Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03808714 |
| Other study ID # |
IRB-160204003 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2016 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Our preliminary data shows that 39.9% of AA men between 19 and 30 years of age who resided in
rural Alabama smoke cigarettes. Although it has been well established that a combination of
pharmacotherapy and advice-oriented counseling and/or cognitive behavioral interventions are
efficacious in promoting smoking cessation across diverse populations, these evidence-based
treatments for tobacco dependence have not proven to be effective/efficacious (or even
accessible) among some subpopulations suffering disproportionally from tobacco-related
morbidity and mortality. The overall goal of this feasibility study is to make adaptations to
these evidence-based approaches, and develop, implement, and examine the feasibility and
scalability of a theory-based, culturally relevant smoking cessation intervention for young
adult AA men in rural Alabama who smoke cigarettes. Our formative assessments point to a
cognitive-behavioral intervention delivered by a trained Community Health Worker with the
support from an "expert" physician who can deliver the pharmacological component via Skype
through an integrated approach. The proposed study will address the next three steps in this
process: development of the intervention, pretesting, and feasibility. First, we will develop
the intervention with input from a Community Advisory Committee, followed by an iterative
process by which the target audience will be exposed to materials and messages to provide
feedback (pretesting). Once all intervention components are finalized, we will recruit
participants, randomly assign them to intervention/control groups, pilot test, and evaluate
the intervention. The comparison group will be the Alabama Tobacco Quitline with 8 weeks of
Nicotine Replacement Therapy to be consistent with the pharmacological approach proposed for
the intervention. The primary outcome will be 7-day point prevalence abstinence (defined as
no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide
levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and
scalability assessments (acceptability, feasibility, potential reach and adoption, alignment
with the strategic context) to inform a full-scale efficacy trial.
Description:
Despite smoking fewer cigarettes daily, African American (AA) men suffer higher morbidity and
mortality associated with tobacco-related disorders than whites. Our preliminary data shows
that 39.9% of AA men between 19 and 30 years of age who resided in rural Alabama smoke
cigarettes. Although it has been well established that a combination of pharmacotherapy and
advice-oriented counseling and/or cognitive behavioral interventions are efficacious in
promoting smoking cessation across diverse populations, these evidence-based treatments for
tobacco dependence have not proven to be effective/efficacious (or even accessible) among
some subpopulations suffering disproportionally from tobacco-related morbidity and mortality.
The overall goal of this feasibility study is to make adaptations to these evidence-based
approaches, and develop, implement, and examine the feasibility and scalability of a
theory-based, culturally relevant smoking cessation intervention for young adult AA men in
rural Alabama who smoke cigarettes. Our formative assessments point to a cognitive-behavioral
intervention delivered by a trained Community Health Worker with the support from an "expert"
physician who can deliver the pharmacological component via Skype through an integrated
approach. The proposed study will address the next three steps in this process: development
of the intervention, pretesting, and feasibility. First, we will develop the intervention
with input from a Community Advisory Committee, followed by an iterative process by which the
target audience will be exposed to materials and messages to provide feedback (pretesting).
Once all intervention components are finalized, we will recruit participants, randomly assign
them to intervention/control groups, pilot test, and evaluate the intervention. The
comparison group will be the Alabama Tobacco Quitline with 8 weeks of Nicotine Replacement
Therapy to be consistent with the pharmacological approach proposed for the intervention. The
primary outcome will be 7-day point prevalence abstinence (defined as no cigarettes in the
past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month
follow-up. We will also conduct detailed treatment fidelity and scalability assessments
(acceptability, feasibility, potential reach and adoption, alignment with the strategic
context) to inform a full-scale efficacy trial.
