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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01480232
Recruitment Status : Terminated (Study has been put on clinical hold by FDA)
First Posted : November 28, 2011
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
FORUM Pharmaceuticals Inc
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (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
Enrollment 345
Recruitment Details 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 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
Arm/Group Title EVP-6124 + NicoDerm (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm (Active) Placebo + NRT Patch (Placebo)
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 40 41 38 41
Completed 22 19 21 22
Not Completed 18 22 17 19
Arm/Group Title EVP-6124 + NicoDerm (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm (Active) Placebo + NRT Patch (Placebo) Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 40 41 38 41 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 participants
42.63  (12.17) 44.70  (13.06) 44.03  (12.81) 45.15  (11.42) 44.30  (11.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 participants
White
30
  75.0%
36
  87.8%
29
  76.3%
30
  73.2%
125
  78.1%
African American
8
  20.0%
3
   7.3%
7
  18.4%
10
  24.4%
28
  17.5%
Other
2
   5.0%
2
   4.9%
2
   5.3%
1
   2.4%
7
   4.4%
Years of Regular Smoking  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 participants
23.31  (11.01) 26.38  (13.24) 24.89  (12.84) 26.46  (12.17) 25.26  (12.32)
Cigarettes Smoked Per Day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 participants
18.53  (9.35) 19.41  (15.09) 22.87  (30.63) 20.04  (13.85) 20.21  (17.23)
Expired CO, ppm   [1] 
Mean (Standard Deviation)
Unit of measure:  Parts per million
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 participants
5.18  (4.17) 4.29  (2.76) 4.78  (3.46) 4.85  (4.38) 4.78  (3.69)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 41 participants 38 participants 41 participants 160 participants
5.40  (2.07) 5.34  (2.17) 5.39  (1.94) 5.32  (2.07) 5.36  (2.06)
[1]
Measure Description: 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
1.Primary Outcome
Title Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Hide Description 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.
Time Frame Week 1, 2, 4, 6, 8, 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment).
Arm/Group Title EVP-6124 + NicoDerm CQ (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm CQ (Active) Placebo + NRT Patch (Placebo)
Hide Arm/Group Description:

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

Overall Number of Participants Analyzed 40 41 38 41
Measure Type: Number
Unit of Measure: % participants with 7-Day Point Prevalen
Seven-Day Point Prevalence Abstinence Rate week 1 25.0 12.2 28.9 17.1
Seven-Day Point Prevalence Abstinence Rate week 2 47.5 19.5 42.1 24.4
Seven-Day Point Prevalence Abstinence Rate week 4 40.0 17.1 44.7 19.5
Seven-Day Point Prevalence Abstinence Rate week 6 52.5 14.6 34.2 22.0
Seven-Day Point Prevalence Abstinence Rate week 8 37.5 14.6 28.9 24.4
Seven-Day Point Prevalence Abstinence Rate week 10 37.5 12.2 23.7 24.4
Seven-Day Point Prevalence Abstinence Rate week 12 25.0 12.2 18.4 19.5
2.Primary Outcome
Title Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Hide Description CO concentration was measured at every visit.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVP-6124 + NicoDerm CQ (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm CQ (Active) Placebo + NRT Patch (Placebo)
Hide Arm/Group Description:

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

Overall Number of Participants Analyzed 40 41 38 41
Mean (Standard Deviation)
Unit of Measure: part per million
Baseline 20.2  (11) 17.2  (9.8) 20.5  (13.7) 19.3  (9.4)
Week 1 8.6  (11) 9.2  (10.1) 5.2  (6) 8.1  (8.6)
Week 2 7.7  (11.5) 10.1  (10.2) 4.9  (5.4) 8.5  (8.5)
Week 4 6.1  (7.7) 9.8  (11.5) 6.3  (7.9) 9.6  (10.5)
Week 6 7.5  (11.4) 12.7  (16.3) 5.3  (5.7) 7.8  (6.4)
Week 8 7.2  (10.5) 12.6  (16.8) 7.5  (6.4) 7.6  (6.8)
Week 10 7.2  (10.9) 11.2  (11.9) 8.2  (7.4) 5.3  (5)
Week 12 8.8  (8.7) 11.4  (13.6) 9  (8.1) 8.3  (9.3)
3.Secondary Outcome
Title Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time
Hide Description The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an 'X'. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure.
Time Frame Baseline, week 1, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVP-6124 + NicoDerm CQ (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm CQ (Active) Placebo + NRT Patch (Placebo)
Hide Arm/Group Description:

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

Overall Number of Participants Analyzed 40 41 38 41
Mean (Standard Deviation)
Unit of Measure: mili seconds
Baseline Hit RT 436.26  (78.15) 434.72  (65.40) 427.76  (66.87) 423.94  (72.58)
Week 1 Hit RT 424.77  (76.85) 429.99  (59.94) 418.74  (60.32) 407.97  (68.01)
Week 12 Hit RT 441.73  (71.59) 421.66  (67.67) 432.56  (73.91) 396.78  (53.44)
4.Secondary Outcome
Title Safety and Tolerability of EVP-6124 Alone or Combined With NRT
Hide Description All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVP-6124 + NicoDerm CQ (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm CQ (Active) Placebo + NRT Patch (Placebo)
Hide Arm/Group Description:

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

Overall Number of Participants Analyzed 40 41 38 41
Measure Type: Count of Participants
Unit of Measure: Participants
35
  87.5%
30
  73.2%
34
  89.5%
34
  82.9%
5.Secondary Outcome
Title Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Hide Description This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT)
Time Frame Baseline, week 1, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVP-6124 + NicoDerm CQ (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm CQ (Active) Placebo + NRT Patch (Placebo)
Hide Arm/Group Description:

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

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

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

NicoDerm CQ Patch (Active): One NicoDerm CQ 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.

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.

Overall Number of Participants Analyzed 40 41 38 41
Mean (Standard Deviation)
Unit of Measure: mili seconds
Baseline 2-Back RT 634.04  (166.51) 645.01  (180.83) 632.80  (176.78) 616.33  (186.83)
Baseline 3-Back RT 667.75  (202.35) 642.89  (182.20) 620.55  (210.04) 600.78  (179.64)
Week 1 2-Back RT 578.58  (101.86) 619.42  (174.86) 565.84  (148.24) 553.90  (135.00)
Week 1 3-Back RT 635.08  (164.16) 627.85  (180.06) 608.94  (152.38) 586.15  (173.28)
Week 12 2-Back RT 608.03  (145.92) 620.28  (175.61) 598.47  (156.28) 565.41  (149.08)
Week 12 3-Back RT 639.51  (175.91) 613.75  (176.40) 611.85  (185.75) 585.15  (177.86)
Time Frame week 1 to week 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EVP-6124 + NicoDerm (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm (Active) Placebo + NRT Patch (Placebo)
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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.

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.

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.

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.

All-Cause Mortality
EVP-6124 + NicoDerm (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm (Active) Placebo + NRT Patch (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
EVP-6124 + NicoDerm (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm (Active) Placebo + NRT Patch (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      1/41 (2.44%)      1/38 (2.63%)      0/41 (0.00%)    
Gastrointestinal disorders         
Diverticulitis Flare   0/40 (0.00%)  0 1/41 (2.44%)  1 0/38 (0.00%)  0 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pneumonia   1/40 (2.50%)  1 0/41 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EVP-6124 + NicoDerm (Active) EVP-6124 + NRT Patch (Placebo) Placebo + NicoDerm (Active) Placebo + NRT Patch (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/40 (87.50%)      30/41 (73.17%)      34/38 (89.47%)      34/41 (82.93%)    
Gastrointestinal disorders         
Constipation   11/40 (27.50%)  11 8/41 (19.51%)  8 8/38 (21.05%)  8 5/41 (12.20%)  5
Stomach pain   3/40 (7.50%)  3 5/41 (12.20%)  5 0/38 (0.00%)  0 0/41 (0.00%)  0
General disorders         
Elevated Creatine phosphokinase (CPK)   2/40 (5.00%)  2 0/41 (0.00%)  0 4/38 (10.53%)  4 3/41 (7.32%)  3
Headache   10/40 (25.00%)  10 2/41 (4.88%)  2 2/38 (5.26%)  2 4/41 (9.76%)  4
Fatigue   5/40 (12.50%)  5 2/41 (4.88%)  2 2/38 (5.26%)  2 2/41 (4.88%)  2
Insomnia   6/40 (15.00%)  6 3/41 (7.32%)  3 6/38 (15.79%)  6 5/41 (12.20%)  5
Nausea   3/40 (7.50%)  3 1/41 (2.44%)  1 3/38 (7.89%)  3 0/41 (0.00%)  0
weight gain   2/40 (5.00%)  2 2/41 (4.88%)  2 1/38 (2.63%)  1 0/41 (0.00%)  0
Irritability   4/40 (10.00%)  4 1/41 (2.44%)  1 1/38 (2.63%)  1 3/41 (7.32%)  3
Increase appetite   1/40 (2.50%)  1 2/41 (4.88%)  2 1/38 (2.63%)  1 2/41 (4.88%)  2
Allergies   6/40 (15.00%)  6 2/41 (4.88%)  2 3/38 (7.89%)  3 3/41 (7.32%)  3
Abnormal sleeping pattern   5/40 (12.50%)  5 1/41 (2.44%)  1 5/38 (13.16%)  5 2/41 (4.88%)  2
Infections and infestations         
Cold/flu   7/40 (17.50%)  7 3/41 (7.32%)  3 7/38 (18.42%)  7 3/41 (7.32%)  3
Musculoskeletal and connective tissue disorders         
Muscle spasm   7/40 (17.50%)  7 2/41 (4.88%)  2 0/38 (0.00%)  0 1/41 (2.44%)  1
Psychiatric disorders         
Depressive symptoms   2/40 (5.00%)  2 1/41 (2.44%)  1 0/38 (0.00%)  0 4/41 (9.76%)  4
Anxiety   2/40 (5.00%)  2 4/41 (9.76%)  4 1/38 (2.63%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Upper respiratory infection   10/40 (25.00%)  10 4/41 (9.76%)  4 7/38 (18.42%)  7 7/41 (17.07%) 
Skin and subcutaneous tissue disorders         
Skin Irritation at Patch Site   12/40 (30.00%)  12 3/41 (7.32%)  3 2/38 (5.26%)  2 3/41 (7.32%)  3
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: A. Eden Evins, MD, MPH
Organization: Massachusetts General Hospital-Center for Addiction Medicine
Phone: 617-643-4679
EMail: aeevins@mgh.harvard.edu
Layout table for additonal information
Responsible Party: A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01480232    
Other Study ID Numbers: EVP-6124-014
1R01DA030992-01 ( U.S. NIH Grant/Contract )
First Submitted: November 23, 2011
First Posted: November 28, 2011
Results First Submitted: December 15, 2016
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017