NCT04172623

Brief Summary

This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 26, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2.7 years

First QC Date

July 8, 2019

Results QC Date

April 25, 2022

Last Update Submit

February 9, 2023

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • Change in Cigarettes

    Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.

    Baseline and Week 8

Secondary Outcomes (1)

  • % Days Abstinent From Cigarettes

    Week 8

Study Arms (2)

Real-Time Smoking Intervention

EXPERIMENTAL

Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.

Behavioral: Real-Time Smoking InterventionBehavioral: Standard Treatment

Standard Treatment

ACTIVE COMPARATOR

Adult smokers will receive standard outpatient tobacco treatment.

Behavioral: Standard Treatment

Interventions

Real-Time Smoking InterventionBEHAVIORAL

Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.

Real-Time Smoking Intervention
Standard TreatmentBEHAVIORAL

Adult smokers will receive standard outpatient tobacco treatment.

Real-Time Smoking InterventionStandard Treatment

Eligibility Criteria

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

You may qualify if:

  • or older
  • Able to read English
  • Cigarette smoker
  • Seeking smoking cessation treatment

You may not qualify if:

  • Serious psychiatric or medical condition
  • Unable or unwilling to complete study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Krysten Bold, PhD
Organization
Yale School of Medicine
krysten.bold@yale.edu
2039747603

Study Officials

  • Krysten Bold, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

November 21, 2019

Study Start

June 1, 2019

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 13, 2023

Results First Posted

January 26, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)