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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA030652 | 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 investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).
In this Stage I Behavioral & Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistence Targeted Smoking Cessation | Experimental | Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge |
|
| Clearing The Air | Active Comparator | Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persistence Targeted Smoking Cessation | Behavioral | 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Abstinence | 3-months after the Quit Date | 3-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc L Steinberg, Ph.D. | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Persistence Targeted Smoking Cessation | Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") Nicotine lozenge: 12-weeks 4mg nicotine lozenge |
| FG001 | Clearing The Air | Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air Nicotine lozenge: 12-weeks 4mg nicotine lozenge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Persistence Targeted Smoking Cessation | Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") Nicotine lozenge: 12-weeks 4mg nicotine lozenge |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 7-day Point Prevalence Abstinence | 3-months after the Quit Date | Posted | Number | participants | 3-months |
|
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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 | Persistence Targeted Smoking Cessation | Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") Nicotine lozenge: 12-weeks 4mg nicotine lozenge |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc L. Steinberg, Ph.D. | Rutgers Robert Wood Johnson Medical School | 7322354341 | marc.steinberg@rutgers.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Clearing The Air | Behavioral | 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air |
|
|
| Nicotine lozenge | Drug | 12-weeks 4mg nicotine lozenge |
|
| Clearing The Air |
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air Nicotine lozenge: 12-weeks 4mg nicotine lozenge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 28 |
| 19 |
| 28 |
| EG001 | Clearing The Air | Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air Nicotine lozenge: 12-weeks 4mg nicotine lozenge | 0 | 30 | 13 | 30 |
| Throat irritation | General disorders |
|
| Upset stomach | Gastrointestinal disorders |
|
| Insomnia | Psychiatric disorders |
|
| Heartburn | Gastrointestinal disorders |
|
| Hiccups | General disorders |
|
| Coughing | General disorders |
|
| Sore throat | General disorders |
|
| Dizziness | Nervous system disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Cold symptoms | Immune system disorders |
|
| Decreased appetite | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Nasal congestion | Immune system disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Migraine | Nervous system disorders |
|
| Tooth ache | General disorders |
|
| Irregular Bowel Movement | Gastrointestinal disorders |
|
| Heart flutter | Cardiac disorders |
|
| Headache | Nervous system disorders |
|
| Sweating | General disorders |
|
| Nose flaring | General disorders |
|
| Burning sensation in cheek area | General disorders |
|
| Sore gums | General disorders |
|
| Canker sore | General disorders |
|
| Gas | Gastrointestinal disorders |
|
| Fibromyalgia pain worsening | Nervous system disorders |
|
| Irritability | Psychiatric disorders |
|
| Poor concentration/forgetfulness | Psychiatric disorders |
|
| Increased appetite | Gastrointestinal disorders |
|
| Burning pepper taste | General disorders |
|
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| D001519 | Behavior |