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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00755716
First received: September 18, 2008
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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

Condition Intervention Phase
Tobacco Dependence
Drug: Placebo (sugar pill)
Drug: topiramate
Drug: nicotine patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Primary outcome is 4-week continuous quit rate at the end of treatment. [ Time Frame: weeks 5-8, 6-9, and 7-10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes will be weekly 7-day point prevalence cigarette abstinence, questionnaire measurements, and weight. [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (sugar pill)
Person receives an inactive placebo
Drug: Placebo (sugar pill)
patients receive
Other Name: sugar pill
Active Comparator: topiramate
topiramate capsules, 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
Drug: topiramate
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
Other Name: topimax
Active Comparator: nicotine patch
topiramate plus nicotine patch. 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. On the quit date (after 2 weeks of medication use), subjects also use 21mg patch for 8 weeks.
Drug: nicotine patch
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. On the quit date (after 2 weeks of medication use), subjects also use 21mg patch for 8 weeks.
Other Name: nicoderm

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755716

Locations
United States, Connecticut
University of Connecticut Halth Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Cheryl A Oncken, MD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00755716     History of Changes
Other Study ID Numbers: 06-114-1, 006192
Study First Received: September 18, 2008
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
nicotine patch
smoking
topiramate

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Topiramate
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 13, 2014