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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Active Comparator |
| |
| placebo pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Reduction | 50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced. | At 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc L Steinberg, Ph.D. | University of Medicine and Dentistry of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Addiction Psychiatry | New Brunswick | New Jersey | 08901 | United States |
73 potential participants provided informed consent and were therefore "Enrolled," however 10 of these did not meet all eligibility criteria as they were completing the baseline measures. We therefore "Started" 63 randomized participants as indicated in the Participant Flow module.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter. |
| FG001 | Placebo Pill | Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter. |
| BG001 | Placebo Pill |
| 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 | Cigarette Reduction | 50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced. | Posted | Number | participants | At 6-month follow-up |
|
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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 | Varenicline | Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc Steinberg | Rutgers Robert Wood Johnson Medical School | 7322354341 | marc.steinberg@rutgers.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo pill | Drug | Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter. |
|
Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 31 |
| 17 |
| 31 |
| EG001 | Placebo Pill | Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter. | 0 | 32 | 16 | 32 |
| Vivid or Bizarre Dreams | General disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Irritability | General disorders |
|
| Restlessness | General disorders |
|
| Upset stomach | Gastrointestinal disorders |
|
| Headache | General disorders |
|
| Dizzy/light-headed | General disorders |
|
| Insomnia or fitful sleep | General disorders |
|
| Sexual dysfunction | General disorders |
|
| Abdominal cramps | Gastrointestinal disorders |
|
| Toothache | General disorders |
|
| Congestion | General disorders |
|
| Increased depressive symptoms | Psychiatric disorders |
|
| Fatigue | General disorders |
|
| Cold/Flu symptoms | General disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Increased appetite | General disorders |
|
| Blunted affect | Psychiatric disorders |
|
| Itchy | General disorders |
|
| Hot flashes | Endocrine disorders |
|
| Chest twitches | Cardiac disorders |
|
| Pulled muscle in back | General disorders |
|
| Gas | Gastrointestinal disorders |
|
| Strained bowel movement | Gastrointestinal disorders |
|
| Dry mouth | General disorders |
|
| Nose bleed | General disorders |
|
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| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D011810 | Quinoxalines |