Varenicline for Light Smokers

NCT01639560 | Completed Phase 4 Results DMC

• 2 other identifiers: 12-005652WS2293926
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if varenicline is effective in treating tobacco dependence in adults who smoke 5-10 cigarettes per day.

Conditions

Smoking

Keywords

smoking; tobacco dependence; nicotine dependence

Outcome Measures

Primary Outcomes (2)

• Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)

  To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.

  12 weeks

• Prolonged Smoking Outcome at 12 Weeks (End of Treatment)

  To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.

  12 weeks

Secondary Outcomes (2)

• Point Prevalence Smoking Outcome at 24 Weeks (End of Study)

  24 weeks

• Prolonged Smoking Outcome at 24 Weeks (End of Study)

  24 weeks

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

1 mg of varenicline twice per day for 12 weeks.

Drug: Varenicline

placebo

PLACEBO COMPARATOR

1 placebo tablet twice a day for 12 weeks

Drug: Placebo

Interventions

Varenicline DRUG

1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling

Also known as: chantix

Varenicline

Placebo DRUG

1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Also known as: sugar pill

placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must be ≥ 18 years of age;
• smokes 5 to 10 CPD for at least 6 months;
• express interest in quitting smoking;
• indicate ability to complete all study visits; and
• provide written informed consent to participate in the study.
• Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
• Subject is in good health as determined by the investigator;
• Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments.

You may not qualify if:

• An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;
• History of renal failure;
• Cancer \[excluding non-melanoma skin cancer\] not in remission;
• Psychosis or bipolar disorder;
• Current unstable or untreated moderate or severe depression as assessed by the CES-D;
• 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.");
• Substance dependence other than nicotine, defined as:
• a. Patient has a recent history (past month) of heavy alcohol consumption as defined by NIAAA: i. Men: More than 4 drinks on any day or 14 per week ii. Women: More than 3 drinks on any day or 7 per week. b. Use of cocaine, heroin, club drugs (i.e., MDMA/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past month.
• c. Use of marijuana on a weekly basis for the past month
• An allergy to varenicline;
• Current use of a behavioral or pharmacologic tobacco dependence treatment and unwilling or unable to discontinue use;
• Another member of their household already participating in this study; and
• Current treatment with another investigational drug (within 30 days of study entry).
• Has an unstable medical condition;
• Subject has untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100;

Sponsors & Collaborators

• Mayo Clinic: lead
• Pfizer: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Ebbert JO, Croghan IT, Hurt RT, Schroeder DR, Hays JT. Varenicline for Smoking Cessation in Light Smokers. Nicotine Tob Res. 2016 Oct;18(10):2031-5. doi: 10.1093/ntr/ntw123. Epub 2016 Apr 26.

  PMID: 27117285 RESULT

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder

Interventions

Varenicline; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

nicotineresearch@mayo.edu

507-266-1944

Study Officials

• Jon O. Ebbert, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Ivana T. Croghan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 22, 2018
• Results First Posted: October 13, 2016

Record last verified: 2018-01

Locations

US (1)