Varenicline Light Smoking Pilot

Pilot Study on Varenicline in Light and Intermittent Smokers

The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue reactivity in light and intermittent smokers.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; Smoking Behaviors
• Intervention / Treatment: Drug: Placebo oral tablet; Drug: Varenicline

Detailed Description

The study will consist of randomization to receive either varenicline or placebo over 6 weeks and include 5 study visits. Participants are offered an optional additional 6 weeks of active varenicline. Cue reactivity will be assessed in both a lab-based setting (viewing series of images and rating cravings) and in a real-world setting (text-based daily interaction).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or above
2. Daily smoker using 10 or less cigarettes per day but a minimum of at least 1 cigarettes per week or 4 cigs/month.
3. Must be able to make it through a 24-hour period without nicotine withdrawal symptoms (specifically does not have new onset of irritability, headaches, insomnia, or intense cravings).
4. Willing to quit smoking in the next 30 days
5. 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.
6. 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.
7. 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.
8. Have access to a cell phone that can send and receive SMS text messages.

Exclusion Criteria:

1. Use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion) in last 30 days.
2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) in the last 30 days
3. Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
4. Active alcohol use disorder or hazardous drinking. This will be screened with the AUDIT-C, and positive scores (4 or greater for men and 3 or greater for women)54,55 will result in study clinician assessment and discretion.
5. Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, and/or methamphetamine)
6. Severe symptomatic depression and or anxiety (study medical provider discretion)
7. Diagnosis of bipolar disorder, schizophrenia, PTSD and or adult ADHD (study medical provider discretion)
8. Chronic medical illness including diabetes with the use of insulin, Hemoglobin A1c > 7 (study medical provider discretion), heart disease diagnosed by angiogram, or COPD diagnosed by pulmonary function testing and requiring an oxygen supply
9. Specific medications (Appendix 1)
10. Abnormal finding on physical exam (study medical provider discretion)
11. Positive Urine Pregnancy Test (women of child bearing potential only; QuickVue Urine Pregnancy)56
12. Positive Urine Toxicology-5 Screen (methamphetamine, cocaine, opiates, benzodiazepines, THC)
13. Unstable hypertension (Blood pressure > 160/100)
14. Renal failure with active or pending hemodialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo oral tablet; Placebo
Active Comparator: Varenicline; Varenicline BID	Drug: Varenicline; Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity	Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.	Baseline, Visit 4 (week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Reported Craving Level Via Real-World Cue Reactivity	Craving level in "real world" situations was assessed through electronic momentary assessment (EMA). Participants were instructed to send a text to the study team each time they experienced craving to smoke a cigarette. Self-report craving level to smoke was reported on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving.	Baseline, Visit 4 (week 6)
Changes in Smoking	7-day point prevalence smoking abstinence. This will be measured through self-reported daily smoking diaries and daily text messaging.	Screening visit, Visit 4 (week 6)
Medication Adherence	Medication adherence is measured by composite self-reported diaries and daily text messaging responses.	Screening visit, Visit 4 (week 6)
Medication Tolerance by Self-Reported Side Effects	Self-reported side effects (open ended survey questions) with a ranking scale of 1-2 (mild), 3-5 (moderate), and 6-7 (severe). Any side effect 3 or greater will be reviewed by a study medical provider.	Up to 12 weeks
Changes in Smoking Abstinence	7-day point prevalence smoking abstinence confirmed by CO <7ppm. This will be measured through biochemical confirmation (CO breath test).	Screening visit, Visit 4 (week 6)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: James Davis, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: Pro00103506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No