A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 21, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

May 30, 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

24 hour total urinary NNAL (mg/24 hours) excreted on Day 7.[ Time Frame: Day 7 ]

24 hour total urinary NNAL

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

24 hour urinary total total NNN, NE, 2-AN, 4-ABP, HEMA, CEMA, S-PMA, 3 HMPMA, 3-HPMA, 2-HPMA, AAMA, GAMA, 2-MHBMA, 2 OHFle, 2-Naphthol, 1 OHPhe, mutagenicity, and 1-OHP excreted on Day 5 and Day 7.[ Time Frame: Day 5 and 7 ]
24 hour urinary total total NNN, NE, 2-AN, 4-ABP, HEMA, CEMA, S-PMA, 3 HMPMA, 3-HPMA, 2-HPMA, AAMA, GAMA, 2-MHBMA, 2 OHFle, 2-Naphthol, 1 OHPhe, mutagenicity, and 1-OHP
24-hour urinary total NNAL excreted on Day 5.[ Time Frame: Day 5 ]
24-hour urinary total NNAL
COHb on Day 5 and Day 7.[ Time Frame: Day 5 and 7 ]
COHb
Questionnaire of Smoking Urges-Brief[ Time Frame: Day 1, 5 and 7 ]
The QSU-Brief is a 10-item instrument (Cox et al., 2001) intended to capture urge to smoke. Participants respond to the 10 items using a 7-point Likert-type rating scale ranging from Strongly Disagree to Strongly Agree. Both a total score (reflecting urge to smoke) and two factor scores (Factor 1: Intention to smoke with smoking perceived as rewarding; Factor 2: anticipation of relief from negative affect with an urgent desire to smoke) will be calculated by averaging the items.
Modified Cigarette Evaluation Questionnaire[ Time Frame: Day 1, 5 and 7 ]
The modified cigarette evaluation questionnaire (mCEQ) is a 12-item instrument intended to capture the degree to which a person experiences the reinforcing effects of smoking from 1 (Not at All) to 7 (Extremely) (Cappelleri et al., 2007). Scores for the five mCEQ subscales range from 1 to 7, with higher scores reflecting greater smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, and craving reduction.
Use the Product Again Questionnaire[ Time Frame: Day 7 ]
The "Use this Product Again Questionnaire" is a single-item bipolar visual analogue scale (VAS). Subjects are asked to respond to this item using a 100 mm VAS with three labeled points: "Definitely Would Not," "Don't Care" and "Definitely Would".
Product use behavior[ Time Frame: Day 1 to Day 7 ]
The number of each product used per day (cigarettes and OTDN products) and the duration of each OTDN product used during each product use period will be listed and summarized by study product.

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

Official Title ^ICMJE

A Randomized, Controlled, Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Partially or Completely Switch to Oral Tobacco-derived Nicotine Products in a Clinical Setting.

Brief Summary

The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.

Detailed Description

This is an open label, randomized, 6 parallel-group clinical study evaluating changes in exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers relative to continued smoking who are randomly assigned to continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Other: OTDN product 1
Oral tobacco-derived nicotine product
Other: OTDN product 2
Oral tobacco-derived nicotine product
Other: Tobacco Cessation
Tobacco Cessation

Study Arms

No Intervention: GROUP 1: Continue Smoking
Subjects will be asked to continue smoking their OB cigarettes ad libitum for 7 days.
Experimental: GROUP 2: OTDN product 1
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
Experimental: GROUP 3: OTDN product 2
Subjects will reduce their normal daily cigarette consumption by at least 50% of their baseline CPD and use at least 3 product units per day for 7 days.
Experimental: GROUP 4: OTDN product 1
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
Experimental: GROUP 5: OTDN product 2
Subjects will completely switch to exclusive use of an oral tobacco-derived nicotine product, using at least 3 product units per day for 7 days.
Experimental: GROUP 6: Tobacco Cessation
Subjects will completely stop all tobacco product usage for 7 days.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. Voluntary consent to participate in this study documented on the signed informed consent form (ICF). 2. Healthy adult males and females 21 to 65 years of age, inclusive, at Screening 3. Smoking history of an average of at least 10 but no more than 30 factory manufactured combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted. 4. Positive urine cotinine (≥ 500 ng/mL) at Screening. 5. Willing to comply with the requirements of the study. 6. Willing to use all test products after product trial at Check in. 7. Willing and able to abstain from cigarettes from Day 1 through the End of the study. Exclusion Criteria: 1. Use of any type of tobacco or nicotine containing products other than manufactured cigarettes (e.g., e vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to Check in 2. Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale). 3. Planning to quit smoking in the next 30 days (from Screening visit). 4. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 5. Clinically significant abnormal findings on the vital signs, physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Altria Client Services LLC

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Georgios D Karles, PhD Altria Client Services LLC

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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