NCT01685996

Brief Summary

Randomized trial to evaluate whether zonisamide can enhance varenicline-induced smoking cessation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

September 12, 2012

Results QC Date

April 17, 2017

Last Update Submit

January 22, 2018

Conditions

Nicotine Dependence

Keywords

tobaccosmoking cessationnicotinecigarettesnicotine withdrawal

Outcome Measures

Primary Outcomes (1)

  • Percent Participants Abstinent From Smoking During Study Weeks 7-10

    Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.

    weeks 7-10

Secondary Outcomes (1)

  • Nicotine Withdrawal Symptom Severity

    Past 24 hours

Study Arms (2)

zonisamide

EXPERIMENTAL

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

Drug: zonisamide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo capsules to take once a day

Drug: placebo

Interventions

zonisamideDRUG

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

Also known as: zonegran®
zonisamide
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 - 65 years old; smoking \> 10 cigarettes per day for \> 1 year
  • Desire to quit smoking
  • Provide a cotinine positive urine sample
  • Commitment to come to the clinic once a week for the 10-week study duration

You may not qualify if:

  • Allergy to varenicline or sulfonamide drugs (e.g., trimethoprim/sulfamethoxazole, zonisamide or topiramate);
  • Renal insufficiency (eGFR \< 60 mL)
  • Renal tubular acidosis
  • History of nephrolithiasis
  • Unexplained hematuria
  • Transaminase elevations \> 3 times the Upper Limit of Normal (ULN)
  • BMI \< 19
  • Diabetes mellitus
  • Respiratory insufficiency
  • Asthma requiring medication
  • Heart failure
  • Chronic diarrhea predisposing to acidosis
  • Glaucoma, family history of glaucoma, one-sided blindness
  • History of seizures or use of anticonvulsant medications (not including sedatives)
  • HIV infection on HAART medication (or CD4 T cell count \< 200 /mL)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Dunn KE, Marcus TF, Kim C, Schroeder JR, Vandrey R, Umbricht A. Zonisamide Reduces Withdrawal Symptoms But Does Not Enhance Varenicline-Induced Smoking Cessation. Nicotine Tob Res. 2016 May;18(5):1171-9. doi: 10.1093/ntr/ntv236. Epub 2015 Oct 17.

    PMID: 26476459DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Annie Umbricht, M.D.
Organization
Johns Hopkins University School of Medicine
annieumbricht@jhu.edu
410-550-1917

Study Officials

  • 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 annieumbricht@jhu.edu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 17, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 24, 2018

Results First Posted

June 5, 2017

Record last verified: 2018-01

Locations

US(1)