Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation

NCT00280839 | Completed Phase 3

• 1 other identifier: CAPSS-298
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation

Conditions

Smoking Cessation

Study Arms (2)

topiramate

ACTIVE COMPARATOR

Drug: Topiramate

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Topiramate DRUG

topiramate

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria before entering the study:
• Subjects who are daily smokers and smoke an average of ≥10 cigarettes/day within the 2 months prior to Visit 1 (Day -7).
• Subjects must score ≥6 on the Motivation Scale.
• Subjects must have a BMI ≥18 kg/m2.
• Subjects must be between 18 and 65 years of age, inclusive.
• Subjects can be male or female and must be in generally good health as confirmed by medical history, baseline psychiatric history, physical examination, laboratory tests and vital signs.
• Female subjects must be:
• postmenopausal for at least one year, 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 Visit 1 (Day -7).
• Subjects must be able to take oral medication, adhere to the medication regimens and be willing to return for regular visits. CAPSS-298 Amendment 2 9 April 7, 2004
• Subjects must be able and willing to read written instructions and complete all scales and inventories required by the protocol.
• Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Subjects who have a current or recent (within 12 months of Visit 2, Day 1) MINI diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence).
• Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-TR™ and supported by the MINI, other than nicotine dependence, that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
• Subjects with a history of personality disorder (e.g., schizotypal or borderline) considered by the investigator to likely interfere with assessment or compliance with treatment.
• Subjects who have begun to receive formal psychotherapy (cognitive-behavioral therapy, behavioral therapy, or self-guided cognitive-behavioral therapy), hypnosis, acupuncture, or other non-pharmacological therapy for smoking cessation or any other psychiatric disorder within 3 months prior to Visit 1 (Day -7). Note: Subjects who have been engaged in formal psychotherapy for treatment other than nicotine dependence for \>3 months and plan to maintain therapy throughout the study will be considered on a case-by-case basis.
• Subjects who have received a prohibited medication described in the Concomitant Therapy section of the protocol and who have not met the washout criteria specified in Attachment 1.
• Subjects who are considered to represent a significant risk of suicidal or violent behavior in the judgment of the investigator.
• Female subjects who are pregnant or lactating.
• Subjects with a history of nephrolithiasis.
• Subjects known to have clinically significant medical conditions, including but not limited to:
• symptomatic coronary artery or peripheral vascular disease;
• malignancy or history of malignancy within the past 5 years (except basal cell carcinoma);
• renal disease and/or impaired renal function as defined by subjects with an estimated creatinine clearance of ≤60 mL/min; CAPSS-298 Amendment 2 10 April 7, 2004
• diseases of the gastrointestinal system including active liver disease;
• subjects with AST and/or ALT \>2 times the upper limit of the normal range and/or serum bilirubin \>2 times the upper limit of normal at Visit 1 (Day -7); Note: if these values are abnormal they can be retested prior to Visit 2 (Day 1). If the repeat study is within the limits of the protocol, the subject may be randomized.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Ortho-McNeil Neurologics, Inc.: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• Anthenelli RM, Blom TJ, McElroy SL, Keck PE Jr. Preliminary evidence for gender-specific effects of topiramate as a potential aid to smoking cessation. Addiction. 2008 Apr;103(4):687-94. doi: 10.1111/j.1360-0443.2008.02148.x.

  PMID: 18339115 RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Paul Keck, Jr., MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

US (1)