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

Tobacco Use Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692078
• Other study ID #: ALCS-RDS-18-04-VRV
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Altria Client Services LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Use

Intervention

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

Locations

Country	Name	City	State
United States	Inflamax - Hill Top Research	Neptune	New Jersey
United States	QPS Bio-Kinetic Clinical Applications, LLC	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Altria Client Services LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour total urinary NNAL (mg/24 hours) excreted on Day 7.	24 hour total urinary NNAL	Day 7
Secondary	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.	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	Day 5 and 7
Secondary	24-hour urinary total NNAL excreted on Day 5.	24-hour urinary total NNAL	Day 5
Secondary	COHb on Day 5 and Day 7.	COHb	Day 5 and 7
Secondary	Questionnaire of Smoking Urges-Brief	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.	Day 1, 5 and 7
Secondary	Modified Cigarette Evaluation Questionnaire	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.	Day 1, 5 and 7
Secondary	Use the Product Again Questionnaire	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".	Day 7
Secondary	Product use behavior	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.	Day 1 to Day 7