Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21DA029445 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation for Smoking | Experimental | Eight 60-minute group sessions over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after treatment sessions have ended. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Nicotine Patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks post quit date |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion criteria only for the fMRI portion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura MacPherson, PhD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, College Park | College Park | Maryland | 20742 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation for Smoking |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population is not different from the assignment in Participant Flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 12 weeks post quit date |
|
|
Through study completion, an average of 20 weeks.
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Activation for Smoking |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura MacPherson | University of Maryland | 6198578425 | lauramac.phd@gmail.com |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
Not provided
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |