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

This study has been terminated.
(Study has been put on clinical hold by FDA)
Sponsor:
Collaborators:
FORUM Pharmaceuticals Inc
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01480232
First received: November 23, 2011
Last updated: February 21, 2017
Last verified: February 2017
Results First Received: December 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Nicotine Dependence
Smoking Cessation
Interventions: Drug: EVP-6124
Drug: Placebo Capsule
Drug: NicoDerm Patch (Active)
Drug: NRT Patch (Placebo)
Behavioral: Brief Supportive and Behavioral Treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited using advertisements in the local media market.Those who made contact in response to advertisements spoke initially with a research coordinator who provided further information about the study, answered initial questions from the potential subject, and administered a 10-minute questionnaire assessing eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to initiation of any study procedures, the informed consent process was conducted by a study physician who explained the study in detail making sure that the subject understood the potential risks/benefits as outlined in the consent form; 350 signed consent, 60 were found ineligible and 130 either withdrew consent or was discontinued

Reporting Groups
  Description
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)

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

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).

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.

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)

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

NRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).

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.

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)

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

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).

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.

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)

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

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

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.


Participant Flow:   Overall Study
    EVP-6124 + NicoDerm (Active)   EVP-6124 + NRT Patch (Placebo)   Placebo + NicoDerm (Active)   Placebo + NRT Patch (Placebo)
STARTED   40   41   38   41 
COMPLETED   22   19   21   22 
NOT COMPLETED   18   22   17   19 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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)

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

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).

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.

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)

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

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

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.

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)

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

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).

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.

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)

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

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

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.

Total Total of all reporting groups

Baseline Measures
   EVP-6124 + NicoDerm (Active)   EVP-6124 + NRT Patch (Placebo)   Placebo + NicoDerm (Active)   Placebo + NRT Patch (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   41   38   41   160 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.63  (12.17)   44.70  (13.06)   44.03  (12.81)   45.15  (11.42)   44.30  (11.86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      14  35.0%      14  34.1%      13  34.2%      17  41.5%      58  36.3% 
Male      26  65.0%      27  65.9%      25  65.8%      24  58.5%      102  63.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      8  20.0%      4   9.8%      3   7.9%      1   2.4%      16  10.0% 
Not Hispanic or Latino      32  80.0%      37  90.2%      35  92.1%      40  97.6%      144  90.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
White   30   36   29   30   125 
African American   8   3   7   10   28 
Other   2   2   2   1   7 
Years of Regular Smoking 
[Units: Years]
Mean (Standard Deviation)
 23.31  (11.01)   26.38  (13.24)   24.89  (12.84)   26.46  (12.17)   25.26  (12.32) 
Cigarettes Smoked Per Day 
[Units: Cigarettes per day]
Mean (Standard Deviation)
 18.53  (9.35)   19.41  (15.09)   22.87  (30.63)   20.04  (13.85)   20.21  (17.23) 
Expired CO, ppm [1] 
[Units: Parts per million]
Mean (Standard Deviation)
 5.18  (4.17)   4.29  (2.76)   4.78  (3.46)   4.85  (4.38)   4.78  (3.69) 
[1] Measurements of CO in expired breath was the primary means of biochemical verification of smoking self-report during the study at each study visit. End-expiratory CO levels ≥10 ppm indicate current cigarette use, whereas levels of <10 ppm indicate abstinence.
FTND Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.40  (2.07)   5.34  (2.17)   5.39  (1.94)   5.32  (2.07)   5.36  (2.06) 
[1] Fagerström Test for Nicotine Dependence (FTND) will determine the level of nicotine dependence. The scale score ranges from 0 to 10. An FTND score ≥6 indicates high nicotine dependence and a score of <6 indicates a low to moderate level of dependence


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence   [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12 ]

2.  Primary:   Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point   [ Time Frame: Baseline, Weeks 1, 2, 4, 6, 8, 10, 12 ]

3.  Secondary:   Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time   [ Time Frame: Baseline, week 1, week 12 ]

4.  Secondary:   Safety and Tolerability of EVP-6124 Alone or Combined With NRT   [ Time Frame: Weeks 1-12 ]

5.  Secondary:   Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time   [ Time Frame: Baseline, week 1, week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: A. Eden Evins, MD, MPH
Organization: Massachusetts General Hospital-Center for Addiction Medicine
phone: 617-643-4679
e-mail: aeevins@mgh.harvard.edu



Responsible Party: A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01480232     History of Changes
Other Study ID Numbers: EVP-6124-014
1R01DA030992-01 ( US NIH Grant/Contract Award Number )
Study First Received: November 23, 2011
Results First Received: December 15, 2016
Last Updated: February 21, 2017