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Behavioral Intervention
Therapy and Varenicline for Tobacco Use
Phase 2
Waitlist Available
Led By Chiang-Shan Li
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report heavy tobacco use (including nicotine e-cigarettes) for more than 1 year
Be between 18 and 65 years old
Must not have
Women who are pregnant or nursing
Medical contraindications for fMRI, varenicline, and/or behavioral treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, 8, 12, and 26
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if therapy and counseling can help adults quit smoking by making them feel better emotionally and improving their self-control. They also want to find out what changes happen in the brain during this
Who is the study for?
This trial is for adult smokers who have been using tobacco heavily for over a year, including e-cigarettes, and are not currently pregnant or nursing. Participants must speak English, have an optimal body mass index, and not be enrolled in other treatments. They should not have neuropsychiatric conditions or other factors that cause poor sleep which could affect the study.
What is being tested?
The study tests if behavioral interventions can help adult smokers quit by reducing negative emotions and boosting self-control. It also looks to identify brain activity markers of these effects. The intervention includes Varenicline medication alongside experimental health strategies.
What are the potential side effects?
Varenicline may cause nausea, sleep problems (including vivid dreams), constipation, gas, vomiting; changes in taste; dry mouth; headache; drowsiness (sleepiness); tiredness (fatigue); increased appetite.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have used tobacco heavily for over a year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or nursing.
Select...
I cannot have an fMRI or take varenicline due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Days to smoking relapse
Mean number cigarettes smoked per day
Quit status
+1 moreSecondary study objectives
Change in Insomnia Severity Index
Change in PROMIS Sleep Disturbance
Change in PROMIS Sleep-Related Impairment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental health interventionExperimental Treatment2 Interventions
Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
Group II: Control health interventionActive Control1 Intervention
Control health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,912 Previous Clinical Trials
3,039,358 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,566 Previous Clinical Trials
3,258,033 Total Patients Enrolled
Chiang-Shan LiPrincipal InvestigatorYale University
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