We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sugars in Cigarettes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05308316
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To investigate a comprehensive set of abuse liability and appeal measures, smoking intensity, as well as analyze the impact of sugar content on the formation in the oral cavity of smokers of DNA adducts derived from aldehydes and oxidative stress.

Condition or disease Intervention/treatment Phase
Tobacco Use Other: Sucrose cigarettes Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Sugars on Tobacco Product Toxicity and Abuse Liability
Actual Study Start Date : February 24, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Impact of Sugar Content
Participants will be ask to attend 4 laboratory sessions during which they will be asked to smoke their usual brand (UB) cigarettes and then one of three study cigarettes with low, medium and high levels of sugar in separate sessions using a within-subject design with conditions counterbalanced determined by a Latin square. In each session, smokers will be asked to smoke a cigarette in a standardized manner (10 puffs,30 second interval between puffs) and 1 hour later, ad libitum. Each of the sessions will be separated by at least 48 hours but not more than 5 days.
 Other: Sucrose cigarettes
Winston brand cigarettes will be modified by adding a mixture of sucrose to each cigarette at 2 levels so that the amount of total (originally present and added) sugar content in these cigarettes matches median and highest levels found in popular brands analyzed


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To evaluate the impact of sugar content on behavioral measures [ Time Frame: End of Intervention (2-3 Weeks from enrollment) ]
    Evaluate the impact of sugar content on behavioral measures with either Modified Cigarette Evaluation Questionnaire (mCEQ) or The Multiple Choice Procedure task

  2. To evaluate the impact of sugar content on smoking intensity [ Time Frame: End of Intervention (2-3 Weeks from enrollment) ]
    Measure the amount of nicotine levels in the spend filters during the controlled puffing pattern.

  3. To evaluate the impact of sugar content on subjective responses to cigarettes (e.g., reinforcing and sensory effects) [ Time Frame: End of Intervention (2-3 Weeks from enrollment) ]
    Use the Sensory Effect of Smoking Questionnaire (SESQ) or Minnesota Nicotine Withdraw Scale (MNWS) to quantify


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female age 21 years or older
  • Smoking cigarettes that have been evaluated to have medium levels of sugar content
  • No quit attempts in the past month nor intentions to quit smoking in the next month
  • Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
  • Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
  • Stable vitals sign measurements (systolic BP ≤ 160 and >90 mmHg, diastolic BP ≤ 100 and >50 mmHg and heart rate ≤105 and > 45 bpm) as determined by the licensed medical professional
  • Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
  • Participants have provided written informed consent to participate in the study.

Exclusion Criteria:

  • Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
  • Women who are pregnant or nursing or planning to become pregnant.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308316


Contacts
Layout table for location contacts
Contact: Hanna Vanderloo, RN, MSN 612.624.4983 hannav@umn.edu

Locations
Layout table for location information
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Irina Stepanov, PhD University of Minnesota, Division of Environmental Health Sciences
Principal Investigator: Dorothy Hatsukami Masonic Cancer Center Tobacco Research Programs
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT05308316    
Other Study ID Numbers: 2020LS236
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No