Cigarette Smoking, Drug Use
Conditions
Keywords
Cigarette Smoking, Drug Use, Depressed Mood
Brief summary
The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. The approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.
Detailed description
This project will take place in two phases. In the first phase, the investigators will utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing Smokers (BA-DAS). In Phase II, the investigators will randomize 80 patients to either: 1) standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2) BA-DAS (which includes ST and NRT). Based on the outcome of this preliminary trial, the BA-DAS protocol will be further refined and readied for larger-scale clinical trials to develop a comprehensive approach to treating smoking among low income, largely minority, depressed smokers in residential drug use treatment, which may be instrumental in reducing smoking among this especially at risk group.
Interventions
BEHAVIORALStandard Treatment
Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
BEHAVIORALBAD-AS
The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
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. Participants in both intervention arms will receive transdermal nicotine patch.
Sponsors
American Cancer Society, Inc.
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 * regular smoker for at least one year * currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and Milds included) per day * report motivation to quit smoking in the next month * report elevated depressive symptoms
Exclusion criteria
* physical concerns contraindicating the nicotine patch * limited mental competency and/or the inability to give informed, voluntary, written consent to participate * current use of pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt * use of psychotropic medication for \< 3 months * primary use of other tobacco products (specifically: chewing tobacco, cigars, and pipes) * psychotic symptoms * current pregnancy or plans to become pregnant within the following three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date | 26 weeks post quit date | 7 days of smoking abstinence confirmed biochemically at 26 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Smoking Cessation Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
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. Participants in both intervention arms will receive transdermal nicotine patch. | 47 |
| BA for Substance Abusing Smokers The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
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. Participants in both intervention arms will receive transdermal nicotine patch. | 49 |
| Total | 96 |
Baseline characteristics
| Characteristic | BA for Substance Abusing Smokers | Total | Standard Smoking Cessation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 94 Participants | 45 Participants |
| Age, Continuous | 42.57 years STANDARD_DEVIATION 10.58 | 43.25 years STANDARD_DEVIATION 10.13 | 43.98 years STANDARD_DEVIATION 9.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 89 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment United States | 49 participants | 96 participants | 47 participants |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 33 Participants | 65 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 47 | 0 / 49 |
| other Total, other adverse events | 0 / 47 | 0 / 49 |
| serious Total, serious adverse events | 0 / 47 | 0 / 49 |
Outcome results
Primary
Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
7 days of smoking abstinence confirmed biochemically at 26 weeks
Time frame: 26 weeks post quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Smoking Cessation | Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date | 5 Participants |
| BA for Substance Abusing Smokers | Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date | 1 Participants |