Trial Outcomes & Findings for A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence (NCT NCT01480232)
NCT ID: NCT01480232
Last Updated: 2017-04-06
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
345 participants
Primary outcome timeframe
Week 1, 2, 4, 6, 8, 10, 12
Results posted on
2017-04-06
Participant Flow
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.
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
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
38
|
41
|
|
Overall Study
COMPLETED
|
22
|
19
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
18
|
22
|
17
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence
Baseline characteristics by cohort
| Measure |
EVP-6124 + NicoDerm (Active)
n=40 Participants
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)
n=41 Participants
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)
n=38 Participants
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)
n=41 Participants
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
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.63 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
44.70 years
STANDARD_DEVIATION 13.06 • n=7 Participants
|
44.03 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
45.15 years
STANDARD_DEVIATION 11.42 • n=4 Participants
|
44.30 years
STANDARD_DEVIATION 11.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Years of Regular Smoking
|
23.31 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
26.38 years
STANDARD_DEVIATION 13.24 • n=7 Participants
|
24.89 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
26.46 years
STANDARD_DEVIATION 12.17 • n=4 Participants
|
25.26 years
STANDARD_DEVIATION 12.32 • n=21 Participants
|
|
Cigarettes Smoked Per Day
|
18.53 cigarettes per day
STANDARD_DEVIATION 9.35 • n=5 Participants
|
19.41 cigarettes per day
STANDARD_DEVIATION 15.09 • n=7 Participants
|
22.87 cigarettes per day
STANDARD_DEVIATION 30.63 • n=5 Participants
|
20.04 cigarettes per day
STANDARD_DEVIATION 13.85 • n=4 Participants
|
20.21 cigarettes per day
STANDARD_DEVIATION 17.23 • n=21 Participants
|
|
Expired CO, ppm
|
5.18 parts per million
STANDARD_DEVIATION 4.17 • n=5 Participants
|
4.29 parts per million
STANDARD_DEVIATION 2.76 • n=7 Participants
|
4.78 parts per million
STANDARD_DEVIATION 3.46 • n=5 Participants
|
4.85 parts per million
STANDARD_DEVIATION 4.38 • n=4 Participants
|
4.78 parts per million
STANDARD_DEVIATION 3.69 • n=21 Participants
|
|
FTND Score
|
5.40 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
5.34 units on a scale
STANDARD_DEVIATION 2.17 • n=7 Participants
|
5.39 units on a scale
STANDARD_DEVIATION 1.94 • n=5 Participants
|
5.32 units on a scale
STANDARD_DEVIATION 2.07 • n=4 Participants
|
5.36 units on a scale
STANDARD_DEVIATION 2.06 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 10, 12Population: The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment).
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.
Outcome measures
| Measure |
EVP-6124 + NicoDerm CQ (Active)
n=40 Participants
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.
|
EVP-6124 + NRT Patch (Placebo)
n=41 Participants
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 CQ (Active)
n=38 Participants
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.
|
Placebo + NRT Patch (Placebo)
n=41 Participants
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.
|
|---|---|---|---|---|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 1
|
25.0 % participants with 7-Day Point Prevalen
|
12.2 % participants with 7-Day Point Prevalen
|
28.9 % participants with 7-Day Point Prevalen
|
17.1 % participants with 7-Day Point Prevalen
|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 2
|
47.5 % participants with 7-Day Point Prevalen
|
19.5 % participants with 7-Day Point Prevalen
|
42.1 % participants with 7-Day Point Prevalen
|
24.4 % participants with 7-Day Point Prevalen
|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 4
|
40.0 % participants with 7-Day Point Prevalen
|
17.1 % participants with 7-Day Point Prevalen
|
44.7 % participants with 7-Day Point Prevalen
|
19.5 % participants with 7-Day Point Prevalen
|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 6
|
52.5 % participants with 7-Day Point Prevalen
|
14.6 % participants with 7-Day Point Prevalen
|
34.2 % participants with 7-Day Point Prevalen
|
22.0 % participants with 7-Day Point Prevalen
|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 8
|
37.5 % participants with 7-Day Point Prevalen
|
14.6 % participants with 7-Day Point Prevalen
|
28.9 % participants with 7-Day Point Prevalen
|
24.4 % participants with 7-Day Point Prevalen
|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 10
|
37.5 % participants with 7-Day Point Prevalen
|
12.2 % participants with 7-Day Point Prevalen
|
23.7 % participants with 7-Day Point Prevalen
|
24.4 % participants with 7-Day Point Prevalen
|
|
Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence
Seven-Day Point Prevalence Abstinence Rate week 12
|
25.0 % participants with 7-Day Point Prevalen
|
12.2 % participants with 7-Day Point Prevalen
|
18.4 % participants with 7-Day Point Prevalen
|
19.5 % participants with 7-Day Point Prevalen
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 10, 12CO concentration was measured at every visit.
Outcome measures
| Measure |
EVP-6124 + NicoDerm CQ (Active)
n=40 Participants
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.
|
EVP-6124 + NRT Patch (Placebo)
n=41 Participants
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 CQ (Active)
n=38 Participants
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.
|
Placebo + NRT Patch (Placebo)
n=41 Participants
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.
|
|---|---|---|---|---|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 8
|
7.2 part per million
Standard Deviation 10.5
|
12.6 part per million
Standard Deviation 16.8
|
7.5 part per million
Standard Deviation 6.4
|
7.6 part per million
Standard Deviation 6.8
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Baseline
|
20.2 part per million
Standard Deviation 11
|
17.2 part per million
Standard Deviation 9.8
|
20.5 part per million
Standard Deviation 13.7
|
19.3 part per million
Standard Deviation 9.4
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 1
|
8.6 part per million
Standard Deviation 11
|
9.2 part per million
Standard Deviation 10.1
|
5.2 part per million
Standard Deviation 6
|
8.1 part per million
Standard Deviation 8.6
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 2
|
7.7 part per million
Standard Deviation 11.5
|
10.1 part per million
Standard Deviation 10.2
|
4.9 part per million
Standard Deviation 5.4
|
8.5 part per million
Standard Deviation 8.5
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 4
|
6.1 part per million
Standard Deviation 7.7
|
9.8 part per million
Standard Deviation 11.5
|
6.3 part per million
Standard Deviation 7.9
|
9.6 part per million
Standard Deviation 10.5
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 6
|
7.5 part per million
Standard Deviation 11.4
|
12.7 part per million
Standard Deviation 16.3
|
5.3 part per million
Standard Deviation 5.7
|
7.8 part per million
Standard Deviation 6.4
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 10
|
7.2 part per million
Standard Deviation 10.9
|
11.2 part per million
Standard Deviation 11.9
|
8.2 part per million
Standard Deviation 7.4
|
5.3 part per million
Standard Deviation 5
|
|
Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point
Week 12
|
8.8 part per million
Standard Deviation 8.7
|
11.4 part per million
Standard Deviation 13.6
|
9 part per million
Standard Deviation 8.1
|
8.3 part per million
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 12The 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.
Outcome measures
| Measure |
EVP-6124 + NicoDerm CQ (Active)
n=40 Participants
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.
|
EVP-6124 + NRT Patch (Placebo)
n=41 Participants
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 CQ (Active)
n=38 Participants
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.
|
Placebo + NRT Patch (Placebo)
n=41 Participants
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.
|
|---|---|---|---|---|
|
Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time
Baseline Hit RT
|
436.26 mili seconds
Standard Deviation 78.15
|
434.72 mili seconds
Standard Deviation 65.40
|
427.76 mili seconds
Standard Deviation 66.87
|
423.94 mili seconds
Standard Deviation 72.58
|
|
Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time
Week 1 Hit RT
|
424.77 mili seconds
Standard Deviation 76.85
|
429.99 mili seconds
Standard Deviation 59.94
|
418.74 mili seconds
Standard Deviation 60.32
|
407.97 mili seconds
Standard Deviation 68.01
|
|
Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time
Week 12 Hit RT
|
441.73 mili seconds
Standard Deviation 71.59
|
421.66 mili seconds
Standard Deviation 67.67
|
432.56 mili seconds
Standard Deviation 73.91
|
396.78 mili seconds
Standard Deviation 53.44
|
SECONDARY outcome
Timeframe: Weeks 1-12All 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
Outcome measures
| Measure |
EVP-6124 + NicoDerm CQ (Active)
n=40 Participants
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.
|
EVP-6124 + NRT Patch (Placebo)
n=41 Participants
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 CQ (Active)
n=38 Participants
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.
|
Placebo + NRT Patch (Placebo)
n=41 Participants
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.
|
|---|---|---|---|---|
|
Safety and Tolerability of EVP-6124 Alone or Combined With NRT
|
35 Participants
|
30 Participants
|
34 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 12This 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)
Outcome measures
| Measure |
EVP-6124 + NicoDerm CQ (Active)
n=40 Participants
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.
|
EVP-6124 + NRT Patch (Placebo)
n=41 Participants
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 CQ (Active)
n=38 Participants
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.
|
Placebo + NRT Patch (Placebo)
n=41 Participants
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.
|
|---|---|---|---|---|
|
Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Baseline 2-Back RT
|
634.04 mili seconds
Standard Deviation 166.51
|
645.01 mili seconds
Standard Deviation 180.83
|
632.80 mili seconds
Standard Deviation 176.78
|
616.33 mili seconds
Standard Deviation 186.83
|
|
Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Baseline 3-Back RT
|
667.75 mili seconds
Standard Deviation 202.35
|
642.89 mili seconds
Standard Deviation 182.20
|
620.55 mili seconds
Standard Deviation 210.04
|
600.78 mili seconds
Standard Deviation 179.64
|
|
Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Week 1 2-Back RT
|
578.58 mili seconds
Standard Deviation 101.86
|
619.42 mili seconds
Standard Deviation 174.86
|
565.84 mili seconds
Standard Deviation 148.24
|
553.90 mili seconds
Standard Deviation 135.00
|
|
Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Week 1 3-Back RT
|
635.08 mili seconds
Standard Deviation 164.16
|
627.85 mili seconds
Standard Deviation 180.06
|
608.94 mili seconds
Standard Deviation 152.38
|
586.15 mili seconds
Standard Deviation 173.28
|
|
Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Week 12 2-Back RT
|
608.03 mili seconds
Standard Deviation 145.92
|
620.28 mili seconds
Standard Deviation 175.61
|
598.47 mili seconds
Standard Deviation 156.28
|
565.41 mili seconds
Standard Deviation 149.08
|
|
Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time
Week 12 3-Back RT
|
639.51 mili seconds
Standard Deviation 175.91
|
613.75 mili seconds
Standard Deviation 176.40
|
611.85 mili seconds
Standard Deviation 185.75
|
585.15 mili seconds
Standard Deviation 177.86
|
Adverse Events
EVP-6124 + NicoDerm (Active)
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
EVP-6124 + NRT Patch (Placebo)
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo + NicoDerm (Active)
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo + NRT Patch (Placebo)
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVP-6124 + NicoDerm (Active)
n=40 participants at risk
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)
n=41 participants at risk
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)
n=38 participants at risk
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)
n=41 participants at risk
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.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
1/40 • Number of events 1 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
2.6%
1/38 • Number of events 1 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
|
Gastrointestinal disorders
Diverticulitis Flare
|
0.00%
0/40 • week 1 to week 12
|
2.4%
1/41 • Number of events 1 • week 1 to week 12
|
0.00%
0/38 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
Other adverse events
| Measure |
EVP-6124 + NicoDerm (Active)
n=40 participants at risk
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)
n=41 participants at risk
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)
n=38 participants at risk
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)
n=41 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
27.5%
11/40 • Number of events 11 • week 1 to week 12
|
19.5%
8/41 • Number of events 8 • week 1 to week 12
|
21.1%
8/38 • Number of events 8 • week 1 to week 12
|
12.2%
5/41 • Number of events 5 • week 1 to week 12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
25.0%
10/40 • Number of events 10 • week 1 to week 12
|
9.8%
4/41 • Number of events 4 • week 1 to week 12
|
18.4%
7/38 • Number of events 7 • week 1 to week 12
|
17.1%
7/41 • week 1 to week 12
|
|
General disorders
Elevated Creatine phosphokinase (CPK)
|
5.0%
2/40 • Number of events 2 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
10.5%
4/38 • Number of events 4 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
|
Psychiatric disorders
Depressive symptoms
|
5.0%
2/40 • Number of events 2 • week 1 to week 12
|
2.4%
1/41 • Number of events 1 • week 1 to week 12
|
0.00%
0/38 • week 1 to week 12
|
9.8%
4/41 • Number of events 4 • week 1 to week 12
|
|
General disorders
Headache
|
25.0%
10/40 • Number of events 10 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
5.3%
2/38 • Number of events 2 • week 1 to week 12
|
9.8%
4/41 • Number of events 4 • week 1 to week 12
|
|
Infections and infestations
Cold/flu
|
17.5%
7/40 • Number of events 7 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
18.4%
7/38 • Number of events 7 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
|
Skin and subcutaneous tissue disorders
Skin Irritation at Patch Site
|
30.0%
12/40 • Number of events 12 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
5.3%
2/38 • Number of events 2 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
|
General disorders
Fatigue
|
12.5%
5/40 • Number of events 5 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
5.3%
2/38 • Number of events 2 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
|
General disorders
Insomnia
|
15.0%
6/40 • Number of events 6 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
15.8%
6/38 • Number of events 6 • week 1 to week 12
|
12.2%
5/41 • Number of events 5 • week 1 to week 12
|
|
Gastrointestinal disorders
Stomach pain
|
7.5%
3/40 • Number of events 3 • week 1 to week 12
|
12.2%
5/41 • Number of events 5 • week 1 to week 12
|
0.00%
0/38 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
|
General disorders
Nausea
|
7.5%
3/40 • Number of events 3 • week 1 to week 12
|
2.4%
1/41 • Number of events 1 • week 1 to week 12
|
7.9%
3/38 • Number of events 3 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Number of events 2 • week 1 to week 12
|
9.8%
4/41 • Number of events 4 • week 1 to week 12
|
2.6%
1/38 • Number of events 1 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
|
General disorders
weight gain
|
5.0%
2/40 • Number of events 2 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
2.6%
1/38 • Number of events 1 • week 1 to week 12
|
0.00%
0/41 • week 1 to week 12
|
|
General disorders
Irritability
|
10.0%
4/40 • Number of events 4 • week 1 to week 12
|
2.4%
1/41 • Number of events 1 • week 1 to week 12
|
2.6%
1/38 • Number of events 1 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
|
General disorders
Increase appetite
|
2.5%
1/40 • Number of events 1 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
2.6%
1/38 • Number of events 1 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
17.5%
7/40 • Number of events 7 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
0.00%
0/38 • week 1 to week 12
|
2.4%
1/41 • Number of events 1 • week 1 to week 12
|
|
General disorders
Allergies
|
15.0%
6/40 • Number of events 6 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
7.9%
3/38 • Number of events 3 • week 1 to week 12
|
7.3%
3/41 • Number of events 3 • week 1 to week 12
|
|
General disorders
Abnormal sleeping pattern
|
12.5%
5/40 • Number of events 5 • week 1 to week 12
|
2.4%
1/41 • Number of events 1 • week 1 to week 12
|
13.2%
5/38 • Number of events 5 • week 1 to week 12
|
4.9%
2/41 • Number of events 2 • week 1 to week 12
|
Additional Information
A. Eden Evins, MD, MPH
Massachusetts General Hospital-Center for Addiction Medicine
Phone: 617-643-4679
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place