Smoking Clinical Trial
Official title:
Varenicline for Smoking Cessation in Heavy Drinking Smokers
Verified date | August 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Between the ages of 18 and 75. 2. Smoking 5 or more cigarettes per occasion at least 3 times per week. 3. Fewer than 3 months of smoking abstinence in the past year. 4. Motivated to stop smoking. 5. Report exceeding maximum weekly drinking limits every week in the past 4 weeks and exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks. Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion. Exclusion Criteria: 1. Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation 2. Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin) 3. Clinically significant cardiovascular disease 4. Uncontrolled hypertension 5. Hepatic or renal impairment 6. Severe chronic obstructive pulmonary disease 7. Diabetes mellitus requiring insulin or oral hypoglycemic medications. 8. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg 9. History of cancer (except treated basal cell or squamous cell carcinoma of the skin). 10. History of clinically significant allergic reactions. 11. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination) 12. Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol. 13. Have a current Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of > 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal. 14. Use of another investigational drug within 30 days. 15. Intention to donate blood or blood products during the treatment phase of the study. 16. Use of tobacco products other than cigarettes or use of marijuana. 17. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication. 18. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg. 19. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
Fucito LM, Toll BA, Wu R, Romano DM, Tek E, O'Malley SS. A preliminary investigation of varenicline for heavy drinking smokers. Psychopharmacology (Berl). 2011 Jun;215(4):655-63. doi: 10.1007/s00213-010-2160-9. Epub 2011 Jan 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. | Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions. | Last 4 weeks of treatment | |
Primary | Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions | Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period. | First 3 weeks (pretreatment) | |
Secondary | Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions | Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase | First 3 weeks (pretreatment) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02649556 -
A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2
|
N/A | |
Completed |
NCT03901066 -
Smoking Dependence and Periodontitis
|
||
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT03170752 -
Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)
|
N/A | |
Completed |
NCT03305978 -
Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.
|
N/A | |
Completed |
NCT00000437 -
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
|
Phase 4 | |
Completed |
NCT06105424 -
BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
|
N/A | |
Active, not recruiting |
NCT02752022 -
Monitoring the Transition From Smoking to E-cigarettes
|
||
Completed |
NCT02901171 -
The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation
|
N/A | |
Completed |
NCT04340830 -
The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02912000 -
TEACH: Technology Evaluation to Address Child Health
|
N/A | |
Completed |
NCT02949648 -
Electronic Cigarette Use and Quitting in Youth
|
N/A | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT02246114 -
Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women
|
N/A | |
Completed |
NCT01954407 -
Young Adults' Responses to Anti-smoking Messages
|
N/A | |
Completed |
NCT01898507 -
Nicotine Metabolism and Low Nicotine Cigarettes
|
N/A | |
Completed |
NCT02008292 -
Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors
|
N/A |