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Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation (1207)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01685996
Recruitment Status : Completed
First Posted : September 17, 2012
Results First Posted : June 5, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: zonisamide
Drug: placebo
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

participants will receive zonisamide capsules (up to 300 mg) to take once a day.

zonisamide: 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

Participants will receive placebo capsules to take once a day

placebo

Period Title: Overall Study
Started 34 40
Completed 18 27
Not Completed 16 13
Arm/Group Title Zonisamide Placebo Total
Hide Arm/Group Description Participants receive zonisamide + varenicline for smoking cessation Participants receive placebo + varenicline for smoking cessation Total of all reporting groups
Overall Number of Baseline Participants 34 40 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 40 participants 74 participants
45.3  (9.8) 45.9  (9.7) 45.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 participants
Female
8
  23.5%
13
  32.5%
21
  28.4%
Male
26
  76.5%
27
  67.5%
53
  71.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 participants
Hispanic or Latino
0
   0.0%
1
   2.5%
1
   1.4%
Not Hispanic or Latino
34
 100.0%
39
  97.5%
73
  98.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
23
  67.6%
27
  67.5%
50
  67.6%
White
11
  32.4%
13
  32.5%
24
  32.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 40 participants 74 participants
34 40 74
1.Primary Outcome
Title Percent Participants Abstinent From Smoking During Study Weeks 7-10
Hide Description Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.
Time Frame weeks 7-10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

participants will receive zonisamide capsules (up to 300 mg) to take once a day.

zonisamide: 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

Participants will receive placebo capsules to take once a day

placebo

Overall Number of Participants Analyzed 34 40
Measure Type: Count of Participants
Unit of Measure: Participants
5
  14.7%
6
  15.0%
2.Secondary Outcome
Title Nicotine Withdrawal Symptom Severity
Hide Description 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.
Time Frame Past 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

participants will receive zonisamide capsules (up to 300 mg) to take once a day.

zonisamide: 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

Participants will receive placebo capsules to take once a day

placebo

Overall Number of Participants Analyzed 34 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
Screening Visit 4.6  (6.0) 5.6  (5.5)
Admission Visit 5.1  (5.3) 7.0  (6.3)
Week 1 (pre-quit day) 5.3  (6.) 6.2  (7.3)
Week 2 (pre-quit day) 4.8  (6.0) 5.7  (6.3)
Week 3 (target quit day) 4.7  (5.4) 6.6  (7.0)
Week 4 3.8  (5.1) 5.9  (7.0)
Week 5 3.8  (3.7) 4.7  (5.3)
Week 6 3.4  (4.3) 4.0  (5.0)
Week 7 3.8  (4.7) 4.4  (4.7)
Week 8 2.7  (3.3) 4.0  (4.5)
Week 9 3.1  (3.0) 4.1  (4.4)
Week 10 2.6  (4.9) 4.8  (5.8)
Time Frame Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

participants will receive zonisamide capsules (up to 300 mg) to take once a day.

zonisamide: 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

Participants will receive placebo capsules to take once a day

placebo

All-Cause Mortality
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Zonisamide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Zonisamide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/34 (82.35%)      28/40 (70.00%)    
Cardiac disorders     
Chest Pain   2/34 (5.88%)  2 0/40 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain   1/34 (2.94%)  1 1/40 (2.50%)  1
Constipation   5/34 (14.71%)  6 4/40 (10.00%)  4
Diarrhea   2/34 (5.88%)  2 1/40 (2.50%)  1
Dry Mouth   1/34 (2.94%)  1 0/40 (0.00%)  0
Dyspepsia   1/34 (2.94%)  1 0/40 (0.00%)  0
Nausea   11/34 (32.35%)  14 11/40 (27.50%)  14
Sore Throat   1/34 (2.94%)  1 0/40 (0.00%)  0
Vomiting   4/34 (11.76%)  4 2/40 (5.00%)  2
General disorders     
Chills   1/34 (2.94%)  1 0/40 (0.00%)  0
Headache   5/34 (14.71%)  5 4/40 (10.00%)  6
Hepatobiliary disorders     
Chemistry Abnormal   2/34 (5.88%)  2 3/40 (7.50%)  3
Metabolism and nutrition disorders     
Dehydration   0/34 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Back Pain   0/34 (0.00%)  0 1/40 (2.50%)  1
Jaw Pain   0/34 (0.00%)  0 1/40 (2.50%)  1
Pain Lower Extremity   0/34 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders     
Adjustment Disorder   1/34 (2.94%)  1 0/40 (0.00%)  0
Ataxia   1/34 (2.94%)  1 0/40 (0.00%)  0
Difficulty Concentrating   1/34 (2.94%)  1 0/40 (0.00%)  0
Agitation   3/34 (8.82%)  3 1/40 (2.50%)  1
Anxiety   0/34 (0.00%)  0 3/40 (7.50%)  3
Depression   1/34 (2.94%)  1 2/40 (5.00%)  2
Dizziness   3/34 (8.82%)  3 2/40 (5.00%)  2
Dream Abnormal   8/34 (23.53%)  9 7/40 (17.50%)  7
Drowsiness   6/34 (17.65%)  6 4/40 (10.00%)  5
Fatigue   2/34 (5.88%)  2 0/40 (0.00%)  0
Insomnia   7/34 (20.59%)  8 3/40 (7.50%)  3
Irritability   6/34 (17.65%)  6 7/40 (17.50%)  7
Paranoid   1/34 (2.94%)  1 0/40 (0.00%)  0
Paresthesia   1/34 (2.94%)  1 0/40 (0.00%)  0
Restlessness   1/34 (2.94%)  1 0/40 (0.00%)  0
Psychiatric disorders     
Change in Mental Status   0/34 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders     
Sinusitis   0/34 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders     
Skin Rash   1/34 (2.94%)  1 0/40 (0.00%)  0
Pruritis (itching)   1/34 (2.94%)  1 0/40 (0.00%)  0
Sweating Increased   3/34 (8.82%)  3 0/40 (0.00%)  0
Hot Flashes   1/34 (2.94%)  1 0/40 (0.00%)  0
Itching Eyes   1/34 (2.94%)  1 0/40 (0.00%)  0
Pain- Eye   1/34 (2.94%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Annie Umbricht, M.D.
Organization: Johns Hopkins University School of Medicine
Phone: 410-550-1917
EMail: annieumbricht@jhu.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01685996    
Other Study ID Numbers: NA_00074143
R21DA034164 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2012
First Posted: September 17, 2012
Results First Submitted: April 17, 2017
Results First Posted: June 5, 2017
Last Update Posted: January 24, 2018