State University Identifier: NCT02173886     History of Changes
Other Study ID Numbers: BUP
EPSCOR ( Other Identifier: North Dakota State University )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors