Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation (1207)
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|ClinicalTrials.gov Identifier: NCT01685996|
Recruitment Status : Completed
First Posted : September 17, 2012
Results First Posted : June 5, 2017
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: zonisamide Drug: placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
participants will receive zonisamide capsules (up to 300 mg) to take once a day.
In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline
Other Name: zonegran®
Placebo Comparator: Placebo
Participants will receive placebo capsules to take once a day
- Percent Participants Abstinent From Smoking During Study Weeks 7-10 [ Time Frame: weeks 7-10 ]Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.
- Nicotine Withdrawal Symptom Severity [ Time Frame: Past 24 hours ]Total Score from the Minnesota Nicotine Withdrawal Questionnaire (MNWQ), assessed at weekly visits. The MNWQ is a commonly-used 12-item Likert scale self-report measure of nicotine symptoms. Individual symptoms were rated from 0 (none) to 4 (severe) for each item and the Total score range was 0 - 48. Ratings were collected once weekly during study visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685996
|United States, Maryland|
|Behavioral Pharmacology Research Unit|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Annie Umbricht, M.D.||Assistant Professor Behavioral Pharmacology Research Unit The Johns Hopkins University School of Medicine 5510 Nathan Shock Drive Baltimore, MD 21224 tel: 410-550-1917 fax:410-550-0011 firstname.lastname@example.org|