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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009241-17 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Nicotine Patch and Contingency Management | Active Comparator | Subjects in this group will receive Contingency Management and active nicotine patch |
|
| Nicotine Patch with no Contingency Management | Active Comparator | Subjects in this group will receive active nicotine patch without contingency management for abstinence |
|
| Placebo patch and Contingency Management | Placebo Comparator | Subjects in this group will receive a placebo transdermal patch and contingency management |
|
| Placebo Patch and no Contingency Management | Placebo Comparator | Subjects in this group will receive a placebo patch and will not receive contingency management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy | Behavioral | Weekly CBT for all subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence Rates at the End of Treatment | Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence During Treatment | We will also examine continuous abstinence during the six week treatment period by urine analysis each week. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Nicotine Patch and Contingency Management | Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day |
| FG001 | Nicotine Patch With no Contingency Management | Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day |
| FG002 | Placebo Patch and Contingency Management | Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis |
| FG003 | Placebo Patch and no Contingency Management | Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Nicotine Patch and Contingency Management | Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day |
| 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 | Abstinence Rates at the End of Treatment | Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis. | Posted | Number | percentage of participants not smoking | 6 weeks |
|
Adverse events were collected at baseline through duration of treatment-6 weeks
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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 | Active Nicotine Patch and Contingency Management | Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Cavallo, Assistant Professor | Yale University | 2039747607 | dana.cavallo@yale.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
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| Contingency Management | Behavioral | incentives given for abstinence based on urine analysis |
|
| Nicotine Transdermal Patch | Drug | 14mg ir 21mg doses based on weight and #cigs/day |
|
|
| BG001 |
| Nicotine Patch With no Contingency Management |
Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day |
| BG002 | Placebo Patch and Contingency Management | Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis |
| BG003 | Placebo Patch and no Contingency Management | Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects in this group will receive active nicotine patch without contingency management for abstinence
Cognitive Behavioural Therapy: Weekly CBT for all subjects
Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day
| OG002 | Placebo Patch and Contingency Management | Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis |
| OG003 | Placebo Patch and no Contingency Management | Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects |
|
|
| Secondary | Continuous Abstinence During Treatment | We will also examine continuous abstinence during the six week treatment period by urine analysis each week. | this is the intent to treat group-all starters (not treatment completers) | Posted | Mean | Standard Deviation | consecutive days of abstinence | 6 weeks |
|
|
|
| 0 |
| 36 |
| 32 |
| 36 |
| EG001 | Nicotine Patch With no Contingency Management | Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day | 0 | 37 | 33 | 37 |
| EG002 | Placebo Patch and Contingency Management | Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis | 0 | 44 | 42 | 44 |
| EG003 | Placebo Patch and no Contingency Management | Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects | 0 | 37 | 33 | 37 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Change in appetite | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Blurred vision | Eye disorders | Non-systematic Assessment |
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| Rapid Heartbeat | Cardiac disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Nervousness | Social circumstances | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
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| Sleepiness | General disorders | Non-systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| VIvid Dreams | Psychiatric disorders | Non-systematic Assessment |
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| Sweating | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D012991 |
| Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |