Smoking Lapse BehaviorPhase 2NCT00580853
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
A Phase 2 study testing varenicline and bupropion in people with Smoking Lapse Behavior, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Smoking Lapse Behavior
- What is being tested?
- varenicline and bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 2016
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ages 18-55
- able to read and write in English
- Smokers
Who cannot join
- any significant current medical or psychiatric conditions that would contraindicate smoking
- current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
- positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- women who are pregnant or nursing
- suicidal, homicidal, or evidence of current severe mental illness
- participants prescribed any psychotropic drug in the 30 days prior to study enrollment
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- blood donation within the past 6 weeks
- individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
- specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
- known allergy to varenicline or taking H2blockers
- participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigation, Yale University
New Haven, Connecticut, 06519
About this study
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.
- Conditions
- Smoking Lapse Behavior
- Being tested
- varenicline, bupropion, Placebo
- Keywords
- smoking lapse behavior, smoking cessation, varenicline, bupropion, medication effect on smoking lapse behavior
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix
2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
bupropionDrug
Also called Zyban
300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Experimental | varenicline 2mg/day Receives: Drug: varenicline |
| Bupropion | Experimental | Bupropion 300mg/day Receives: Drug: bupropion |
| Placebo | Placebo comparator | Placebo Control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to Initiate Ad-lib Smoking Session
minutes to start smoking (range 0 to 50 minutes)
Measured: 0 to 50 minutes
Secondary outcomes (1)
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period
number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2016
- Study completionOct 2016
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.
- Other trials for Smoking Lapse BehaviorStudies 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, Investigator, Outcomes assessor
- Enrolment
- 62 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
- Sherry A McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580853
- Sponsor's protocol ID
- 0702002390
- Other IDs
- P50AA015632
- Status last verified
- Jan 2018
- First submitted
- 25 Dec 2007
- Last updated
- 8 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
- ClinicalTrials.gov ID
- NCT00580853
- Acronym / sponsor ID
- 0702002390
- Conditions
- Smoking Lapse Behavior
- Keywords
- smoking lapse behavior, smoking cessation, varenicline, bupropion, medication effect on smoking lapse behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2007
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 10 Mar 2017
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 examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| varenicline | Experimental | Drug: vareniclinevarenicline 2mg/day |
| Bupropion | Experimental | Drug: bupropionBupropion 300mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Control |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages 18-55
- able to read and write in English
- Smokers
Key exclusion criteria (11 listed)
- any significant current medical or psychiatric conditions that would contraindicate smoking
- current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
- positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- women who are pregnant or nursing
- suicidal, homicidal, or evidence of current severe mental illness
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 |
|---|---|---|
| vareniclineAlso: Chantix2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8). | Drug | varenicline |
| bupropionAlso: Zyban300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8). | Drug | Bupropion |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Latency to Initiate Ad-lib Smoking Session
Time frame: 0 to 50 minutes
minutes to start smoking (range 0 to 50 minutes)
1 secondary outcome
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking Lapse Behavior
Recruiting
Linking Brain Network Dynamics to Imminent Smoking Lapse Risk and Behavior
Smoking, Tobacco Use
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.
Sherry A McKee, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing varenicline and bupropion in people with Smoking Lapse Behavior, run by Yale University at 1 site in United States.
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 3 inclusion and 11 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 10 Mar 2017). 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?
Latency to Initiate Ad-lib Smoking Session (time frame: 0 to 50 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2018.