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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017332 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Smoking Cessation Counseling | Experimental |
|
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| Standard Smoking Cessation Counseling | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Nicotine | Drug | Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biochemically Verified Smoking Abstinence |
| Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Brown, PhD | Butler Hospital/Brown Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Distress Tolerance Cessation Counseling | One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. 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: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
| FG001 | Standard Smoking Cessation Counseling | One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. 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: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population is not different from the assignment in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | New Smoking Cessation Counseling |
Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The measure is a count of the number of participants enrolled in the study at baseline. |
| 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 With Biochemically Verified Smoking Abstinence |
| Posted | Count of Participants | Participants | Six months |
|
3 years, 6 months
Definition of adverse event and/or serious adverse event does not differ from clinicaltrials.gov definitions. There were no adverse events reported during the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Distress Tolerance Cessation Counseling | One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. 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: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard A. Brown | University of Texas at Austin | 512-471-8584 | brown2@utexas.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000073865 | Cigarette Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| BG001 | Standard Smoking Cessation Counseling |
Transdermal Nicotine: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Standard Smoking Cessation Counseling |
One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. 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: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. |
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Standard Smoking Cessation Counseling | One 60-minute individual session Seven 2-hour group sessions Two individual brief telephone contacts over an eight-week period. 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: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 | Health Behavior |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |