Tobacco DependenceNCT00747643
Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
A study testing varenicline in people with Tobacco Dependence, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2010
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years of age
- Smoke at least 15 cigarettes daily
- Expired-air carbon monoxide (CO) > 10 ppm
- Medically eligible to receive Varenicline.
Who cannot join
- Patients who are pregnant or lactating
- Who show evidence of renal dysfunction (BUN > 25 mg/dL, or creatinine > 1.3 mg/dL)
- Are using other smoking cessation medications
- Have current psychiatric disorders (i.e. major depression, manic depression, and/or psychotic episodes) as determined by the Structured Clinical Interview for DSM Disorders (SCID) (First et al., 1996), will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.
Read the detailed description
We proposed the following primary hypotheses:
- Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
- Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.)
- The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.)
A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).
Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.
- Conditions
- Tobacco Dependence
- Being tested
- varenicline, placebo
- Keywords
- tobacco, nicotine, smoking, reward, reinforcement, craving, cues, conditioned stimuli, cue reactivity
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix™
Participants in this group received varenicline according to the schedule in the Arm Description.
placeboDrug
Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Active comparator | For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. Receives: Drug: varenicline |
| Placebo | Placebo comparator | Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tonic Craving Score (QSU) Based on Self Reports
Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.
Measured: 3 weeks per participant
Cue-provoked Cravings
Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"
Measured: 3 weeks per participant
Secondary outcomes (2)
Smoking Topography - Number of Puffs on a Cigarette
# Puffs = total number of puffs taken at Assessment Session.
Measured: 3 weeks per participant
A Measure of the Subjective Expected Value of a Cigarette
The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).
Measured: 3 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionAug 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.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Thomas Brandon, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747643
- Sponsor's protocol ID
- MCC-15444
- Other IDs
- 106842
- Status last verified
- Oct 2011
- First submitted
- 4 Sep 2008
- Last updated
- 16 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
- ClinicalTrials.gov ID
- NCT00747643
- Acronym / sponsor ID
- MCC-15444
- Conditions
- Tobacco Dependence
- Keywords
- tobacco, nicotine, smoking, reward, reinforcement, craving, cues, conditioned stimuli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 29 Nov 2011
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 was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.
Detailed description
We proposed the following primary hypotheses:
- Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
- Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.)
- The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.)
A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).
Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: vareniclineFor participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. |
| Placebo | Placebo comparator | Drug: placeboParticipants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-60 years of age
- Smoke at least 15 cigarettes daily
- Expired-air carbon monoxide (CO) > 10 ppm
- Medically eligible to receive Varenicline.
Key exclusion criteria (4 listed)
- Patients who are pregnant or lactating
- Who show evidence of renal dysfunction (BUN > 25 mg/dL, or creatinine > 1.3 mg/dL)
- Are using other smoking cessation medications
- Have current psychiatric disorders (i.e. major depression, manic depression, and/or psychotic episodes) as determined by the Structured Clinical Interview for DSM Disorders (SCID) (First et al., 1996), will be excluded
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: Chantix™Participants in this group received varenicline according to the schedule in the Arm Description. | Drug | Varenicline |
| placeboParticipants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description. | Drug | Placebo |
Primary outcome
Tonic Craving Score (QSU) Based on Self Reports
Time frame: 3 weeks per participant
Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.
Cue-provoked Cravings
Time frame: 3 weeks per participant
Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"
2 secondary outcomes
Smoking Topography - Number of Puffs on a Cigarette
Time frame: 3 weeks per participant
A Measure of the Subjective Expected Value of a Cigarette
Time frame: 3 weeks per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Brandon, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varenicline in people with Tobacco Dependence, run by H. Lee Moffitt Cancer Center and Research Institute 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 4 inclusion and 4 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 16 Dec 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2011). 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?
Tonic Craving Score (QSU) Based on Self Reports (time frame: 3 weeks per participant). 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?
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 16 Dec 2013.