Smoking Cessation Clinical Trial
Official title:
Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Verified date | September 2021 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.
Status | Completed |
Enrollment | 122 |
Est. completion date | October 15, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Smoke 3-30 cigarettes/day - Desire to quit smoking as indicated on a smoking stages ladder - Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12 oz beer, 5 oz wine, 1.5 oz liquor) - Ability to understand, read, and write in English, at least 8th grade education - Willing and able to sign an informed consent - Stable residence and contact information. Exclusion Criteria: - Hepatic panel indices > 2 SD - History of seizures or DTs during alcohol withdrawal - Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations, severe depression, obsessional thinking, self-injury risking significant blood loss, etc.) deemed by the study physician to be at significant risk for adverse interactions with study medications or measures. - History of adverse reactions to varenicline (VAR) or nicotine patch - Current suicidal ideation (past 6 months) and/or history of major suicide attempts. - For women of child-bearing potential: currently pregnant, lactating, current plans to become pregnant in next three months, or unable to agree to adequate birth control during study participation. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Addictions Research Laboratory | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | Pfizer |
United States,
Coe JW, Brooks PR, Vetelino MG, Wirtz MC, Arnold EP, Huang J, Sands SB, Davis TI, Lebel LA, Fox CB, Shrikhande A, Heym JH, Schaeffer E, Rollema H, Lu Y, Mansbach RS, Chambers LK, Rovetti CC, Schulz DW, Tingley FD 3rd, O'Neill BT. Varenicline: an alpha4beta2 nicotinic receptor partial agonist for smoking cessation. J Med Chem. 2005 May 19;48(10):3474-7. — View Citation
Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. Erratum in: JAMA. 2006 Sep 20;296(11):1355. — View Citation
Koegelenberg CF, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O'Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen TM, Irusen EM. Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014 Jul;312(2):155-61. doi: 10.1001/jama.2014.7195. — View Citation
Perkins KA, Mercincavage M, Fonte CA, Lerman C. Varenicline's effects on acute smoking behavior and reward and their association with subsequent abstinence. Psychopharmacology (Berl). 2010 May;210(1):45-51. doi: 10.1007/s00213-010-1816-9. Epub 2010 Mar 20. — View Citation
Tapper AR, McKinney SL, Nashmi R, Schwarz J, Deshpande P, Labarca C, Whiteaker P, Marks MJ, Collins AC, Lester HA. Nicotine activation of alpha4* receptors: sufficient for reward, tolerance, and sensitization. Science. 2004 Nov 5;306(5698):1029-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline Smoking Abstinence Rates at 12 Weeks | Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports. | 12 weeks | |
Secondary | Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks | Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks | 12 weeks | |
Secondary | Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks | Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks | 26 weeks | |
Secondary | Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks | Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 12 weeks | 12 weeks | |
Secondary | Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks | Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 26 weeks | 26 weeks | |
Secondary | Change From Baseline Smoking Abstinence Rates at 26 Weeks | Number of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports. | 26 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT04617444 -
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
|
N/A | |
Completed |
NCT02796391 -
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
|
Phase 2 | |
Completed |
NCT03397511 -
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
|
N/A | |
Not yet recruiting |
NCT05188287 -
A Culturally Tailored Smartphone Application for African American Smokers
|
N/A | |
Recruiting |
NCT05264428 -
The Effect of Honey on Lessening the Withdrawal Symptoms
|
N/A | |
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT04133064 -
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
|
N/A | |
Completed |
NCT03187730 -
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
|
Phase 4 | |
Completed |
NCT03474783 -
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
|
N/A | |
Completed |
NCT04635358 -
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
|
N/A | |
Terminated |
NCT03670264 -
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
|
N/A | |
Not yet recruiting |
NCT06307496 -
VIDeOS for Smoking Cessation
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02997657 -
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Completed |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |