Health TrialsbyHealthPanel

Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit

ConditionsCigarette SmokingTobacco UseCigarette Smoking Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

This study aims to investigate harm-reduction sampling in a choice format versus medicinal nicotine sampling on smoking behavior, identify mechanisms of sampling's effects, and explore moderators of these effects among a national sample of people unmotivated to quit smoking. Participants will be randomized 2:1 to choose one of two harm-reduction products (ECIG, ONP) versus a medicinal nicotine control condition (nicotine patch + lozenge, NPL), receive a 4-week starter product regimen, and then be followed for 6 months to assess use behavior.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to communicate fluently in English (i.e., speaking, writing, and reading)

Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.

Have a carbon monoxide (CO) greater than or equal to 10 ppm

Not using any forms of nicotine regularly other than cigarettes.

Disqualifiers

Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, IQOS, ONPS, etc.).

Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.

Current use of smoking cessation medication.

Provide a CO breath test reading less than 10 ppm at Intake.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRP Sampling period

    Other intervention

    During a 28-day sampling period, participants randomized to HRP are instructed to try their selected HRP (ECIGS or ONPs) and will complete daily e-diaries of cigarette smoking behavior and product uptake.

  • NPL Sampling period

    Other intervention

    During a 28-day sampling period, participants randomized to NPL are instructed to try nicotine patches and nicotine lozenges and will complete daily e-diaries of cigarette smoking behavior and product uptake.

Treatment groups

472 Participants
are divided into 2 treatment groups
Group A: Harm Reduction Products (HRP)Experimental treatment 1 intervention
Group B: Nicotine Patch and Lozenge (NPL)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Smoking abstinence

Seven-day point prevalence smoking abstinence (CO \< 5) will be measured at the 3-month (secondary endpoint) and 6-month follow-up (primary endpoint) via the valid and reliable TLFB procedure and biochemically verified through a CO \< 5 ppm.

Time frame
29 weeks

Secondary outcomes

1

Smoking reduction

Cigarette smoking rate and whether participants achieved a 50% change in cigarettes per day compared to their baseline smoking rate will be measured at the 3-month and 6-month follow-up via the valid and reliable TLFB procedure.

Time frame
29 weeks
2

24-hour quit attempts

24-hour quit attempts and the number (count) of serious attempts to quit smoking, including those lasting greater than or equal to 24 hours, will be captured through diaries during the sampling period and the TLFB during follow-up.

Time frame
29 weeks

Other outcomes

Sponsors and contacts

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

Abramson Cancer Center at Penn Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Pennsylvania

Collaborator

Source ClinicalTrials.gov
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