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

NCT ID: NCT01480232

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-09-30

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 replacement therapy (NRT) in healthy nicotine dependent smokers

Conditions

Nicotine Dependence; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EVP-6124 + NicoDerm (Active)

One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)

Group Type: EXPERIMENTAL

EVP-6124

Intervention Type: DRUG

One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)

NicoDerm Patch (Active)

Intervention Type: DRUG

One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).

Brief Supportive and Behavioral Treatment

Intervention Type: BEHAVIORAL

Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Placebo + NicoDerm (Active)

One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)

Group Type: ACTIVE_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

One placebo capsule ingested orally daily for 12 weeks (84 days)

NicoDerm Patch (Active)

Intervention Type: DRUG

One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).

Brief Supportive and Behavioral Treatment

Intervention Type: BEHAVIORAL

Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

EVP-6124 + NRT Patch (Placebo)

One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)

Group Type: EXPERIMENTAL

EVP-6124

Intervention Type: DRUG

One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)

NRT Patch (Placebo)

Intervention Type: DRUG

One NRT patch (Placebo) daily for first 6 weeks (42 days).

Brief Supportive and Behavioral Treatment

Intervention Type: BEHAVIORAL

Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Placebo + NRT Patch (Placebo)

One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

One placebo capsule ingested orally daily for 12 weeks (84 days)

NRT Patch (Placebo)

Intervention Type: DRUG

One NRT patch (Placebo) daily for first 6 weeks (42 days).

Brief Supportive and Behavioral Treatment

Intervention Type: BEHAVIORAL

Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Interventions

EVP-6124

One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)

Intervention Type: DRUG

Placebo Capsule

One placebo capsule ingested orally daily for 12 weeks (84 days)

Intervention Type: DRUG

NicoDerm Patch (Active)

One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).

Intervention Type: DRUG

NRT Patch (Placebo)

One NRT patch (Placebo) daily for first 6 weeks (42 days).

Intervention Type: DRUG

Brief Supportive and Behavioral Treatment

Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FORUM Pharmaceuticals Inc

INDUSTRY

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

A. Eden Evins

OTHER

Sponsor Role: lead

Responsible Party

A. Eden Evins

Director, Center for Addiction Medicine Massachusetts General Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anne Eden Evins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Maurizio Fava, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R01DA030992-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EVP-6124-014

Identifier Type: -

Identifier Source: org_study_id