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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA025598 | 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 purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.
The following primary hypothesis will be tested:
Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.
Other hypotheses include:
Cigarette smokers will be randomized to:
Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLNC Cigarette | Active Comparator | Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. |
|
| Nicotine Patch | Active Comparator | 21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. |
|
| VLNC Cigarette plus Nicotine Patch | Experimental | Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | 21 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| End of Treatment Abstinence Rate | Cotinine and carbon monoxide (CO) verified point prevalence abstinence | 12 week |
| End of Follow-up Abstinence Rates | CO- and cotinine-verified point prevalence abstinence | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to Tobacco Toxicants | 6 weeks | |
| Time to Lapse or Relapse to Tobacco Use | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Hatsukami, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Duluth | Minnesota | 55812 | United States | ||
| University of MN's Tobacco Use Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23603206 | Result | Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19. | |
| 25192771 | Derived | Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 5. |
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After signing consent and before randomization to groups, 44 were lost to follow-up, 17 were ineligible, 10 were no longer interested, 10 were family members of enrollees.
Oct 2008 to September 2011 Location was at the University of Minnesota Twin Cities and Duluth, Minnesota
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| ID | Title | Description |
|---|---|---|
| FG000 | VLNC Cigarette | Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks. |
| FG001 | VLNC Cigarette Plus Nicotine Patch | Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks. |
| FG002 | Nicotine Patch | Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VLNC Cigarette | Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield. |
| BG001 | VLNC Cigarette Plus Nicotine Patch | VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. |
| 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 | End of Treatment Abstinence Rate | Cotinine and carbon monoxide (CO) verified point prevalence abstinence | Posted | Number | participants | 12 week |
|
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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 | VLNC Cigarette | Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | General disorders | MedDRA (10.0) | Systematic Assessment |
Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dorothy Hatsukami | University of Minnesota | 612 626-2121 | hatsu001@umn.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 |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| VLNC Cigarette | Other | Cigarette where the tobacco contains <0.1 mg of nicotine yield. |
|
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| VLNC Cigarette Plus Nicotine Patch | Other | 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. |
|
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| Minneapolis |
| Minnesota |
| 55414 |
| United States |
| Lack of Efficacy |
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| Adverse Event |
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| Physician Decision |
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| BG002 | Nicotine Patch | 21 mg nicotine patch |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
21 mg nicotine patch
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| Primary | End of Follow-up Abstinence Rates | CO- and cotinine-verified point prevalence abstinence | Posted | Number | participants | 36 weeks |
|
|
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| Secondary | Exposure to Tobacco Toxicants | Posted | Geometric Mean | 95% Confidence Interval | pmol/mg creatinine | 6 weeks |
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|
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| Secondary | Time to Lapse or Relapse to Tobacco Use | Posted | Median | 95% Confidence Interval | weeks | 26 weeks |
|
|
|
| 0 |
| 79 |
| 60 |
| 79 |
| EG001 | VLNC Cigarette Plus Nicotine Patch | VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. | 0 | 76 | 56 | 76 |
| EG002 | Nicotine Patch | 21 mg nicotine patch | 0 | 80 | 54 | 80 |
| Headaches | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
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| Lightheadedness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Stomach Ache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Shakiness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Belching | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Sore Throat | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Sleep Disturbance | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Muscle Aches | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| D001519 | Behavior |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Total Nicotine Exposure (TNE) |
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| Cotinine |
|