Varenicline for the Treatment of Smokeless Tobacco

NCT00813917 | Completed Results

• 2 other identifiers: 08-005359CA132621-01A1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• 7-day Point Prevalence All Tobacco Abstinence

  7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml

  12 weeks - end of treatment

Study Arms (2)

varenicline

ACTIVE COMPARATOR

Drug: varenicline

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

varenicline DRUG

12 weeks of varenicline 1 mg by mouth twice per day

Also known as: Chantix

varenicline

placebo DRUG

12 weeks of placebo (double blinded) by mouth twice per day

Also known as: Chantix placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible to participate if they:
• Are at least 18 years of age
• Have used ST daily for the past 12 months (regular user)
• Identify ST as their primary tobacco product
• Are in general good health (determined by medical history and screening physical examination)
• Has provided written informed consent to participate
• Are able to participate in all aspects of the study

You may not qualify if:

• Individuals will be excluded from study participation if they:
• Are currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation programs (i.e., behavioral therapy, nicotine replacement therapy, clonidine, bupropion SR, or doxepin)
• Have self-reported current, untreated depression or a Beck Depression Inventory (BDI-II) Score of ≥ 20
• Have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale);current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.")
• History of psychosis or bipolar disorder
• Are currently pregnant or lactating or is of childbearing potential and not willing to use any form of contraception
• Have another member of their household already participating in this study
• Are allergic to varenicline
• Describe having a medical history of:
• Unstable angina
• Myocardial infarction within the past 3 months
• Cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT
• Medically-treated or untreated hypertension with BP ≥ 200 systolic OR ≥ 100 diastolic
• Have other medical or psychiatric conditions that would exclude the participant

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Nicotine Research Program

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Ebbert JO, Croghan IT, Severson HH, Schroeder DR, Hays JT. A pilot study of the efficacy of varenicline for the treatment of smokeless tobacco users in Midwestern United States. Nicotine Tob Res. 2011 Sep;13(9):820-6. doi: 10.1093/ntr/ntr078. Epub 2011 Apr 18.

  PMID: 21504885 RESULT

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Jon O. Ebbert, MD
• Organization: Mayo Clinic

nicotineresearch@mayo.edu

507-266-1944

Study Officials

• Jon O. Ebbert, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 16, 2012
• Results First Posted: September 9, 2011

Record last verified: 2012-07

Locations

US (1)