Varenicline for Smoking Reduction and Abstinence in Light and Intermittent Smokers
This trial studies how varenicline affects the ability to reduce smoking and quit smoking in light and intermittent smokers. Many light and intermittent smokers do not experience nicotine withdrawal. Instead, they mostly smoke in response to smoking triggers (environmental, social, or physical). Varenicline may affect how smokers feel the need to smoke in response to common triggers.
Inclusion Criteria
- Daily smoker using 10 or less cigarettes per day but a minimum of at least 1 cigarette per week or 4 cigarettes (cigs)/month
- Willing to quit smoking in the next 30 days
- Is able to provide written informed consent (in English) to participate in the study and is able to read/understand the procedures and study requirements
- Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure
- If female and of childbearing potential, is willing to use medically acceptable contraceptive measures for the duration of the study. Acceptable methods of contraception include (1) surgical sterilization (such as tubal ligation or hysterectomy, (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as rhythm method or Plan B, sold for emergency use after unprotected sex, are not acceptable methods for routine use
- Have access to a cell phone that can send and receive short message service (SMS) text messages
Exclusion Criteria
- Use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion) in last 7 days
- Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) in the last 7 days
- Score of 10 or greater on Patient Health Questionnaire (PHQ-9) Depression Scale
- Answer > 0 on suicidality question (Questions 9) of Patient Health Questionnaire (PHQ-9) Depression Scale
- Score of 15 or greater on the General Anxiety Disorder 7-item (GAD-7) Scale
- Active alcohol use disorder or hazardous drinking. This will be initially screened on the phone with the Alcohol Use Disorders Identification Test (AUDIT)-C, and a score 5 or greater is exclusionary for both men and women. Positive scores of 3 or 4 will result in study clinician assessment and discretion. At the in person-screening visit, the AUDIT will be administered with scores of 8 or greater exclusionary
- Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, and/or methamphetamine)
- Severe symptomatic depression and or anxiety (study medical provider discretion)
- Diagnosis of bipolar disorder, schizophrenia, post-traumatic stress disorder (PTSD) and or adult attention deficit hyperactivity disorder (ADHD) (study medical provider discretion)
- Chronic medical illness including diabetes with the use of insulin, hemoglobin A1c > 7 (study medical provider discretion), heart disease diagnosed by angiogram, or chronic obstructive pulmonary disease (COPD) diagnosed by pulmonary function testing and requiring an oxygen supply
- Specific medications
- Abnormal finding on physical exam (study medical provider discretion)
- Positive urine pregnancy test (women of child bearing potential only; QuickVue urine pregnancy)
- Positive urine toxicology-5 screen (methamphetamine, cocaine, opiates, benzodiazepines, delta-9-tetrahydrocannabinol [THC])
- Unstable hypertension (blood pressure > 160/100)
- Renal failure with active or pending hemodialysis
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04089982.
PRIMARY OBJECTIVE:
I. To determine whether varenicline versus (vs.) placebo shows greater reduction in laboratory-based smoking cue reactivity.
SECONDARY OBJECTIVES:
I. To determine whether varenicline vs. placebo shows greater reduction of cue reactivity during “real-world” testing.
II. To determine whether varenicline is more effective than placebo for achieving 7-day point prevalence smoking abstinence at the 2-weeks post target quit day (TQD) day visit.
III. To determine whether varenicline is more effective than placebo for smoking reduction over the 4-week pre-TQD smoking period and over the 2 week post-TQD period.
IV. To determine whether varenicline has acceptable adherence when compared to placebo in this population.
V. To determine tolerability through participant self-report.
EXPLORATORY OBJECTIVES:
I. To determine whether a variety of baseline variables (age, gender, sex, race, nicotine dependence, anxiety, depression, stress, baseline smoking enjoyment) are associated with differential treatment response between varenicline and placebo described within primary objective I and secondary objectives I-III.
II. To determine whether a variety of experiential or environmental variables (stress level, frustration, anger, sadness, boredom, positive affect, social interaction, time of day, familiar smoking place, smells, visual stimuli, alcohol use) are associated with our primary the intensity of cue reactivity for a particular cue and with smoking on a particular day.
III. To determine whether adherence to varenicline is associated with outcomes across multiple time points (2-weeks pre-TQD, 1-week pre-TQD, and 2-weeks post-TQD).
IV. To determine whether changes (baseline to each time point) in physical smoking satisfaction, pleasure from smoking or other forms of “smoking reward” are associated with differential treatment response in primary objective I and secondary objectives I-III (laboratory-based and real-world cue reactivity, smoking abstinence and reduction).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Beginning 4 weeks before the target quit day, participants undergo counseling over 20 minutes then receive varenicline orally (PO) twice daily (BID) over 6 weeks in the absence of disease progression or unacceptable toxicity. Participants also complete a cue reactivity test over 17 minutes and interact with a text-based program daily.
ARM 2: Beginning 4 weeks before the target quit day, participants undergo counseling over 20 minutes then receive placebo PO BID over 6 weeks in the absence of disease progression or unacceptable toxicity. Participants also complete a cue reactivity test over 17 minutes and interact with a text-based program daily.
In both arms, participants who attend the 2 week post quit day visit, are given the option to receive varenicline PO BID for an additional 6 weeks.
After completion of study treatment, participants are followed up 2-5 days after last medication.
Trial PhasePhase IV
Trial Typeprevention
Lead OrganizationDuke University Medical Center
Principal InvestigatorJames Davis
- Primary IDPro00103506
- Secondary IDsNCI-2019-07701
- ClinicalTrials.gov IDNCT04089982