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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA038442 | 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 goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRT | Placebo Comparator |
| |
| VAR | Placebo Comparator |
| |
| PLAC | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Craving Score During Cue Exposure Task | Scores range from 0 (no craving) to 100 (extreme craving). | Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3) |
| Change in Latency to Smoke During Cue Exposure Task | The latency is the interval between smoking one cigarette and wanting, craving, or needing another. | Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3) |
| Change in Smoke Intake During Cue Exposure Task | Measured by number of puffs. | Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis J McClernon, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Center | Durham | North Carolina | 27705 | United States |
37 participants were withdrawn from the study prior to treatment assignment due to either loss of interest, lost to contact, or inability to complete baseline procedures per protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (PLAC) | Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. |
| FG001 | Transdermal Nicotine Patch (NRT) | Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the NRT group, participants will take a placebo capsule while wearing nicotine patches. |
| FG002 | Varenicline (VAR) | Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions. In the VAR group, participants will wear a placebo patch while taking varenicline. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (PLAC) | Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in Craving Score During Cue Exposure Task | Scores range from 0 (no craving) to 100 (extreme craving). | Subjects who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3) |
|
3 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 | Placebo (PLAC) | Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial blood infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony DeVito, MD | Duke University | 919-684-1377 | anthony.devito@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2017 | Dec 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
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| Varenicline | Drug | Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions. |
|
|
| Placebo Nicotine Patch | Drug | In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. In the VAR group, participants will wear a placebo patch while taking varenicline. |
|
| Placebo Capsule | Drug | In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. In the NRT group, participants will take a placebo capsule while wearing nicotine patches. |
|
| BG001 | Transdermal Nicotine Patch (NRT) | Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the NRT group, participants will take a placebo capsule while wearing nicotine patches. |
| BG002 | Varenicline (VAR) | Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions. In the VAR group, participants will wear a placebo patch while taking varenicline. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Transdermal Nicotine Patch (NRT) | Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the NRT group, participants will take a placebo capsule while wearing nicotine patches. |
| OG002 | Varenicline (VAR) | Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions. In the VAR group, participants will wear a placebo patch while taking varenicline. |
|
|
|
| Primary | Change in Latency to Smoke During Cue Exposure Task | The latency is the interval between smoking one cigarette and wanting, craving, or needing another. | Subjects who completed the study. | Posted | Mean | Standard Deviation | seconds | Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3) |
|
|
|
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| Primary | Change in Smoke Intake During Cue Exposure Task | Measured by number of puffs. | Subjects who completed the study. | Posted | Mean | Standard Deviation | puffs | Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3) |
|
|
|
|
| 0 |
| 31 |
| 2 |
| 31 |
| 0 |
| 31 |
| EG001 | Transdermal Nicotine Patch (NRT) | Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. In the NRT group, participants will take a placebo capsule while wearing nicotine patches. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Varenicline (VAR) | Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions. In the VAR group, participants will wear a placebo patch while taking varenicline. | 0 | 30 | 0 | 30 | 0 | 30 |
| Blood in urine | Renal and urinary disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | Non-systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011810 | Quinoxalines |