Varenicline for Light Smokers

NCT ID: NCT01639560

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-06-30

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.

Detailed Description

Nearly 50% of U.S. cigarette smokers smoke ≤ 10 cigarettes per day (CPD) and are considered "light smokers." Most light smokers will either maintain a chronic light smoking habit or increase their level of smoking during their lifetime. Importantly, light smokers are at risk for adverse health consequences and increased all-cause mortality. While multiple factors such as reinforcement behavior, diminished autonomy, economic constraints and tobacco control policies influence light smoking, nicotine dependence appears particularly important in 5 to 10 CPD smokers. Despite the high prevalence of light smoking and its increased healthcare burden, few studies have evaluated the efficacy of pharmacotherapy for this group of smokers. Varenicline, which targets symptoms of nicotine dependence, has been shown to increase smoking abstinence rates in moderate to heavy smokers (≥ 10 cigarettes per day). However, varenicline has not been evaluated in subjects who smoke < 10 CPD. In the current proposal we will investigate the efficacy of varenicline for smoking cessation in 5 to 10 CPD light smokers who wish to quit. This study will be conducted as a double-blind, placebo-controlled, randomized clinical trial at the Mayo Clinic, enrolling 224 eligible participants who smoke 5 to 10 CPD. Participants will receive behavior therapy and either varenicline or placebo for 12 weeks with follow up through 26 weeks. We will determine if varenicline increases smoking abstinence in light smokers at end-of-treatment and 26 weeks as compared to placebo.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Varenicline

1 mg of varenicline twice per day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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

placebo

1 placebo tablet twice a day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Varenicline

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

chantix; sugar pill

Eligibility Criteria

Inclusion Criteria

1. Subjects must be ≥ 18 years of age;

2. smokes 5 to 10 CPD for at least 6 months;

3. express interest in quitting smoking;

4. indicate ability to complete all study visits; and

5. provide written informed consent to participate in the study.

6. 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;

7. Subject is in good health as determined by the investigator;

8. Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments.

Exclusion Criteria

1. An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;

2. History of renal failure;

3. Cancer [excluding non-melanoma skin cancer] not in remission;

4. Psychosis or bipolar disorder;

5. Current unstable or untreated moderate or severe depression as assessed by the CES-D;

6. 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.");

7. 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

8. An allergy to varenicline;

9. Current use of a behavioral or pharmacologic tobacco dependence treatment and unwilling or unable to discontinue use;

10. Another member of their household already participating in this study; and

11. Current treatment with another investigational drug (within 30 days of study entry).

12. Has an unstable medical condition;

13. Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;

14. Women of child-bearing potential, or who are pregnant, lactating or likely to become pregnant during the trial and are unwilling to use an acceptable form of contraception during the medication phase will also be excluded. All female subjects of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jon Ebbert

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon O. Ebbert, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Ivana T. Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27117285 (View on PubMed)

Other Identifiers

WS2293926

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12-005652

Identifier Type: -

Identifier Source: org_study_id