Health TrialsbyHealthPanel

Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

ConditionsSmoking CessationObesity and Obesity-related Medical Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBrown University

About this trial

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)

smoked ≥ 5 cigarettes/day during the past year

21 or older (due to minimum legal age EC restrictions)

exhaled breath carbon monoxide (CO) level > 6 ppm at Baseline (BL) (to confirm self-reported smoking)

Disqualifiers

received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),

currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)

hospitalized for mental illness in past 30 days

heart-related event (e.g., heart attack, severe angina) in past 30 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electronic Cigarettes (EC)

    Other intervention

    Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to EC for 8 weeks, with EC provided.

  • Nicotine replacement therapy (NRT)

    Other intervention

    Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to combination NRT (transdermal + oral) for 8 weeks, with NRT provided.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Electronic Cigarette (EC) ConditionExperimental treatment 1 intervention
Group B: Nicotine Replacement Therapy ConditionExperimental treatment 1 intervention
Group C: No-Product Control Condition (CON)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

number of cigarettes per day

Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.

Time frame
2 months
2

carbon monoxide (CO)

Exhaled breath sample used to measure carbon monoxide

Time frame
2 months
3

number of quit attempts

Number of attempts to quit smoking during the experimental period

Time frame
2 months

Secondary outcomes

1

product acceptability

Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)

Time frame
2 months
2

product adherence

Percentage of days using the alternative nicotine product assigned (if applicable)

Time frame
2 months
3

change in weight

change in body weight (lbs) from baseline to 2 months

Time frame
2 months
4

change in waist circumference

change in waist circumference, a measure of central adiposity, from baseline to 2 months

Time frame
2 months

Other outcomes

Sponsors and contacts

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

Brown University

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov
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