Nicotine DependencePhase 1/2VarenSmokeNCT00571805
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
A Phase 1/2 study testing varencline in people with Nicotine Dependence, run by NYU Langone Health at 1 site in United States.
Trial summary
Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- varencline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 10 cigarettes/day
- Interest in quitting smoking
- Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test
Who cannot join
- Pregnancy
- Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult.
- Clinically significant medical condition in opinion of study clinician
- Drug or alcohol dependence inlast 12 months
- Use of other smoking cessation medications ot treatment progams in last 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
VA New York Harbor Healthcare System, MHAD clinic
New York, New York, 10010
About this study
Official title: Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement
Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.
- Conditions
- Nicotine Dependence
- Being tested
- varencline, placebo
- Keywords
- cigarette, craving, reward
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varenclineDrug
Also called Chantix
2.0 mg/day varencline (1.0 mg BID)
placeboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Varenicline Receives: Drug: varencline |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking reward
Measured: laboratory test
Secondary outcomes (1)
1 week abstinence induced craving and reward
Measured: Day 8, 9, 11 and 14 questionaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Malcolm Reid, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571805
- Sponsor's protocol ID
- Varenicline/Smoking
- Other IDs
- GA30513U
- Acronym
- VarenSmoke
- Status last verified
- Apr 2015
- First submitted
- 11 Dec 2007
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement
- ClinicalTrials.gov ID
- NCT00571805
- Acronym / sponsor ID
- VarenSmoke / Varenicline/Smoking
- Conditions
- Nicotine Dependence
- Keywords
- cigarette, craving, reward
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2007
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: varenclineVarenicline |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 10 cigarettes/day
- Interest in quitting smoking
- Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test
Key exclusion criteria (5 listed)
- Pregnancy
- Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult.
- Clinically significant medical condition in opinion of study clinician
- Drug or alcohol dependence inlast 12 months
- Use of other smoking cessation medications ot treatment progams in last 2 months
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 |
|---|---|---|
| varenclineAlso: Chantix2.0 mg/day varencline (1.0 mg BID) | Drug | 1 |
| placebomatching placebo | Drug | 2 |
Primary outcome
Smoking reward
Time frame: laboratory test
1 secondary outcome
1 week abstinence induced craving and reward
Time frame: Day 8, 9, 11 and 14 questionaires
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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.
Malcolm Reid, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing varencline in people with Nicotine Dependence, run by NYU Langone Health 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 5 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: withdrawn, as of the sponsor's last update on 9 Apr 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Smoking reward (time frame: laboratory test). 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 9 Apr 2015; AzTrials last refreshed its copy on 8 Nov 2026.