Varenicline for Light Smokers

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT01639560

Run by

Mayo Clinic

People needed

93

Starts

2013-01-01

Expected to finish

2016-06-01

Last updated by the study team

2018-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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;
• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.