Smoking
Conditions
Keywords
Behavioral Activation
Brief summary
The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.
Detailed description
1. 18-21 years of age, 2. a regular smoker for at least 6 months 3. currently smoking an average of at least 5 cigarettes per day 4. want to quit smoking 5. report current elevated depressive symptoms
Interventions
DRUGTransdermal Nicotine Patch
Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch 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 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* between 18 and 21 years of age * a regular smoker for at least 6 months * currently smoking an average of at least 5 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 * limited mental competency \[Mini Mental State Examination score \< 23\] and/or the inability to give informed, voluntary, written consent to participate * current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date | 12 weeks post quit date | 7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Activation for Smoking Behavioral Activation for Smoking (BATSY) includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Participants will also be provided 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 participant's initial nicotine level. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Behavioral Activation for Smoking |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 20.00 years STANDARD_DEVIATION 1.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date
7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks
Time frame: 12 weeks post quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Activation for Smoking | Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date | 7 Participants |