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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA026511-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.
Participants in this study are randomized to one of two treatments conditions prior to a target quit date.
All participants are asked to attend a 2-hour orientation session, complete 8 brief (5-minute) telephone calls and 9 longer(20-minute) telephone surveys over 3.5 weeks, attend a 30-minute office visit, and complete two 15-minute follow-up calls.
All participants are also asked to report on their emotions, thoughts, and behaviors 3 times per day for 24 days using cellular telephones.
Participants receive compensation for office visits, study telephone calls, cellular telephone reports, and follow-up interviews.
All participants will receive nicotine patches and one-on-one counseling (delivered over the phone and in person).
Some participants will be eligible for a second phase of treatment after a 4-week follow-up interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator | In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking |
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| Standard treatment+practice quitting | Experimental | In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling. |
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| Very low nicotine cigarettes | Experimental | In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this group. Those assigned to this group will receive a 6-week supply of cigarettes that contain tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment is designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking |
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| Advice and encouragement only | No Intervention | In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this condition. Those in this arm will receive advice and encouragement to try to stop smoking again after they have slipped (returned to smoking) during a stop smoking attempt. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment | Behavioral | Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking |
| Measure | Description | Time Frame |
|---|---|---|
| 4-week Abstinence | 7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 10-week Abstinence | This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle E McCarthy, Ph.D. | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University Institute for Health, Health Care Policy, and Aging Research | New Brunswick | New Jersey | 08901 | United States |
Randomization was in 2 phases; 1: participants who met inclusion/exclusion criteria were randomized to either standard treatment or standard treatment plus practice quitting; in phase 2, smokers who smoked between weeks 3 and 4 post-quit were randomly assigned to either receive advice only, or advice plus very low nicotine cigarettes.
Recruitment occurred between June 12, 2012 and May 24, 2013 through community-wide recruitment including direct mail, flyers, and radio advertising.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking |
| FG001 | Standard Treatment+Practice Quitting | In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling. Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The total number of participants in the sample was 93. The 40 participants randomly assigned to Very low nicotine cigarettes or Advice and encouragement only were a subset of the 93 participants randomly assigned to initial experimental conditions (Standard treatment or Standard treatment+practice quitting) if still smoking at 4-week follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking |
| 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, 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 | 4-week Abstinence | 7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt). | Posted | Number | participants | 4 weeks |
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All participants were asked to report any changes in their health at every live assessment contact with them following the initiation of treatment (a total of 19 contacts over the course of 12 weeks).
Assessment was systematic in that all researchers were trained to provide a standardized prompt "Have you noticed any changes in your health since we last spoke with you?" at every live assessment call or visit during the study.
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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 | Standard Treatment | In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth abscess | Infections and infestations | Systematic Assessment | Tooth abscess requiring emergency surgery and overnight hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory infection, congestion, or illness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Symptoms of nasal or sinus congestion, sore throat, asthma (in previously diagnosed individuals), and mild shortness of breath. |
The sample comprised adult treatment-seeking smokers who met inclusion criteria and were willing to participate in a randomized controlled trial involving intensive assessment and offering substantial compensation.
The degree to which results will generalize to medically or mentally ill smokers is unknown.
Neither participants nor researchers were blind to condition assignment. All abstinence outcomes were based on self-report rather than biochemical verification.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle E. McCarthy, Ph.D. | Rutgers, The State University of New Jersey | 608-265-5949 | demccarthy@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2013 | Mar 30, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Standard treatment+practice quitting | Behavioral | This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling |
|
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| Very low nicotine cigarettes | Drug | This intervention will be offered to a subset of smokers from both of the other study arms. To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above. Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks. |
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| Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date | Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident. | 3 weeks pre-quit |
| Prolonged Abstinence | This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt. | 10 weeks |
| BG001 |
| Standard Treatment+Practice Quitting |
In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling. Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| 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 |
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In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
|
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| Secondary | 10-week Abstinence | This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million. | Posted | Number | participants | 10 weeks |
|
|
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| Secondary | Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date | Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident. | Participants who quit for at least 1 day in the first 2 weeks after the target quit date. | Posted | Mean | Standard Error | units on a scale | 3 weeks pre-quit |
|
|
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| Secondary | Prolonged Abstinence | This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt. | Posted | Number | participants | 10 weeks |
|
|
|
| 3 |
| 47 |
| 29 |
| 47 |
| EG001 | Standard Treatment+Practice Quitting | In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling. Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling | 4 | 46 | 22 | 46 |
| EG002 | Very Low Nicotine Cigarettes | Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks. | 2 | 20 | 10 | 20 |
| EG003 | Advice and Encouragement Only | Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt. | 1 | 20 | 13 | 20 |
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| Upper GI tract disorder | Gastrointestinal disorders | Systematic Assessment | Participant reported that he was hospitalized for severe upper gastrointestinal tract problems, had an endoscopy, and was prescribed new medication. Participant was not on study medication at the time of his symptoms or hospitalization. |
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| Broken toe | Injury, poisoning and procedural complications | Systematic Assessment | Participant reported an injury that broke a toe and said that she was hospitalized overnight for observation. Participant reported using study medication (nicotine patch) at the time of the injury. |
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| Chest pain | Gastrointestinal disorders | Systematic Assessment | Participant reported experiencing chest pain; she went to an emergency dept., had an ECG, and cardiac catheterization before leaving with a negative diagnosis for cardiac disorder. She was given esomeprazole and sucralfate and an endoscopy order. |
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| Leg and back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participant reported leg and back pain worsening over three months that prompted an emergency dept. visit and hospitalization for MRI and plethysmography; left with pain medication. |
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| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment | Participant experienced nausea, vomiting, abdominal pain; was admitted to hospital, diagnosed with a bowel obstruction, treated, and released after 5 days. |
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| Respiratory distress, diabetes, and dehydration | General disorders | Systematic Assessment | At follow-up, participant reported 4 emergency dept. visits and hospitalization for varied symptoms (cough, chills, nausea, abdominal pain, headache) and said she was treated for dehydration, had her insulin for DM-II adjusted, and had a procedure. |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Cough, whether dry or productive, is presented separately from other respiratory symptoms due to its potential relation to quitting smoking. |
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| Sleep disturbance | Psychiatric disorders | Systematic Assessment | Mild sleep disturbance (difficulty falling asleep, vivid dreams, waking in the night). |
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| Gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment | Heartburn, nausea, abdominal pain or cramping. |
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| Headache | General disorders | Systematic Assessment | Headaches, including migraine headaches. |
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| Skin irritation, rash, or pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Transdermal nicotine patches were provided to all participants and skin irritation, redness, rash, or discomfort at the patch site was reported by some participants. |
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| Dizziness or lightheadedness | General disorders | Systematic Assessment | Feeling dizzy, lightheaded, or faint. |
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| Fatigue | General disorders | Systematic Assessment | Tiredness, fatigue, sleepiness. |
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| D015438 |
| Health Behavior |
| Smoking (any cigarettes in past 7 days) |
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| Lost to 10-week follow-up |
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| Smoking (7 days in a row) |
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| Lost to 10-week follow-up |
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