Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04754867 |
Other study ID # |
STUDY2016_00000551 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2017 |
Est. completion date |
December 2017 |
Study information
Verified date |
February 2021 |
Source |
Carnegie Mellon University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Several factors are thought to be relevant to the level of adherence such as the initial
level of nicotine addiction (Orleans et al., 1994), gender (Gritz, Nielsen, & Brooks, 1996),
concerns over weight gain due to smoking cessation (Fagerström, 2002) and side effects (Burns
& Levinson, 2008). On the other hand, combining nicotine replacement treatment with
behavioral therapy has been shown to improve adherence and overall abstinence (Cooper et al.,
2004) and motivation is found to be an important factor related to patch use (Alterman,
Gariti, Cook, & Cnaan, 1999).
Can a more vivid connection to an individual's future self facilitate smoking cessation?
While behavioral interventions that enhance connection to the future self have been proven
effective at mitigating present bias, they have so far been done in domains that require
self-restraint (e.g., delinquency). Smoking cessation does in part require restraint, but a
cessation program utilizing the nicotine patch also requires proactive daily commitment and
action. Little research has been done to establish the effectiveness of a future selves
intervention on behaviors that require proactive action.
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. 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; 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.); participants in the current self
virtual reality condition will see their present age self in a virtual reality rendering.
Participants in all conditions will write a 200-300 word letter to themselves (in the
treatment condition, the letter is written to their self in 20 years; in control, the letter
is written to themselves in 3 months). The investigators will measure the impact of the
behavioral intervention on participants' expected efficacy with smoking cessation,
self-reported patch adherence, and smoking cessation success 2 and 8 weeks later.
The investigators will collect self-reported and non-invasive physiological adherence data
over the course of 8 weeks on participants' adherence to the nicotine patch (self-report) and
success with smoking cessation (self-report and CO analysis). For those participants
self-reporting zero cigarettes smoked in the 7 day period before lab visits, investigators
will administer a breath CO assessment (a simple procedure where the participant breathes
into a tube and the device analyzes how many carbon dioxide parts per million are in the
breath). The investigators will also asks participants if they would be willing to receive an
email invitation to an online, 3-question, 6-month follow-up survey to occur four months
after their last in-person visit to the laboratory.
The data collected will not be tied to identifiers; it will be used in statistical analyses
assessing the effects of the intervention.