NCT02515500

Brief Summary

The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

First Submitted

Initial submission to the registry

July 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

July 30, 2015

Last Update Submit

January 9, 2020

Conditions

Smoking Cessation

Keywords

cigarette reductiondigital healthmobile healthtechnologyQuitbitmHealthsmoking cessationquit smokingself-regulation

Outcome Measures

Primary Outcomes (1)

  • Saliva cotinine level

    6 Months

Study Arms (2)

Gradual Cessation

ACTIVE COMPARATOR
Behavioral: Gradual Cessation

Gradual Cessation w/ Quitbit

EXPERIMENTAL
Behavioral: Gradual Cessation w/ Quitbit

Interventions

Gradual CessationBEHAVIORAL
Also known as: Cigarette Reduction
Gradual Cessation
Gradual Cessation w/ QuitbitBEHAVIORAL
Also known as: Cigarette Reduction w/ Quitbit
Gradual Cessation w/ Quitbit

Eligibility Criteria

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

You may qualify if:

  • years of age
  • cigarette smoker
  • wanting to quit in the next 30 days
  • preference to quit gradually (vs. abruptly) or having no preference
  • access to an iPhone (iOS only)
  • completion of a run-in period

You may not qualify if:

  • no major change in number of cigarettes per day in the past month (+/- 20%)
  • no major health diagnoses that could impact study attrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Smoking CessationSelf-Control

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 4, 2015

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

US(1)