Tobacco DependencePhase 3NCT00755716
Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
A Phase 3 study testing Topiramate and Nicotine patch in people with Tobacco Dependence, run by UConn Health at 1 site in United States.
Trial summary
Specific aims: 1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of treatment with topiramate or placebo or topiramate plus nicotine patch for smoking cessation. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Topiramate and Nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Aug 2013
- Phase
- Phase 3
- 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
- Male or female cigarette smoker between the ages of 18 and 65 years inclusive and relatively healthy.
- Subjects must smoke an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
- BMI > 18kg/in2.
- Subjects must be free of serious or unstable disease within the past 6 months
- Female subjects must be a) postmenopausal for at least two years, or practicing an effective method of birth control (e.g., surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, spermicide with barrier, contraceptive patch, contraceptive ring, male partner sterilization, abstinence and agree to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence) before entry and throughout the study; have a negative urine pregnancy test at the screening visit. b) agree to avoid pregnancy through 30 days after the last dose of study medication, c) have a negative urine pregnancy test (β-hCG) at screening or baseline and agree to use at least one of the birth control methods as noted in the protocol.
- Subjects must be able to be seen as an outpatient, to be assessed in a clinic setting, and able and willing to comply with all study visits.
- Subjects must be able to provide written consent.
- Subjects must be the only member of the household participating in this study.
Who cannot join
- Subjects who are currently suffering from depression or have been diagnosed with depression or treated with an antidepressant within the past 12 months.
- Subjects who have a past or present history of psychosis, panic disorder, or bipolar disorder.
- Subjects who have severe chronic obstructive pulmonary disease (COPD).4. Subjects who have clinically significant cardiovascular disease in the past 6 months
- Subjects who have clinically significant cardiovascular disease in the past 6 months which includes: myocardial infarction, coronary artery bypass graft CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant ECG conduction abnormalities.
- Subjects who have uncontrolled hypertension or a systolic blood pressure greater than 150 mm Hg or a diastolic blood pressure greater than 95 mm Hg at screening or baseline.
- Subjects who have a history of clinically significant neurological disorders including subjects with seizure disorders, cerebrovascular diseases stroke or transient ischemic attack) and/or progressive or degenerative neurological disorders (e.g., multiple sclerosis) in the past 6 months.
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- Subjects who have a history of clinically significant endocrine disorders or gastrointestinal diseases, including insulin dependent diabetes, uncontrolled hyperthyroidism, and active peptic ulcer.
- Subjects who have clinically significant hepatic or renal impairment (e.g., an estimated creatinine clearance <60 mL/min).
- Subjects who have an SGOT (AST) or SGPT (ALT) concentration greater than 1.5 times the upper limit of normal.
- Subjects who have a history of cancer.
- Subjects who are believed to be medically unstable and/or not appropriate for study participation in the opinion of the principal investigator.
- Subjects who have previously been treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate.
- Subjects with evidence or a history of clinically significant allergic reaction.
- Subjects who have an allergy to adhesive tape or a skin disorder that may be exacerbated by nicotine patch.
- Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months.
- Subjects with a positive urine drug screen.
- Subjects that have been enrolled in a study that included topiramate.
- Subjects who have taken or will plan to take another investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline visit or within 30 days of study completion.
- Subjects who take or plan to take a concomitant medication that is prohibited by this protocol.
- Subjects who require other medications during the study that might interfere with the evaluation of the study drug (for example, nicotine replacement therapy and bupropion).
- Subjects who used a nicotine replacement product, bupropion, clonidine, or nortriptyline within the past 6 months, or participated in a study with an experimental drug for smoking cessation within the past one year.
- Subjects who intend to use non-cigarette tobacco products (including, for example, pipe tobacco, cigars, snuff, chewing tobacco, etc.) or marijuana during study participation.
- Subjects who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of the study treatment.
- Subjects who are unable and/or unlikely to comprehend and follow the study protocol, which includes a) a subject who, in the investigator's opinion, will be unlikely to commit to the duration of the study, b) a subject who, in the investigator's opinion should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the topiramate package insert.
- Subjects who have lactose intolerance.
- Subjects with a history of glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Halth Center
Farmington, Connecticut, 06030
About this study
Specific aims:
- To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of treatment with topiramate or placebo or topiramate plus nicotine patch for smoking cessation.
- To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking satisfaction, and adverse effects during smoking cessation.
- To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.
Read the detailed description
This is a 10-week, randomized, double-blind, single-site study of treatment with either: topiramate, or placebo, or topiramate plus nicotine patch. Approximately, 90 subjects ages 18-65 who smoke at least 10 cigarettes per day will be screened for study participation, with the intention of 60 subjects being eligible for randomized treatment (20 per arm).
- Conditions
- Tobacco Dependence
- Being tested
- Placebo (sugar pill), Topiramate, Nicotine patch
- Keywords
- nicotine patch, smoking, topiramate
- 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.
Placebo (sugar pill)Drug
Also called sugar pill
patients receive
TopiramateDrug
Also called topimax
25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper
Nicotine patchDrug
Also called nicoderm
On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (sugar pill) | Placebo comparator | Person receives an inactive placebo Receives: Drug: Placebo (sugar pill) |
| Topiramate | Active comparator | Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day for a total time of 10 weeks. Receives: Drug: Topiramate |
| Topiramate and Nicotine patch | Active comparator | Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days. Receives: Drug: Topiramate; Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.
The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.
Measured: weeks 7-10
Secondary outcomes (1)
MNWS
Minnesota Nicotine Withdrawing Scale
Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms.
Measured: Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionAug 2013
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 Tobacco DependenceStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Cheryl Oncken, UConn Health
- Investigators
- Cheryl A Oncken, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755716
- Sponsor's protocol ID
- 06-114-1
- Other IDs
- 5M01RR006192, K24AA013736
- Status last verified
- Aug 2017
- First submitted
- 18 Sep 2008
- Last updated
- 16 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oncken C, Arias AJ, Feinn R, Litt M, Covault J, Sofuoglu M, Kranzler HR. Topiramate for smoking cessation: a randomized, placebo-controlled pilot study. Nicotine Tob Res. 2014 Mar;16(3):288-96. doi: 10.1093/ntr/ntt141. Epub 2013 Sep 21.
PubMed 24057996Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
- ClinicalTrials.gov ID
- NCT00755716
- Acronym / sponsor ID
- 06-114-1
- Conditions
- Tobacco Dependence
- Keywords
- nicotine patch, smoking, topiramate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Posted 16 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific aims:
- To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of treatment with topiramate or placebo or topiramate plus nicotine patch for smoking cessation.
- To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking satisfaction, and adverse effects during smoking cessation.
- To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.
Detailed description
This is a 10-week, randomized, double-blind, single-site study of treatment with either: topiramate, or placebo, or topiramate plus nicotine patch. Approximately, 90 subjects ages 18-65 who smoke at least 10 cigarettes per day will be screened for study participation, with the intention of 60 subjects being eligible for randomized treatment (20 per arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (sugar pill) | Placebo comparator | Drug: Placebo (sugar pill)Person receives an inactive placebo |
| Topiramate | Active comparator | Drug: TopiramateSubjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day for a total time of 10 weeks. |
| Topiramate and Nicotine patch | Active comparator | Drug: Topiramate, Drug: Nicotine patchSubjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female cigarette smoker between the ages of 18 and 65 years inclusive and relatively healthy.
- Subjects must smoke an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
- BMI > 18kg/in2.
- Subjects must be free of serious or unstable disease within the past 6 months
- Female subjects must be a) postmenopausal for at least two years, or practicing an effective method of birth control (e.g., surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, spermicide with barrier, contraceptive patch, contraceptive ring, male partner sterilization, abstinence and agree to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence) before entry and throughout the study; have a negative urine pregnancy test at the screening visit. b) agree to avoid pregnancy through 30 days after the last dose of study medication, c) have a negative urine pregnancy test (β-hCG) at screening or baseline and agree to use at least one of the birth control methods as noted in the protocol.
Key exclusion criteria (26 listed)
- Subjects who are currently suffering from depression or have been diagnosed with depression or treated with an antidepressant within the past 12 months.
- Subjects who have a past or present history of psychosis, panic disorder, or bipolar disorder.
- Subjects who have severe chronic obstructive pulmonary disease (COPD).4. Subjects who have clinically significant cardiovascular disease in the past 6 months
- Subjects who have clinically significant cardiovascular disease in the past 6 months which includes: myocardial infarction, coronary artery bypass graft CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant ECG conduction abnormalities.
- Subjects who have uncontrolled hypertension or a systolic blood pressure greater than 150 mm Hg or a diastolic blood pressure greater than 95 mm Hg at screening or baseline.
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 |
|---|---|---|
| Placebo (sugar pill)Also: sugar pillpatients receive | Drug | Placebo (sugar pill) |
| TopiramateAlso: topimax25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper | Drug | Topiramate, Topiramate and Nicotine patch |
| Nicotine patchAlso: nicodermOn the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days. | Drug | Topiramate and Nicotine patch |
Primary outcome
Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.
Time frame: weeks 7-10
The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.
1 secondary outcome
MNWS
Time frame: Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24057996Oncken C, Arias AJ, Feinn R, Litt M, Covault J, Sofuoglu M, Kranzler HR. Topiramate for smoking cessation: a randomized, placebo-controlled pilot study. Nicotine Tob Res. 2014 Mar;16(3):288-96. doi: 10.1093/ntr/ntt141. Epub 2013 Sep 21.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Topiramate for smoking cessation: a randomized, placebo-controlled pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cheryl A Oncken, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topiramate and Nicotine patch in people with Tobacco Dependence, run by UConn 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 8 inclusion and 26 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 Aug 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Aug 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?
Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment. (time frame: weeks 7-10). 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 NCT00755716, 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 16 Aug 2017.