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

NCT01480232 | Terminated Phase 2 Results DMC

• 2 other identifiers: EVP-6124-0141R01DA030992-01
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence

  Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) \<10 ppm and/or urine cotinine \<50 ng/mL.

  Week 1, 2, 4, 6, 8, 10, 12

• Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point

  CO concentration was measured at every visit.

  Baseline, Weeks 1, 2, 4, 6, 8, 10, 12

Secondary Outcomes (3)

• Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time

  Baseline, week 1, week 12

• Safety and Tolerability of EVP-6124 Alone or Combined With NRT

  Weeks 1-12

• Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time

  Baseline, week 1, week 12

Study Arms (4)

EVP-6124 + NicoDerm (Active)

EXPERIMENTAL

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

Drug: EVP-6124; Drug: NicoDerm Patch (Active); Behavioral: Brief Supportive and Behavioral Treatment

Placebo + NicoDerm (Active)

ACTIVE COMPARATOR

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

Drug: Placebo Capsule; Drug: NicoDerm Patch (Active); Behavioral: Brief Supportive and Behavioral Treatment

EVP-6124 + NRT Patch (Placebo)

EXPERIMENTAL

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

Drug: EVP-6124; Drug: NRT Patch (Placebo); Behavioral: Brief Supportive and Behavioral Treatment

Placebo + NRT Patch (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Capsule; Drug: NRT Patch (Placebo); Behavioral: Brief Supportive and Behavioral Treatment

Interventions

EVP-6124 DRUG

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

EVP-6124 + NRT Patch (Placebo); EVP-6124 + NicoDerm (Active)

Placebo Capsule DRUG

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

Placebo + NRT Patch (Placebo); Placebo + NicoDerm (Active)

NicoDerm Patch (Active) 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).

EVP-6124 + NicoDerm (Active); Placebo + NicoDerm (Active)

NRT Patch (Placebo) DRUG

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

EVP-6124 + NRT Patch (Placebo); Placebo + NRT Patch (Placebo)

Brief Supportive and Behavioral Treatment 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); EVP-6124 + NicoDerm (Active); Placebo + NRT Patch (Placebo); Placebo + NicoDerm (Active)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A. Eden Evins: lead
• FORUM Pharmaceuticals Inc: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide; Exercise; Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: A. Eden Evins, MD, MPH
• Organization: Massachusetts General Hospital-Center for Addiction Medicine

aeevins@mgh.harvard.edu

617-643-4679

Study Officials

• Anne Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center for Addiction Medicine Massachusetts General Hospital

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-02

Locations

US (1)