Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

NCT00755716 | Completed Phase 3 Results

• 3 other identifiers: 06-114-15M01RR006192K24AA013736
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Specific aims:

1. 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. 2.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.
3. 3.To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.

Conditions

Tobacco Dependence

Keywords

nicotine patch; smoking; topiramate

Outcome Measures

Primary Outcomes (1)

• 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.

  weeks 7-10

Secondary Outcomes (1)

• MNWS

  Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.

Study Arms (3)

Placebo (sugar pill)

PLACEBO COMPARATOR

Person receives an inactive placebo

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.

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.

Drug: Topiramate; Drug: Nicotine patch

Interventions

Placebo (sugar pill) DRUG

patients receive

Also known as: sugar pill

Placebo (sugar pill)

Topiramate DRUG

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

Also known as: topimax

Topiramate; Topiramate and Nicotine patch

Nicotine patch DRUG

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.

Also known as: nicoderm

Topiramate and Nicotine patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UConn Health: lead
• National Center for Research Resources (NCRR): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Connecticut Halth Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (2)

• 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.

  PMID: 24057996 RESULT

• Hartmann-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.

  PMID: 34611902 DERIVED

Related Links

• Topiramate for smoking cessation: a randomized, placebo-controlled pilot study

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Sugars; Topiramate; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Carbohydrates; Fructose; Hexoses; Monosaccharides; Ketoses; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Cheryl Oncken
• Organization: UConn Health

oncken@uchc.edu

860-679-3425

Study Officials

• Cheryl A Oncken, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: April 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2013
• Last Updated: August 16, 2017
• Results First Posted: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)