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Effects of Nicotine in Tobacco Smokers

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651869
Recruitment Status : Suspended (Study recruitment temporarily suspended due to COVID-19 pandemic.)
First Posted : August 29, 2018
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Illinois Institute of Technology
Information provided by (Responsible Party):
Adam Leventhal, University of Southern California

Brief Summary:
This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.

Condition or disease Intervention/treatment Phase
Smoking, Tobacco Smoking (Tobacco) Addiction Drug: Cigarette 1 Drug: Cigarette 2 Drug: Patch 1 Drug: Patch 2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Condition 1 Drug: Cigarette 1
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)

Drug: Patch 1
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)

Experimental: Condition 2 Drug: Cigarette 2
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)

Drug: Patch 1
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)

Experimental: Condition 3 Drug: Cigarette 1
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)

Drug: Patch 2
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)

Experimental: Condition 4 Drug: Cigarette 2
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)

Drug: Patch 2
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)




Primary Outcome Measures :
  1. Smoking Urge [ Time Frame: Throughout study completion, an average of two weeks. ]
    Smoking urge is measured using questionnaires that ask about a desire to smoke.



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.


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

Inclusion Criteria:

  • At least 21 years old
  • Daily smoking at least 2 years

Exclusion Criteria:

  • Currently pregnant or breastfeeding.

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): NCT03651869


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Illinois Institute of Technology
Investigators
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Principal Investigator: Adam M Leventhal, PhD University of Southern California
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Responsible Party: Adam Leventhal, Professor of Preventive Medicine and Psychology, Director of the Health, Emotion, and Addiction Laboratory, University of Southern California
ClinicalTrials.gov Identifier: NCT03651869    
Other Study ID Numbers: 28IR-0063
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Adam Leventhal, University of Southern California:
Smoking
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior