Nicotine DependencePhase 2NCT00860028
Varenicline for Smoking Cessation in Heavy Drinking Smokers
A Phase 2 study testing Extended Varenicline Pretreatment and Short-term Varenicline Pretreatment in people with Nicotine Dependence and Smoking, run by Yale University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nicotine Dependence, Smoking, Heavy Drinking
- What is being tested?
- Extended Varenicline Pretreatment and Short-term Varenicline Pretreatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 75.
- Smoking 5 or more cigarettes per occasion at least 3 times per week.
- Fewer than 3 months of smoking abstinence in the past year.
- Motivated to stop smoking.
- 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.
Who cannot join
- Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
- Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
- Clinically significant cardiovascular disease
- Uncontrolled hypertension
- Hepatic or renal impairment
- Severe chronic obstructive pulmonary disease
Show all 19Show fewer
- Diabetes mellitus requiring insulin or oral hypoglycemic medications.
- Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
- History of cancer (except treated basal cell or squamous cell carcinoma of the skin).
- History of clinically significant allergic reactions.
- 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)
- Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol.
- 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.
- Use of another investigational drug within 30 days.
- Intention to donate blood or blood products during the treatment phase of the study.
- Use of tobacco products other than cigarettes or use of marijuana.
- 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.
- 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.
- 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).
About this study
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.
Read the detailed description
Smoking rates are elevated among drinkers compared to non-drinkers (Marks et al., 1997). Moreover, there is some evidence that both smokers who drink alcohol are less successful quitting smoking (Leeman, Huffman, \& O'Malley, 2007). Thus, identifying interventions that are effective in reducing both smoking and heavy drinking in this population is warranted. Varenicline, a medication recently approved by the FDA, results in smoking cessation rates as high as 50%, significantly better than bupropion or placebo. There is preliminary experimental evidence from both animal and human laboratory research that varenicline reduces alcohol seeking and consumption (McKee, 2008; Steensland et al., 2007).
The typical dose schedule for varenicline involves a 1 week pretreatment phase prior to quitting smoking (Gonzales et al., 2006; Jorenby et al., 2006; Nides et al., 2006). However, greater quit rates have been observed 1 month after using varenicline compared to 1 week. Therefore, it is possible that extended pretreatment with varenicline may also yield better cessation outcomes than the standard 1 week lead in period. This may be particularly true if pretreatment also reduces alcohol consumption prior to the quit attempt.
Thirty regular smokers who drink alcohol heavily will receive open-label varenicline for 5 weeks according to the recommended titration schedule up to 1mg varenicline twice daily. Prior to the smoking quit date, subjects will be randomized to receive either extended pretreatment with varenicline (titration up to 1mg) for 4 weeks or short-term varenicline pretreatment (3 weeks placebo followed by 1 week of varenicline).
The primary aims of the study are to examine: (a) the efficacy of extended varenicline pretreatment for smoking cessation, (b) the safety and tolerability of varenicline in heavy drinking smokers, and (c) the efficacy of varenicline for reducing alcohol consumption in human participants. Effect size estimates for prolonged smoking abstinence and heavy drinking will be generated for a NIH grant application.
- Conditions
- Nicotine Dependence, Smoking, Heavy Drinking
- Being tested
- Extended Varenicline Pretreatment, Short-term Varenicline Pretreatment
- Keywords
- Smoking cessation, Smoking, Tobacco, Varenicline, Alcohol
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Varenicline PretreatmentDrug
Also called chantix
4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
Short-term Varenicline PretreatmentDrug
Also called Placebo
3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
| Study group | Role | What they receive |
|---|---|---|
| Extended Varenicline Pretreatment | Experimental | Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment. Receives: Drug: Extended Varenicline Pretreatment |
| Short-term Varenicline Pretreatment | Experimental | Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date. Receives: Drug: Short-term Varenicline Pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Last 4 weeks of treatment
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.
Measured: First 3 weeks (pretreatment)
Secondary outcomes (1)
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
Measured: First 3 weeks (pretreatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Stephanie S O'Malley, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860028
- Sponsor's protocol ID
- NIAAA-O'Malley-P50AA15632-2009
- Other IDs
- P50AA015632
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2009
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21221531Livingstone-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.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Smoking Cessation in Heavy Drinking Smokers
- ClinicalTrials.gov ID
- NCT00860028
- Acronym / sponsor ID
- NIAAA-O'Malley-P50AA15632-2009
- Conditions
- Nicotine Dependence, Smoking, Heavy Drinking
- Keywords
- Smoking cessation, Smoking, Tobacco, Varenicline, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 7 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Smoking rates are elevated among drinkers compared to non-drinkers (Marks et al., 1997). Moreover, there is some evidence that both smokers who drink alcohol are less successful quitting smoking (Leeman, Huffman, \& O'Malley, 2007). Thus, identifying interventions that are effective in reducing both smoking and heavy drinking in this population is warranted. Varenicline, a medication recently approved by the FDA, results in smoking cessation rates as high as 50%, significantly better than bupropion or placebo. There is preliminary experimental evidence from both animal and human laboratory research that varenicline reduces alcohol seeking and consumption (McKee, 2008; Steensland et al., 2007).
The typical dose schedule for varenicline involves a 1 week pretreatment phase prior to quitting smoking (Gonzales et al., 2006; Jorenby et al., 2006; Nides et al., 2006). However, greater quit rates have been observed 1 month after using varenicline compared to 1 week. Therefore, it is possible that extended pretreatment with varenicline may also yield better cessation outcomes than the standard 1 week lead in period. This may be particularly true if pretreatment also reduces alcohol consumption prior to the quit attempt.
Thirty regular smokers who drink alcohol heavily will receive open-label varenicline for 5 weeks according to the recommended titration schedule up to 1mg varenicline twice daily. Prior to the smoking quit date, subjects will be randomized to receive either extended pretreatment with varenicline (titration up to 1mg) for 4 weeks or short-term varenicline pretreatment (3 weeks placebo followed by 1 week of varenicline).
The primary aims of the study are to examine: (a) the efficacy of extended varenicline pretreatment for smoking cessation, (b) the safety and tolerability of varenicline in heavy drinking smokers, and (c) the efficacy of varenicline for reducing alcohol consumption in human participants. Effect size estimates for prolonged smoking abstinence and heavy drinking will be generated for a NIH grant application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Varenicline Pretreatment | Experimental | Drug: Extended Varenicline PretreatmentArm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment. |
| Short-term Varenicline Pretreatment | Experimental | Drug: Short-term Varenicline PretreatmentArm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 18 and 75.
- Smoking 5 or more cigarettes per occasion at least 3 times per week.
- Fewer than 3 months of smoking abstinence in the past year.
- Motivated to stop smoking.
- 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.
Key exclusion criteria (19 listed)
- Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
- Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
- Clinically significant cardiovascular disease
- Uncontrolled hypertension
- Hepatic or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Varenicline PretreatmentAlso: chantix4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment. | Drug | Extended Varenicline Pretreatment |
| Short-term Varenicline PretreatmentAlso: Placebo3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date. | Drug | Short-term Varenicline Pretreatment |
Primary outcome
Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.
Time frame: Last 4 weeks of treatment
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.
Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions
Time frame: First 3 weeks (pretreatment)
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.
1 secondary outcome
Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions
Time frame: First 3 weeks (pretreatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21221531Fucito 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.
- Derived from this study: PubMed 37142273Livingstone-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.
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie S O'Malley, PhD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extended Varenicline Pretreatment and Short-term Varenicline Pretreatment in people with Nicotine Dependence and Smoking, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (time frame: Last 4 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860028, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.