NCT04754867

Brief Summary

The goal of this experimental research is to increase adherence to a smoking cessation patch among Pittsburgh residents who are trying to quit smoking. The literature on smoking cessation shows that there is a significant problem with adherence when using a transdermal patch as a nicotine replacement treatment. Less than half of patients use the patch as prescribed and adherence suffers a rapid decline during the first six weeks of treatment (Waldroup, Gifford, \& Kalra, 2006). Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Status
withdrawn

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

September 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

September 20, 2017

Last Update Submit

February 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adherence at two weeks

    In the past 2 weeks, how often did you wear a nicotine patch?

    Two weeks after initial intervention

  • Adherence at eight weeks

    In the past 2 weeks, how often did you wear a nicotine patch?

    Eight weeks after initial intervention

Secondary Outcomes (4)

  • Abstinence at two weeks

    Two weeks after initial intervention

  • Abstinence at eight weeks

    Eight weeks after initial intervention

  • CO ppm at two weeks

    Two weeks after initial intervention

  • CO ppm at eight weeks

    Eight weeks after initial intervention

Study Arms (3)

"discontinued-smoker" age-progressed

EXPERIMENTAL

Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view.

Behavioral: Future Self Virtual Reality Image - Normal AgingBehavioral: Letter - 20 years

"discontinued-smoker" + "continued smoking" age-progressed

EXPERIMENTAL

Participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.).

Behavioral: Future Self Virtual Reality Image - Normal AgingBehavioral: Future Self Virtual Reality Image - Smoking Consequences AgingBehavioral: Letter - 20 years

Current self virtual reality images

EXPERIMENTAL

Participants in the current self virtual reality condition will see their present age self in a virtual reality rendering.

Behavioral: Current Self Virtual Reality ImageBehavioral: Letter - 3 months

Interventions

Using software developed for this purpose, a current photograph of the subject will be aged and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar.

"discontinued-smoker" + "continued smoking" age-progressed"discontinued-smoker" age-progressed

Using software developed for this purpose, a current photograph of the participant will be aged showing the results of continued smoking and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar.

"discontinued-smoker" + "continued smoking" age-progressed

Using software developed for this purpose, a current photograph of the participant will be rendered as a 3D virtual reality avatar.

Current self virtual reality images

Participants will write a 200-300 word letter to the self they see in that image in 20 years' time. The instructions will read: "Think about who you will be in 20 years from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?"

"discontinued-smoker" + "continued smoking" age-progressed"discontinued-smoker" age-progressed

Participants will write a 200-300 word letter to the self they see in that image. The instructions will read: "Think about who you will be in 3 months from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?"

Current self virtual reality images

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Considering enrollment or recently enrolled (within 1 week) in one of the three designated smoking cessation programs

You may not qualify if:

  • Use of any form of tobacco other than cigarettes
  • Use of nicotine gum
  • History of alcohol or drug dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

February 15, 2021

Study Start

October 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share