EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/21/2018 |
| Start Date: | October 1, 2017 |
| End Date: | August 2021 |
| Contact: | Larry Hawk |
| Email: | lhawk@buffalo.edu |
| Phone: | 716-645-0192 |
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.
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.
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.
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