Cigarette Smoking
Conditions
Keywords
Smoking, Smoking Cessation
Brief summary
Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of cognitive-behavioral treatment for individuals with a history of major depressive disorder (MDD) in standard cessation treatment. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms to address their association with cessation failure. Thus the objective of the present proposal is to conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation intervention to standard treatment among a similar community sample of 200 adult smokers with elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analysis of cessation outcomes.
Detailed description
This will be a Stage II randomized control trial to examine the efficacy of behavioral activation treatment for smoking (BATS) vs. standard smoking cessation treatment (ST). We will recruit 200 smokers with elevated depressive symptoms who will be randomized into one of two treatment groups. Treatment will be delivered in group format across both the BATS (n = 100) and ST condition (n = 100). All participants will receive 8 weeks of transdermal nicotine patch in addition to their assigned treatment group. We intend to compare the BA treatment for smoking (BATS) to a standard smoking cessation intervention (ST)on abstinence and relapse outcomes. In addition we will examine to what extent depressive symptoms and reward sensitivity prior to quit date will mediate the effects of BATS on improved smoking cessation outcomes relative to ST.
Interventions
BEHAVIORALStandard Treatment
Participants will receive a standard, group smoking cessation treatment, based on the most recent clinical practice guideline for treating tobacco use from the U.S. Department of Health and Human Services. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events as a means to equate for time spent on daily activity monitoring in the BATS condition.
BEHAVIORALBehavioral Activation Treatment for Smoking
BATS is focused on identifying life areas, values, and daily activities to help one live according to his or her values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period.
DRUGTransdermal Nicotine Patch
8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
University of Maryland, College Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 65 years of age * A regular smoker for at least one year * Currently smoking an average of at least 10 cigarettes per day * Want to quit smoking * Report current elevated depressive symptoms
Exclusion criteria
* Current Axis I disorder * Psychoactive substance dependence (excluding nicotine dependence) within the past 6 months * Current use of psychotropic medication or participation in any form of psychotherapy * A history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness * Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date | 52 weeks post quit date | 7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment (ST) Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. | 88 |
| Behavioral Activation for Smoking Behavioral Activation Treatment for Smoking (BATS) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Eight, 60-minute group sessions over an 8-week period. Participants will also receive 8 weeks of the transdermal nicotine patch.
Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Transdermal Nicotine Patch: 8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. | 96 |
| Total | 184 |
Baseline characteristics
| Characteristic | Behavioral Activation for Smoking | Total | Standard Treatment (ST) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 183 Participants | 87 Participants |
| Age, Continuous | 44.02 years STANDARD_DEVIATION 12.47 | 44.61 years STANDARD_DEVIATION 11.51 | 45.25 years STANDARD_DEVIATION 10.38 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 74 Participants | 139 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) White | 12 Participants | 21 Participants | 9 Participants |
| Region of Enrollment United States | 96 participants | 184 participants | 88 participants |
| Sex: Female, Male Female | 39 Participants | 82 Participants | 43 Participants |
| Sex: Female, Male Male | 57 Participants | 102 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 88 | 0 / 96 |
| other Total, other adverse events | 0 / 88 | 0 / 96 |
| serious Total, serious adverse events | 2 / 88 | 1 / 96 |
Outcome results
Primary
Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date
7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt
Time frame: 52 weeks post quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment (ST) | Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date | 26 Participants |
| Behavioral Activation for Smoking | Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date | 19 Participants |