Smoking Cessation Clinical Trial
Official title:
CSP #725 - Mood and Smoking: A Comparison of Smoking Cessation Treatments
Objectives:
The long term objectives of this research program are:
1. To advance the mission of the VHA Boston Healthcare System to deliver comprehensive
quality healthcare that meets the needs of patients (in this case, who have been
unresponsive to standard smoking cessation treatment) through research and clinical
care.
2. To expand upon our knowledge of the feasibility and effectiveness of commonly-used
treatments for nicotine dependence.
3. To further explore variables related to mood and coping that may contribute to or
prevent successful reduction and cessation of smoking behavior among veterans.
The short-term objectives of this project are:
1. To evaluate the feasibility and effectiveness of two adjunctive treatments (a
mood-focused exposure-based treatment, Mood Tolerance, with Nicotine Replacement
Therapy [MTNRT] and mood-focused affect-management treatment, Mood Management, with
Nicotine Replacement Therapy [MMNRT]) aimed at reduction and cessation of smoking
behavior among veterans who were previously non-responders to smoking cessation
treatment in the VA.
2. To inform equivocal findings in the literature regarding the role of mood as trigger
for smoking behavior.
3. To explore selected mood, coping, and individual difference variable that may be
predictive of successful abstinence from cigarettes among veterans.
Objectives:
The short-term objectives of this project are:
1. To evaluate the effectiveness of two adjunctive treatments (mood-focused exposure-based
treatment, Mood Tolerance, with Nicotine Replacement Therapy [MT-NRT] and mood-focused
affect-management treatment, Mood Management, with NRT [MM-NRT] aimed at reduction and
cessation of smoking behavior among veterans who were previously non-responders to
smoking cessation treatment.
2. To examine specific variables that may serve as mechanisms of action for successful
treatment (i.e., mood and coping variables).
The long-term objectives of this research program are:
1. To advance the mission of the VA to deliver comprehensive quality healthcare that meets
the needs of patients who have been unresponsive to standard smoking cessation
treatment, through research and clinical care.
2. To reduce the exorbitant healthcare costs of nicotine dependence (ND) to the VA, and to
improve veterans' physical and psychological well-being, healthcare utilization, and
mortality rates.
3. To evaluate effectiveness of common treatments for ND.
4. To explore mechanisms of action related to efficacy of treatment for ND among veterans
(i.e., changes in mood and coping.)
Research Design:
This is a two-cell, single-blind, randomized, treatment outcome study.
Methodology:
One hundred and twenty-eight smoking outpatients who have previously participated in
standard group smoking cessation treatment (treatment non-responders, with NRT) will be
recruited through the VA Boston Outpatient Health Psychology Clinic. Advertising flyers
posted throughout the Boston VA Medical Center and Outpatient Clinic will be used to
supplement this recruitment.
Baseline Assessment:
Interested and eligible patients will sign an informed consent form, which will be
thoroughly reviewed with each participant and co-signed by the investigators. Baseline
evaluation of the participants will take approximately 90 minutes. This evaluation will
include assessment of smoking-related variables, moods, and affect-regulation and coping
strategies, as well as carbon monoxide (CO) levels in expired breath.
Treatment:
Participants will be randomly assigned to one of the two treatments. This will involve
meeting with a pharmacist, primary care physician, psychiatrist, or nurse practitioner to be
screened for use of nicotine replacement therapy (NRT; transdermal patch) and to initiate
NRT use. A member of the research team will continue to monitor the participant's physical
health during the course of the treatment. In addition, the participant will attend
treatment groups once a week for 15 weeks. These treatment groups will be conducted by a
member of the research team or clinical students supervised by the PI. Each of these groups
will last 90 minutes.
Follow-Up:
The first follow-up appointment will take place in the week after completion of the
treatment. Additional follow-up assessments will take place at 3-, 6-, 9-, and 12-months
subsequent to the first follow-up appointment. These assessments will be almost identical to
the baseline assessment, and will last approximately 90 minutes.
Findings:
Thirty-four participants have been enrolled in this study; 12 of whom are currently actively
involved in the protocol. No data have been analyzed or presented yet.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind
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