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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nicotine Dependence; Smoking Cessation

Intervention: EVP-6124 (Drug); Placebo Capsule (Drug); NicoDerm CQ Patch (Active) (Drug); NRT Patch (Placebo) (Drug); Brief Supportive and Behavioral Treatment (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: A. Eden Evins

Official(s) and/or principal investigator(s):
Anne Eden Evins, MD, MPH, Principal Investigator, Affiliation: Massachusetts General Hospital
Maurizio Fava, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Ailish Hanly, BS, Phone: 617-724-8472, Email: a7smoking@partners.org


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

Clinical Details

Official title: Proof-of-Concept Study of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, Versus Placebo in Subjects With Nicotine Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Effects of EVP-6124 on 7-day point-prevalence smoking abstinence

Difference in expired CO concentration

Secondary outcome:

Effects of EVP-6124 on cognitive performance

Safety and tolerability of EVP-6124 alone or combined with NRT


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Self-report of smoking an average of ≥10 cigarettes/day for 6 months and expired 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 hCG pregnancy test at

screening and Day 1 Exclusion Criteria:

- Have unstable medical illness with hospitalization for treatment likely within 6


- 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 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 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

Locations and Contacts

Ailish Hanly, BS, Phone: 617-724-8472, Email: a7smoking@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Additional Information

Starting date: December 2011
Last updated: April 15, 2015

Page last updated: August 23, 2015

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