Health TrialsbyHealthPanel

The Options 2 Study

ConditionsSmokerSmoking Cessation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Wisconsin, Madison

About this trial

The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products.

Participants will:

* Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 21 years old (i.e., able to legally purchase tobacco products)

able to read and communicate in English

no plans to quit smoking in the next 30 days

willing to stop using nicotine replacement or varenicline

Disqualifiers

currently in treatment for psychosis or bipolar disorder

currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)

currently pregnant or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicotine Pouches

    Drug

    nicotine pouches

  • Mini Nicotine lozenges

    Drug

    mini lozenges

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: 3mg Nicotine PouchesExperimental treatment 1 intervention
Group B: 6mg Nicotine PouchesExperimental treatment 1 intervention
Group C: Nicotine Mini LozengesExperimental treatment 1 intervention
Group D: No Study ProductNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mean number of cigarettes smoked per day during the 21-day switching period.

Participants will self-report on their cigarette use

Time frame
Baseline to 3 weeks

Secondary outcomes

1

Change in cigarette craving

Participants will rate their craving for a cigarette using a 0-100 visual analog scale, where 0 = no craving and 100 = extreme craving after sampling their assigned study product after overnight abstinence from smoking

Time frame
Baseline to 3 weeks
2

Mean units of study product used per day during the 7-days prior to the switching period

Participants will report their study product use via EMA

Time frame
For 7-days leading up to the switching period
3

Mean units of study product used per day during the 21-day of the switching period

Participants will report their study product use via EMA

Time frame
21-days of the switching period

Other outcomes

Sponsors and contacts

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

University of Wisconsin, Madison

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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