Effects of Nicotine in Tobacco Smokers | NCT03651869

Studies
Effects of Nicotine in Tobacco Smokers

NCT03651869

Sponsor

University of Southern California

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

221Actual

Phase

Phase 1

Conditions

Smoking, Tobacco
Smoking (Tobacco) Addiction

Interventions

Cigarette 1
Cigarette 2
Patch 1
Patch 2

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2019Actual

Primary Completion Date

Mar 23, 2023Actual

Completion Date

Mar 23, 2023Actual

First Submitted Date

Aug 23, 2018

First Submission Date that Met QC Criteria

Aug 27, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2023

Last Update Posted Date

Jul 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adam Leventhal, Professor of Preventive Medicine and Psychology, Director of the Health, Emotion, and Addiction Laboratory, University of Southern CaliforniaPrincipal Investigator

Lead Sponsor

University of Southern CaliforniaOTHER

Collaborators

Name	Class
Illinois Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Condition 1	Experimental	Drug: Cigarette 1 Drug: Patch 1
Condition 2	Experimental	Drug: Cigarette 2 Drug: Patch 1
Condition 3	Experimental	Drug: Cigarette 1 Drug: Patch 2
Condition 4	Experimental	Drug: Cigarette 2 Drug: Patch 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cigarette 1	Drug	Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)	Condition 1 Condition 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Smoking Urge	Smoking urge is measured using questionnaires that ask about a desire to smoke.	Throughout study completion, an average of two weeks.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 21 years old
Daily smoking at least 2 years

Exclusion Criteria:

Currently pregnant or breastfeeding.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam M Leventhal, PhD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Los Angeles	California	90033	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073869	Tobacco Smoking
D012907	Smoking
D016739	Behavior, Addictive

Ancestor Terms

ID	Term
D001519	Behavior
D064424	Tobacco Use
D003192	Compulsive Behavior
D007175	Impulsive Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000595790	Sugp2 protein, mouse

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided