A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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 replacement therapy (NRT) in healthy nicotine dependent smokers

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A. Eden Evins
• Collaborators: FORUM Pharmaceuticals Inc; National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine; Nicotinic Agonists

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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