Status:
TERMINATED
A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence
Lead Sponsor:
A. Eden Evins
Collaborating Sponsors:
FORUM Pharmaceuticals Inc
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine repl...
Eligibility Criteria
Inclusion
- Self-report of smoking an average of ≥10 cigarettes/day for 6 months and expired carbon monoxide (CO) ≥10 parts per million (ppm) or urine cotinine ≥ 100 ng/mL at screening or self-report of smoking an average of 5-9 cigarettes/day for 6 months and a urine cotinine ≥30ng/ml at screening
- Have a negative urine drug screen at screening
- Fertile, sexually active subjects (males and females) must use an effective method of contraception from the first dose of study drug and for 3 months after the last dose of study drug
- If female and capable of conception, must have a negative urine Human chorionic gonadotrophin (hCG) pregnancy test at screening and Day 1
Exclusion
- Have unstable medical illness with hospitalization for treatment likely within 6 months
- Have life-threatening arrhythmia, cerebrovascular or cardiovascular event within 6 months of enrollment
- Have liver function tests elevated \>2.5 times the upper limit of normal range
- Have a tumor or a seizure disorder
- Currently using other tobacco- or nicotine-containing products and unwilling to try to quit
- Have a 6-month history of substance use disorder other than nicotine or caffeine or major depressive disorder
- Have a history of multiple adverse drug reactions
- Non-response (past 3 months) to nicotine replacement therapy (NRT) \>20 mg/day, bupropion \>150 mg/day, or varenicline 2 mg/day for ≥4 weeks
- Use of excluded concomitant medications
- Hospitalization for any reason within 30 days of screening
- Use of any investigational drug or device within 30 days of screening
- Have clinically significant abnormal serum electrolytes
- Have insufficiently controlled diabetes mellitus
- Have renal insufficiency (serum creatinine \>1.8 mg/dL)
- Malignant tumor within the last 5 years, with the exception of squamous and basal cell carcinoma or cervical carcinoma in situ
- Have a clinically significant cardiovascular abnormality on the screening EKG
- Lifetime history of schizophrenia, bipolar disorder, post-traumatic stress disorder, bulimia, organic mental disorder, dementia, pervasive developmental disorder
- Have untreated, clinically significant hypothyroidism or hyperthyroidism
- Have a positive self-report of human immunodeficiency virus infection
- Females who are pregnant or nursing
- Any experimental drug currently or within 30 days before baseline
- Have a serious risk of suicide
- Have a screening electrocardiogram (ECG) with a corrected QT (QTc) interval using Bazett's formula \>450 msec for males and \>470 msec for females or the presence of any clinically significant cardiac abnormalities
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT01480232
Start Date
December 1 2011
End Date
September 1 2015
Last Update
April 6 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114