Varenicline Light Smoking Pilot

NCT04089982 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00103506
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation; Smoking Behaviors; Smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Self-Reported Craving Level Via Real-World Cue Reactivity

  Baseline, Visit 4 (week 6)

• Changes in Smoking

  Screening visit, Visit 4 (week 6)

• Medication Adherence

  Screening visit, Visit 4 (week 6)

• Medication Tolerance by Self-Reported Side Effects

  Up to 12 weeks

• Changes in Smoking Abstinence

  Screening visit, Visit 4 (week 6)

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Varenicline BID

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral tablet

Interventions

Varenicline DRUG

Chantix

Varenicline

Placebo oral tablet DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• Daily smoker using 10 or less cigarettes per day but a minimum of at least 1 cigarettes per week or 4 cigs/month.
• 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).
• 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 SMS text messages.

You may not qualify if:

• Use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion) in last 30 days.
• Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) in the last 30 days
• Answer \> 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
• 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.
• 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, PTSD and or adult 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 COPD diagnosed by pulmonary function testing and requiring an oxygen supply
• Specific medications (Appendix 1)
• Abnormal finding on physical exam (study medical provider discretion)
• Positive Urine Pregnancy Test (women of child bearing potential only; QuickVue Urine Pregnancy)56
• Positive Urine Toxicology-5 Screen (methamphetamine, cocaine, opiates, benzodiazepines, THC)
• Unstable hypertension (Blood pressure \> 160/100)
• Renal failure with active or pending hemodialysis

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: James M. Davis, MD
• Organization: Duke University

james.m.davis@duke.edu

919-668-5055

Study Officials

• James Davis, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: SPONSOR

Model Details: 2-arm randomized, placebo-controlled trial

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: November 4, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)