Switch or Quit R01

ConditionsCigarette Smoking Smoking Behaviors

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorMedical University of South Carolina

About this trial

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.

Interest in reducing harms from tobacco use or quitting smoking

Disqualifiers

Pregnant, breastfeeding, or trying to become pregnant.

Household member currently enrolled in the study

Planning to move out of the area within the next 7 months

Trial design

Design model

Parallel

Treatments tested in this trial

Switching to E-Cigarette
Behavioral
Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
Switching using Medication
Behavioral
Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date

Treatment groups

225 Participants

are divided into 2 treatment groups

Group A: Choice of MedicationExperimental treatment 1 intervention

Group B: Choice of E-CigaretteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback

Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide \< 6 ppm

Time frame

11 Weeks

Secondary outcomes

Greater than 50% reduction in cigarette smoking

Average reduction in the number of cigarettes smoked per day on 7-day timeline followback at Week 11 of at least 50% or greater compared to average baseline number of cigarettes smoked per day on 7 day timeline followback

Time frame

11 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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