Couples Dynamics and Smoking Cessation | NCT03885336

Studies
Couples Dynamics and Smoking Cessation

NCT03885336

Sponsor

University of Southern California

Status

Completed

Last Update Posted

Apr 20, 2023Actual

Enrollment

212Actual

Phase

Not provided

Conditions

Smoking
Smoking Cessation
Cessation, Smoking
Smoking Behaviors
Smoking, Cigarette

Interventions

No Interventions

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

Apr 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

Aug 26, 2018Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Mar 6, 2019

First Submission Date that Met QC Criteria

Mar 19, 2019

First Posted Date

Mar 21, 2019Actual

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

Apr 18, 2023

Last Update Posted Date

Apr 20, 2023Actual

Name	Class
American Cancer Society, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is about investigating smoking and attempts to quit smoking in couples. Participation will help determine better treatment efforts for couples who want to quit smoking. All study procedures will be conducted remotely, allowing couples to interact with study personnel through zoom.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Both-Quit Group		Couples in which both individuals smoke and both individuals would like to quit smoking.	Other: No Interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Interventions	Other	There are no interventions in this study. Participants are observed.	Both-Quit Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cigarette Craving	This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges.	Throughout study completion, an average of 28 days
Confidence in Quit Attempt	This measure is obtained through the completion of the Abstinence Self-Efficacy Questionnaire.	Throughout study completion, an average of 28 days
Mood	This measure is obtained through the completion of the Profile of Mood States Questionnaire.	Throughout study completion, an average of 28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Couples must be in a relationship for more than 6 months with no plans to separate or move in the next 30 days.
Participants must smoke at least 5 cigarettes per day for at least the past 2 years.

Exclusion Criteria:

English non-fluency.
Currently pregnant, nursing, or intend to become pregnant within the next 6 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Participants may live through the United States.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Kirkpatrick, 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
D012907	Smoking
D016540	Smoking Cessation
D000073865	Cigarette Smoking

Ancestor Terms

ID	Term
D001519	Behavior
D015438	Health Behavior
D000073869	Tobacco Smoking
D064424	Tobacco Use

Browse Leaves

Not provided

Browse Branches

Not provided