Bariatric Surgery and Pharmacokinetics of Buprenorphine

NCT ID: NCT03460314

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-02

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Buprenorphine

Patients are tested for their normal prescription buprenorphine medication

Intervention Type DRUG

Other Intervention Names

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Buprenorphine hydrochloride Buprenex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Volvat Medisinsk Senter Stokkan

OTHER

Sponsor Role collaborator

Namsos Hospital

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Strømmen, MSc

Role: PRINCIPAL_INVESTIGATOR

St. Olavs University Hospital

Locations

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St. Olavs University Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Magnus Strømmen, MSc

Role: CONTACT

0047 72829970

Facility Contacts

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Magnus Strømmen, MSc

Role: primary

Other Identifiers

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2016/1145g

Identifier Type: -

Identifier Source: org_study_id

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