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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA129226 | U.S. NIH Grant/Contract | View source | |
| BUTLER-0807-004 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.
At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.
Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).
NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.
PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. |
|
| Arm II | Placebo Comparator | Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. |
|
| Arm III | Active Comparator | Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine | Drug | Given transdermally and orally |
| |
| varenicline |
| Measure | Description | Time Frame |
|---|---|---|
| Self- Reported 7-day Abstinence | Number of participants with self-reported, 7-day abstinence at 6-months | 6 Months |
| Carbon Monoxide (CO)-Confirmed 7-day Abstinence | Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement. | 6-Months |
| Rates of Smoking Cessation Continuous From First Quit Day to 6 Months | Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months | 6-Months |
| Self-reported 7-day Abstinence | Number of participants with self-reported 7-day abstinence at 12-months | 12 Months |
| CO-confirmed 7-day Abstinence | Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Smoking Urges | Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score. | 6 months |
| Withdrawal Symptoms |
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INCLUSION CRITERIA
Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
Interested in quitting smoking
Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
Has received methadone for at least the past month
EXCLUSION CRITERIA
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Stein, MD | Butler Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23953658 | Background | Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14. | |
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally |
| FG001 | Arm II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| End of Treatment (6 Month Interview) |
|
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| Drug |
Given orally |
|
| placebo | Other | Given orally |
|
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score. |
| 6 months |
| Retention in Methadone Maintenance | 12 months |
| Methadone Dose Changes | 12 months |
| Use of Illicit Drugs as Measured by Urine Toxicologies | 12 months |
| Reinforcing Effects of Smoking | Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score. | 6 months |
| Change in Cigarettes Per Day | Change in mean cigarettes per day | 6-Months |
| 24821357 | Derived | de Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764. |
| 23199641 | Derived | Caviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28. |
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
| FG002 | Arm III | Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| End of Study (12 Month Interview) |
|
|
All eligible participants who completed enrollment and were randomized were included in baseline analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally |
| BG001 | Arm II | Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally |
| BG002 | Arm III | Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Years of Education | Mean | Standard Deviation | years |
|
| 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 | Self- Reported 7-day Abstinence | Number of participants with self-reported, 7-day abstinence at 6-months | Posted | Number | participants | 6 Months |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Carbon Monoxide (CO)-Confirmed 7-day Abstinence | Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement. | Posted | Number | participants | 6-Months |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Rates of Smoking Cessation Continuous From First Quit Day to 6 Months | Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months | Posted | Number | participants | 6-Months |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Self-reported 7-day Abstinence | Number of participants with self-reported 7-day abstinence at 12-months | Posted | Number | participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||
| Primary | CO-confirmed 7-day Abstinence | Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement. | Posted | Number | participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Smoking Urges | Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Withdrawal Symptoms | Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Retention in Methadone Maintenance | Data not collected | Posted | 12 months |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Methadone Dose Changes | Data not collected | Posted | 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Use of Illicit Drugs as Measured by Urine Toxicologies | Data not collected | Posted | 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Reinforcing Effects of Smoking | Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Cigarettes Per Day | Change in mean cigarettes per day | Posted | Mean | Standard Deviation | cigarettes/day | 6-Months |
|
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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 | Arm I | Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally | 4 | 137 | 0 | 137 | ||
| EG001 | Arm II | Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally | 2 | 45 | 0 | 45 | ||
| EG002 | Arm III | Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally | 2 | 133 | 0 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurobehavioral Adverse Effects | Psychiatric disorders | Participant described hearing voices |
| ||
| Neurobehavioral Adverse Events | Psychiatric disorders | Participant reported mood disturbance |
| ||
| Participant Death | General disorders | Participant died during study participation |
| ||
| Heart Attack | Cardiac disorders | Participant was hospitalized with symptoms of heat attack |
| ||
| Skin Rash | Skin and subcutaneous tissue disorders | Participants complained of skin rashes |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Stein | Butler Hospital | 401-455-6646 | michael_stein@brown.ed |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D014029 | Tobacco Use Disorder |
| D002292 | Carcinoma, Renal Cell |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007674 | Kidney Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011810 | Quinoxalines |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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