Nicotine DependenceNCT00602927
Effects of Varenicline on Brain Activity During Nicotine Abstinence
A study testing Varenicline in people with Nicotine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Treatment-seeking smokers between the ages of 18 and 65, that smoke at least 10 cigarettes/day for at least the past 6 months
- Provide a baseline CO (carbon monoxide) reading of >10ppm
- Provide written informed consent and are fluent, English-speaking
- Weight of equal to or less than 300 lbs
Who cannot join
- Smoking Behavior
- Use of chewing tobacco, snuff or cigars
- Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
- Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
- Provide a baseline CO (carbon monoxide) reading ≤10 ppm
- Alcohol/Drug Exclusion Criteria
Show all 47Show fewer
- History of substance abuse and/or currently receiving treatment for substance abuse
- Current alcohol consumption that exceeds 25 standard drinks/week
- A breath alcohol concentration reading ≥ 0.01 at the H\&P (health \& physical) screening or either of the lab sessions
- Medication Exclusion Criteria
- Prior use of Chantix
- Current use or recent discontinuation (within last 14-days) of the following medications:
- Any form of smoking cessation medication
- Any form of anti-psychotic medications that includes:
- antipsychotics,
- atypical antipsychotics,
- mood-stabilizers,
- anti-depressants (tricyclic, SSRI, MAOI),
- anti-panic agents,
- anti-obsessive agents,
- anti-anxiety agents, and
- stimulants (e.g., Provigil, Ritalin)
- herbal medications (St. John's Wort)
- Opioid medication for chronic pain
- Anti-coagulants
- Any heart medications
- Daily medication for asthma
- Medical Exclusion Criteria
- Women who are pregnant, planning a pregnancy, or lactating;
- History or current diagnosis of psychosis, current major depression, bipolar disorder, ADHD, schizophrenia, or any Axis 1 disorder as identified by the MINI
- Serious or unstable disease within the past 6 months (heart disease, HIV)
- Diagnosis of cancer in the past 6 months or if successful treatment for cancer has not ended within the past 6 months
- History of epilepsy or a seizure disorder
- History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90)
- History of kidney and/or liver failure (including transplant)
- History of head trauma or prior seizure; family history of a seizure disorder, brain (or central nervous system) tumor
- Use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI (magnetic resonance imaging);
- Low or borderline intellectual functioning - determined by receiving a score <80 on the Shipley verbal IQ Test
- Non-English speaking; determined at phone screen
- History of claustrophobia (contraindicated for MRI) or color blindness (task requires color recognition); self-report at telephone screen
- Being left-handed
- Any fore-limb deformity
- Wearing cochlear implant or bi-lateral hearing aids
- General Exclusion
- Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
- Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tobacco Use Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.
Read the detailed description
Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.
- Conditions
- Nicotine Dependence
- Being tested
- Varenicline, Placebo
- Keywords
- Varenicline, Imaging, fMRI
- 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.
VareniclineDrug
Also called Chantix
Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily
PlaceboDrug
Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Varenicline | Active comparator | Not described Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change BOLD Signal
We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.
Measured: Day 13
Secondary outcomes (1)
Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)
We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.
Measured: Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2008
- Study completionAug 2008
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 (1)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 University of PennsylvaniaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Cancer Institute (NCI)
- Investigators
- Caryn Lerman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602927
- Sponsor's protocol ID
- 806623
- Other IDs
- GA30517A, P50CA084718
- Status last verified
- May 2011
- First submitted
- 15 Jan 2008
- Last updated
- 10 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Loughead J, Ray R, Wileyto EP, Ruparel K, Sanborn P, Siegel S, Gur RC, Lerman C. Effects of the alpha4beta2 partial agonist varenicline on brain activity and working memory in abstinent smokers. Biol Psychiatry. 2010 Apr 15;67(8):715-21. doi: 10.1016/j.biopsych.2010.01.016. Epub 2010 Mar 6.
PubMed 20207347
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00602927
- Acronym / sponsor ID
- 806623
- Conditions
- Nicotine Dependence
- Keywords
- Varenicline, Imaging, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pfizer, National Cancer Institute (NCI)
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 2 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.
Detailed description
Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Varenicline | Active comparator | Drug: Varenicline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment-seeking smokers between the ages of 18 and 65, that smoke at least 10 cigarettes/day for at least the past 6 months
- Provide a baseline CO (carbon monoxide) reading of >10ppm
- Provide written informed consent and are fluent, English-speaking
- Weight of equal to or less than 300 lbs
Key exclusion criteria (47 listed)
- Smoking Behavior
- Use of chewing tobacco, snuff or cigars
- Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
- Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
- Provide a baseline CO (carbon monoxide) reading ≤10 ppm
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: ChantixDay 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily | Drug | Varenicline |
| PlaceboParticipants will take placebo pills for 13 days using the same regimen as the varenicline study period. | Drug | Placebo |
Primary outcome
Percent Change BOLD Signal
Time frame: Day 13
We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.
1 secondary outcome
Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)
Time frame: Day 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20207347Loughead J, Ray R, Wileyto EP, Ruparel K, Sanborn P, Siegel S, Gur RC, Lerman C. Effects of the alpha4beta2 partial agonist varenicline on brain activity and working memory in abstinent smokers. Biol Psychiatry. 2010 Apr 15;67(8):715-21. doi: 10.1016/j.biopsych.2010.01.016. Epub 2010 Mar 6.
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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.
Caryn Lerman, PhD principal investigator
University of Pennsylvania
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 Nicotine Dependence, run by University of Pennsylvania 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 47 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 10 May 2011. 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 2 May 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?
Percent Change BOLD Signal (time frame: Day 13). 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 NCT00602927, which also lists 1 linked publication.
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 10 May 2011.