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EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking (EVarQuit)

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ClinicalTrials.gov Identifier: NCT03262662
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
Larry Hawk, Ph.D., State University of New York at Buffalo

Brief Summary:
Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Drug: Varenicline Behavioral: Brief smoking cessation counseling Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Extended Run-In

** 4 weeks of varenicline prior to the target quit date (TQD) **

+ 11 weeks of post-TQD varenicline

Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.

Brief individual counseling at clinic visits

Drug: Varenicline
oral varenicline tablets
Other Name: Chantix

Behavioral: Brief smoking cessation counseling
~10-minute individual counseling at each of 6 clinic visits

Active Comparator: Standard Run-In

** 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) **

+ 11 weeks of post-TQD varenicline

Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.

Brief individual counseling at clinic visits

Drug: Varenicline
oral varenicline tablets
Other Name: Chantix

Behavioral: Brief smoking cessation counseling
~10-minute individual counseling at each of 6 clinic visits




Primary Outcome Measures :
  1. Continuous abstinence [ Time Frame: Self-report Weeks 8-11 post-TQD; bio-verification at Week 12 ]
    Bio-verified self-report of continuous abstinence from smoking during the final four weeks of treatment


Secondary Outcome Measures :
  1. Pre-quit reduction in smoking [ Time Frame: From baseline (5 weeks before TQD) through final week before TQD ]
    Percent reduction in smoking behavior (cigarettes per day; CPD) during the pre-quit phase of the study.

  2. Continuous abstinence [ Time Frame: Self-report Weeks 8-25 post-TQD; bio-verification at Week 12 and Week 26 ]
    Bio-verified self-report of continuous abstinence from smoking during the final four weeks of treatment through six month followup



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Approximately equal numbers of men and women will participate.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoking at least 10 cigarettes per day for the past 6 months and expired-air carbon monoxide (CO) >7 at intake.
  • At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
  • Planning to remain in western New York (NY) during the study period
  • Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
  • English speaker
  • To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.

Exclusion Criteria:

  • Use of other tobacco products, including e-cigarettes, in past 7 days
  • Use of smoking cessation medication, including nicotine replacement therapy, in the past 14 days
  • Prior allergy/hypersensitivity to varenicline
  • Pregnant or breast-feeding
  • Substance use:

    • Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and warranting treatment; for those with scores between 8 and 15, the investigators will advise reducing drinking).
    • Medical treatment for substance use in past 3 months, including Suboxone (buprenorphine) and methadone (at phone screen)
    • Using a combination of the National Institute on Drug Abuse (NIDA) modified ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both at intake):

      • Cannabis: ASSIST=27+ (tox screen not used)
      • Cocaine: ASSIST=7+ OR positive tox screen
      • Methamphetamine: ASSIST=7+ OR positive tox screen
      • Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+
      • Prescription stimulants: With prescription, ASSIST 27+; Without prescription, ASSIST 7+
      • Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive tox screen

(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems. clinicaltrials.gov edited 12/18/18)

  • Psychiatric:

    • Antipsychotic medications
    • Lifetime history of schizophrenia or bipolar disorder
    • Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at intake
    • Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating (Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is > 2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide preparatory acts or behavior on the C-SSRS).
  • Any medical condition, illness, disorder or concomitant medication that compromises participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  • Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262662


Contacts
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Contact: Larry Hawk 716-645-0192 lhawk@buffalo.edu

Locations
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United States, New York
State University of New York at Buffalo Recruiting
Buffalo, New York, United States, 14260
Contact: Larry W Hawk, PhD         
Sponsors and Collaborators
State University of New York at Buffalo
National Cancer Institute (NCI)
Pfizer

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Responsible Party: Larry Hawk, Ph.D., Professor, Department of Psychology, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03262662     History of Changes
Other Study ID Numbers: STUDY00000911
R01CA206193 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs