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Recruiting

NCT Number: NCT03460314

Bariatric Surgery and Pharmacokinetics of Buprenorphine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on buprenorphine are investigated.

Recruiting

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Olavs University Hospital

Trondheim, Norway

Location status: Recruiting

Location contact

Magnus Strømmen, MSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
  • Being a Norwegian citizen

Exclusion criteria

  • Having previously undergone resections in the GI-tract

Treatment and study plan

buprenorphine

Drug

Patients are tested for their normal prescription buprenorphine medication

Other names: Buprenorphine hydrochloride, Buprenex

Primary outcomes

  1. Buprenorphine concentration in blood serum (area under curve (AUC))

    Time frame: From baseline to 1 year postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus Strømmen, MSc

CONTACT

[email protected]

0047 72829970

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • Namsos Hospital
  • St. Olavs Hospital
  • Volvat Medisinsk Senter Stokkan

Registry information

Official study title

Bariatric Surgery and Pharmacokinetics Buprenorphine: BAR-MEDS Buprenorphine

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2018
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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