The Impact of Successful Quitting Smoking After Intensive... | NCT06967636

Studies
The Impact of Successful Quitting Smoking After Intensive Smoking Cessation Interventions on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish Smoking Cessation Database

NCT06967636

Sponsor

Parker Research Institute

Status

Completed

Last Update Posted

May 13, 2025Actual

Enrollment

15,863Actual

Phase

Not provided

Conditions

Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description
STOPbase	Registry Identifier	The STOPbase - The Danish smoking cessesation databse
NPR	Registry Identifier	NPR - The Danish National Patient Register
RCD	Registry Identifier	RCD - The Danish National Registry of Causes of Death

Status Module

Record Verification Date

May 2025

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

Jan 1, 2006Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

May 5, 2025

First Submission Date that Met QC Criteria

May 5, 2025

First Posted Date

May 13, 2025Actual

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

May 5, 2025

Last Update Posted Date

May 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

We evaluate intensive smoking cessation interventions (GSP) on morbidity and mortality in terms of assessing the impact among quitters and non-quitters with severe mental disorders (SMD)

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

15,863Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause morbidity	Days of hospital contact of all causes	January 2006 to January 2020
All-cause mortality	Death from all causes	January 2006 to January 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

F20-F29, F30-F39, F60-F69, F10-F16, F18, F19
Participation in the GSP in Denmark

Exclusion Criteria:

Dual diagnosis (F00-F99 and a co-occurring substance-use disorder (F10-F16, F18, F19)
< 18 years
No consent to follow-up
No baseline smoking status

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All participants >18 years with a severe mental disorder (SMD) undergoing the GSP in Denmark at local clinics with consent to follow up.

Sampling Method

Non-Probability Sample

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D015438	Health Behavior
D001519	Behavior