Venlafaxine PK Following Bariatric Surgery (VLX)

April 4, 2016 updated by: Kristine Steffen, North Dakota State University

A Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery

This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy 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. This study will enroll up to 30 participants.

Study Overview

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 or Sleeve Gastrectomy 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. Criteria for matching will be established at the beginning of the study in consultation with the statistical team and addressed as needed with the input of the biostatistician.
  5. Ability to read, write and understand English

Exclusion Criteria:

  1. Taking a medication that has a clinically significant interaction with venlafaxine or an interaction that may alter the study data.
  2. Hypersensitivity to venlafaxine 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 venlafaxine or uncontrolled hypertension at the discretion of the examining provider.
  10. 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.
  11. Renal impairment as evidence by a calculated creatinine clearance of less than or equal to 70ml/min or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
  12. Poor or ultra-rapid Cytochrome P450 2D6 metabolizer.
  13. Self reported history of viral hepatits or HIV.
  14. Positive urine drug screen unless documented prescription of a non-interacting medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: venlafaxine
Venlafaxine IR and XR, single dosages of each separated by a wash-out period
Other Names:
  • Effexor and Effexor XR
Other: Venlafaxine XR and Venlafaxine IR
Each participant (3 groups of participants) will receive one dose of venlafaxine IR and one dose of venlafaxine XR seperated by a wash-out period.
Other Names:
  • Effexor and Effexor XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC)
Time Frame: 24 hours intervals
The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window.
24 hours intervals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary PK Characteristics (Composite)
Time Frame: 24 hour collection
We will also evaluate other PK characteristics associated with venlafaxine, such as Cmax, Tmax, t1/2, and the ratio of venlafaxine to the active metabolite ODV, and others.
24 hour collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kristine J Steffen, Pharm.D., Ph.D., North Dakota State University & Neuropsychiatric Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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