Snus and Home Blood Pressure

NCT06019910 | Recruiting

• 1 other identifier: snus2023
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake. 28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation, as well as after snus relapse if such a relapse occurs.

Conditions

Blood Pressure; Dyslipidemias; Dysglycemia; Obesity

Outcome Measures

Primary Outcomes (2)

• Home blood pressure during snus cessation

  Change in home blood pressure from baseline until week 4 and week 12 respectively

  4-12 weeks

• Home blood pressure during snus relapse

  Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively

  4-12 weeks

Secondary Outcomes (10)

• Body weight during snus cessation

  4-12 weeks

• Concentration of plasma lipids during snus cessation

  4-12 weeks

• Concentration of fasting plasma glucose during snus cessation

  4-12 weeks

• Concentration of fasting plasma insulin during snus cessation

  4-12 weeks

• Concentration of blood HbA1c during snus cessation

  4-12 weeks

Study Arms (1)

Snus with or without tobacco

EXPERIMENTAL

Snus cessation followed by potential snus relapse

Other: Snus with or without tobacco

Interventions

Snus with or without tobacco OTHER

At baseline, participants have used the intervention daily for at least 30 days. They will then cease usage of the intervention abruptly. After 3 weeks, they may continue to abstain from the intervention or relapse at their own discretion.

Snus with or without tobacco

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• daily use (defined as at least once daily for at least 1 month) o snus
• the ability to use online questionnaires written and answered in Swedish

You may not qualify if:

• simultaneous use of any other nicotine or tobacco product (including cigarette smoking, e-cigarettes, and nicotine replacement therapy)
• drug use (including cannabis)
• alcohol dependence
• known cardiovascular disease (including hypertension, previous myocardial infarction, stroke, peripheral arterial disease, or angina pectoris), kidney disease, hormonal disease (including diabetes mellitus) or eating disorder
• current or planned pregnancy.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Primary Health Care Center Cityhälsan Centrum

Norrköping, Sweden

RECRUITING

Related Publications (8)

• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.

  PMID: 30234752 BACKGROUND

• Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.

  PMID: 29630702 BACKGROUND

• Middlekauff HR, Park J, Moheimani RS. Adverse effects of cigarette and noncigarette smoke exposure on the autonomic nervous system: mechanisms and implications for cardiovascular risk. J Am Coll Cardiol. 2014 Oct 21;64(16):1740-50. doi: 10.1016/j.jacc.2014.06.1201.

  PMID: 25323263 BACKGROUND

• Martinez-Morata I, Sanchez TR, Shimbo D, Navas-Acien A. Electronic Cigarette Use and Blood Pressure Endpoints: a Systematic Review. Curr Hypertens Rep. 2020 Nov 23;23(1):2. doi: 10.1007/s11906-020-01119-0.

  PMID: 33230755 BACKGROUND

• Audrain-McGovern J, Benowitz NL. Cigarette smoking, nicotine, and body weight. Clin Pharmacol Ther. 2011 Jul;90(1):164-8. doi: 10.1038/clpt.2011.105. Epub 2011 Jun 1. No abstract available.

  PMID: 21633341 BACKGROUND

• Chiolero A, Faeh D, Paccaud F, Cornuz J. Consequences of smoking for body weight, body fat distribution, and insulin resistance. Am J Clin Nutr. 2008 Apr;87(4):801-9. doi: 10.1093/ajcn/87.4.801.

  PMID: 18400700 BACKGROUND

• Hofstetter A, Schutz Y, Jequier E, Wahren J. Increased 24-hour energy expenditure in cigarette smokers. N Engl J Med. 1986 Jan 9;314(2):79-82. doi: 10.1056/NEJM198601093140204.

  PMID: 3941694 BACKGROUND

• Af Geijerstam P, Joelsson A, Radholm K, Nystrom FH. Cardiovascular and metabolic changes following 12 weeks of tobacco and nicotine pouch cessation: a Swedish cohort study. Harm Reduct J. 2025 Apr 16;22(1):54. doi: 10.1186/s12954-025-01195-y.

  PMID: 40241094 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Obesity

Interventions

Tobacco, Smokeless; Tobacco Products

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Fredrik H Nyström, PhD, MD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peder af Geijerstam, MD

CONTACT

+460739597426; peder.af.geijerstam@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of internal medicine and endocrinology

Model Details: At baseline, all participants use snus, and will be asked to quit their usage. They will then be followed for up to 12 weeks. If and when they relapse in snus use, another 12 weeks will commence, during which the same measurements will repeated but for a second period of up to 12 weeks.

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 31, 2023
• Study Start: October 9, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

SE (1)