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Nicotinic Acetylcholine Receptor Partial Agonist
Varenicline for Vaping (Pilot Trial)
Phase 4
Waitlist Available
Led By Eden Evins, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-25 inclusive;
Able to understand study procedures and read and write in English;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 9-24
Awards & highlights
Pilot Trial Summary
This study is evaluating whether a medication may help teens who vape to quit.
Eligible Conditions
- Vaping
- Nicotine Addiction
Pilot Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPilot Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 9-24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 9-24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of vaping abstinence
Latency to first lapse
Latency to relapse
+5 moreSecondary outcome measures
Intensity of nicotine craving
Nicotine withdrawal symptoms
Therapeutic procedure
+2 moreOther outcome measures
Amount of substances other than nicotine consumed
Side effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Headache
21%
Depression
21%
Agitation
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Fatigue
7%
Leg Spasms
7%
Panic
7%
Confusion
7%
Increased Blood Pressure
7%
Stomach Pain
7%
Dizziness
7%
Palpitations
7%
Aggression
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Sinusitis
7%
Leg Cramps
7%
Muscle Pain
7%
Cellulitis
7%
Rash
7%
Angina
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline
Pilot Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VareniclineExperimental Treatment1 Intervention
Participants will receive varenicline 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation
Group II: Monitoring onlyActive Control1 Intervention
Participants will attend weekly and monthly sessions that will only consist of assessments. No study medication, no behavioral or texting support.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive identical placebo 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation
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?
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,831 Total Patients Enrolled
2 Trials studying Vaping
300 Patients Enrolled for Vaping
National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,594,062 Total Patients Enrolled
9 Trials studying Vaping
5,066 Patients Enrolled for Vaping
Eden Evins, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Vaping
300 Patients Enrolled for Vaping
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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