Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04130698 |
Other study ID # |
1819-1483 |
Secondary ID |
R15DA045917-01A1 |
Status |
Withdrawn |
Phase |
Phase 1/Phase 2
|
First received |
|
Last updated |
|
Start date |
June 1, 2019 |
Est. completion date |
July 31, 2022 |
Study information
Verified date |
October 2022 |
Source |
Rhode Island College |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study has two phases. In Phase 1, the investigators will revise and pilot the distress
tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20
GM103430, Spas, PI). Despite the 4-week post-intervention treatment outcomes demonstrating
the DT protocol's association with smoking cessation and weight loss, several revisions to
the DT protocol are important to improve the intervention. First, the investigators will
include the overweight/obese smokers' group-level feedback that the investigators collected
during the 7-week intervention and at the 4-week post-intervention individual interviews to
tailor the DT protocol to meet the unique needs of smokers with excess weight. Subjects from
the previous study revealed factors that led to current and/or previous successful smoking
cessation and weight loss efforts, barriers to sustaining current and/or previous successful
smoking cessation and weight loss efforts, and general feedback about DT intervention for
both health risks. The investigators believe revising the DT protocol to include
overweight/obese smokers' unique experience with the novel intervention and their acumen
about these key factors will improve the intervention and its generalizability to smokers
with excess weight. Additional revisions are described elsewhere. After the investigators
pilot the revised DT protocol, the investigators will revise the active health control
protocol comprised of standard treatment for smoking cessation and weight loss to ensure both
protocols equate for intervention contact time. Although both protocols will have some
similar content, to avoid any threats to internal validity, no DT-specific material will be
included in the control. In Phase 2, the investigators will conduct a two-armed, preliminary
randomized controlled trial (RCT) to compare the revised DT protocol's efficacy to the active
health control protocol.
Description:
In Phase 1, the investigators will revise the distress tolerance (DT) protocol the
investigators developed in a previous study. Currently, the DT protocol is comprised of 6
two-hour weekly group sessions. However, based on the data the investigators collected in the
previous study, the investigators will revise the DT protocol to have 7 instead of 6 two-hour
weekly group sessions. 6 subjects (1 group) will be recruited to pilot the revised DT
protocol. All subjects in the pilot will receive the transdermal nicotine patch (TNP). Prior
to initiating use of the TNP on quit day, all subjects will be educated about its use and
instructed to comply with all the recommended guidelines for usage as outlined in the
directions. Smokers who lapse during treatment will be encouraged to set a new quit date and
continue to attempt to quit. Subjects who continue to smoke or lapse after quit day will not
be instructed to discontinue the patch unless their smoking level reaches 4 cigarettes/day
for 4 days. This recommendation is consistent with safe TNP use. Smoking cessation will be
objectively verified by expired carbon monoxide levels and saliva cotinine assays.
Specifically, subjects who self-report nicotine abstinence will provide an exhaled breath
into a Bedfont Micro Smokerlyzer to measure carbon monoxide levels and provide an adequate
amount of saliva for cotinine analyses. RAs will wear non-latex gloves and follow all safety
protocols for data collection and storage for biochemical materials. the investigators will
use an 8ppm cutoff for expired carbon monoxide levels for stated abstinence of 24 hours for 2
weeks and use a cutoff of 10ng/ml for saliva cotinine assays for stated abstinence of 2 weeks
or more as cotinine may be incompletely metabolized before this time. Expired carbon monoxide
results will be immediately available. Saliva samples will be frozen for shipment to the
American Health Foundation (Valhalla, NY) for cotinine level determination by radioimmune
assay. Detected values above the stated cutoffs will be considered indicative of smoking.
Therefore, smoking cessation and weight loss will be assessed using expired carbon monoxide
and weigh-ins during the intervention and saliva cotinine assays and weigh-ins at follow-ups.
During Phase 1 post-intervention follow-up, the investigators will revise the active health
control protocol comprised of standard treatment for smoking cessation and weight loss to
make sure it equates for intervention contact time.
In Phase 2, 48 subjects (8 groups of 6) will be recruited. Both conditions will receive the
TNP and follow the protocol previously outlined in Phase 1. Once 6 eligible subjects are
recruited, random assignment will be used to determine which of the two treatment conditions
the group will receive. We expect to recruit 6 subjects within two weeks, reducing the lag
time between a subject's eligibility and starting the intervention. Compensation for
subjects' time will also support timely recruitment. To ensure an equal number of groups are
assigned to each of the two conditions, assignment will be completed by choosing from among a
fixed pool of 8 entries (4 from each condition). Smoking cessation and weight loss outcomes
will be assessed using biochemical measures and weigh-ins during the intervention and at
follow-up.