Effects of Nicotine in Tobacco Smokers

July 11, 2023 updated by: Adam Leventhal, University of Southern California

Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Currently pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Patch 1
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
Drug: Cigarette 2
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout study completion, an average of two weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Illinois Institute of Technology

Investigators

  • Principal Investigator: Adam M Leventhal, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28IR-0063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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