Back to resultsEffects of Nicotine in Tobacco Smokers
Primary Purpose
Smoking, Tobacco, Smoking (Tobacco) Addiction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cigarette 1
Cigarette 2
Patch 1
Patch 2
Sponsored by
About this trial
This is an interventional basic science trial for Smoking, Tobacco focused on measuring Smoking
Eligibility Criteria
Inclusion Criteria:
- At least 21 years old
- Daily smoking at least 2 years
Exclusion Criteria:
- Currently pregnant or breastfeeding.
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Condition 1
Condition 2
Condition 3
Condition 4
Arm Description
Outcomes
Primary Outcome Measures
Smoking Urge
Smoking urge is measured using questionnaires that ask about a desire to smoke.
Secondary Outcome Measures
Full Information
NCT ID
NCT03651869
First Posted
August 23, 2018
Last Updated
July 11, 2023
Sponsor
University of Southern California
Collaborators
Illinois Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03651869
Brief Title
Effects of Nicotine in Tobacco Smokers
Official Title
Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Illinois Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco, Smoking (Tobacco) Addiction
Keywords
Smoking
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Condition 1
Arm Type
Experimental
Arm Title
Condition 2
Arm Type
Experimental
Arm Title
Condition 3
Arm Type
Experimental
Arm Title
Condition 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cigarette 1
Intervention Description
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
Intervention Type
Drug
Intervention Name(s)
Cigarette 2
Intervention Description
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
Intervention Type
Drug
Intervention Name(s)
Patch 1
Intervention Description
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
Intervention Type
Drug
Intervention Name(s)
Patch 2
Intervention Description
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
Primary Outcome Measure Information:
Title
Smoking Urge
Description
Smoking urge is measured using questionnaires that ask about a desire to smoke.
Time Frame
Throughout study completion, an average of two weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 21 years old
Daily smoking at least 2 years
Exclusion Criteria:
Currently pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam M Leventhal, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Nicotine in Tobacco Smokers
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