NCT05738408

Brief Summary

The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

June 6, 2022

Last Update Submit

January 16, 2025

Conditions

Smoking Cessation

Keywords

smoking cessationsecondary prevention

Outcome Measures

Primary Outcomes (1)

  • Biochemical verification of smoking status

    Assess the efficacy of combined FI+NRT vs. UC on biochemically verified smoking abstinence

    3 months

Secondary Outcomes (1)

  • Cardiovascular Fitness

    3 months

Other Outcomes (12)

  • Smoking Characteristics

    3 months

  • Smoking Characteristics

    3 months

  • Smoking Characteristics

    3 months

  • +9 more other outcomes

Study Arms (2)

Control: Usual Care

NO INTERVENTION

will receive standard treatment which entails referral to Vermont Quit Network. This network offers a wide range of free cessation services, including NRT and web-based modules on preparing to quit and developing a plan

Intervention: Financial incentives and nicotine replacement therapy intervention

EXPERIMENTAL

an intervention where patients are assigned to financial incentives and NRT of their choice; use of CO monitor to assess abstinence

Behavioral: Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)

Interventions

Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)BEHAVIORAL

: In the intervention condition, patients will receive both NRT plus a 12-week program of monetary incentives for verified smoking abstinence that will be implemented by our clinic staff

Intervention: Financial incentives and nicotine replacement therapy intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be recruited if they:
  • Hospitalization for an acute coronary event which includes myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass)
  • live within 30 miles of UVMMC and are \>18 years of age
  • Current cigarette smoker (defined as reporting any use of cigarettes in the week before admission and \>5 cigarette/day on average over the past 3 months)

You may not qualify if:

  • Patients will be excluded if they have:
  • severe dementia/Alzheimer's disease
  • an active malignancy, excluding non-melanoma skin cancer or low-grade prostate cancer under active surveillance
  • exercise limiting vascular or neuromuscular disease
  • Non-English Speaking
  • No reliable smart-phone
  • Current, regular use of smokeless tobacco or other form of non-combusted tobacco

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Sherrie Khadanga, MD

CONTACT

802-847-2700sherrie.khadanga@uvmhealth.org

Diann Gaalema, PhD

CONTACT

diann.gaalema@med.uvm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 6, 2022

First Posted

February 22, 2023

Study Start

August 12, 2022

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

January 20, 2025

Record last verified: 2025-01

Locations

US(1)