Nicotine Oral Product for Smoking

Recruiting at 1 trial location

Overseen By Emily Smith

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RAI Services Company

Must not be taking: Smoking cessation aids

Disqualifiers: Diabetes, Cancer, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a two-site, open-label, randomized, 8-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.

Research Team

Brian Keyser, PhD

Principal Investigator

Reynolds American

Eligibility Criteria

This trial is for generally healthy smokers aged 21-60 who also use smokeless tobacco products. They must have smoked at least 10 cigarettes a day for the past 6 months, be willing to use specific nicotine products during the study, and stay in-clinic for ten days. Pregnant women or those on certain medications are excluded.

Inclusion Criteria

I have used smokeless tobacco products within the last 30 days.

Females must be willing to use a form of contraception acceptable to an investigator from the time of signing the ICF until End-of-Study

Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English

Exclusion Criteria

Individuals or their family members that have ongoing litigation with tobacco company(ies)

Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening or at check-in Day -1

I weigh 110 pounds or less.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 45 days

1 visit (in-person)

In-Clinic Confinement

Participants are confined for 10 days to evaluate elements of abuse liability of nicotine products

10 days

Continuous in-clinic stay

Test Sessions

Participants evaluate one investigational product in each of eight separate test sessions, including subjective and physiological measures

8 days

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the test sessions

4 weeks

Treatment Details

Interventions

• Modern Nicotine Oral Product

Trial Overview The study tests eight different oral nicotine products (Product A to N) to see how they affect users' desire and body reactions compared to their usual smoking habits. It's an open-label study where participants know what they're using, with each trying all options in random order.

Participant Groups

Group I: Product usage order NGAFBECD Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group II: Product usage order GFNEADBC Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group III: Product usage order FEGDNCAB Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group IV: Product usage order EDFCGBNA Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group V: Product usage order DCEBFAGN Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group VI: Product usage order CBDAENFG Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group VII: Product usage order BACNDGEF Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group VIII: Product usage order ANBGCFDE Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Who Is Running the Clinical Trial?

RAI Services Company

Lead Sponsor

Trials

43

Recruited

7,700+