Trial Outcomes & Findings for Test of Novel Drug for Smoking Cessation (NCT NCT02217527)
NCT ID: NCT02217527
Last Updated: 2018-08-15
Results Overview
Complete abstinence from smoking for 24 hr is counted as a "quit day" and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo. This same Mon-Fri procedure for one week (only) is done for both drug phases. Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
up to one week each drug phase (0-5)
Results posted on
2018-08-15
Participant Flow
All enrolled after confirmation of eligibility were then assigned to Order 1 or Order 2.
Participant milestones
| Measure |
Order 1--JNJ Active Then Plac
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, followed by trying to quit for one week on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Order 2--Placebo Then JNJ Active
Placebo pill used for one week quit attempt, as part of crossover design, followed by one week of trying to quit on active JNJ drug.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|---|---|---|
|
Drug Condition 1: First Study Phase
STARTED
|
18
|
18
|
|
Drug Condition 1: First Study Phase
COMPLETED
|
17
|
15
|
|
Drug Condition 1: First Study Phase
NOT COMPLETED
|
1
|
3
|
|
Drug Condition 2: Second Study Phase
STARTED
|
17
|
15
|
|
Drug Condition 2: Second Study Phase
COMPLETED
|
17
|
14
|
|
Drug Condition 2: Second Study Phase
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Order 1--JNJ Active Then Plac
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, followed by trying to quit for one week on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Order 2--Placebo Then JNJ Active
Placebo pill used for one week quit attempt, as part of crossover design, followed by one week of trying to quit on active JNJ drug.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|---|---|---|
|
Drug Condition 1: First Study Phase
Withdrawal by Subject
|
1
|
3
|
|
Drug Condition 2: Second Study Phase
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Test of Novel Drug for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Order 1--JNJ Active Then Plac
n=18 Participants
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, then one week trying to quit on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Order 2--Placebo Then JNJ Active
n=18 Participants
Placebo pill used for one week quit attempt, as part of crossover design, then one week trying to quit on active JNJ drug.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Fagerstrom Test of Nicotine Dependence (FTND) scale score
|
4.9 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to one week each drug phase (0-5)Population: Smokers trying to quit each day during 5-day period on active JNJ, and then during 5-day period on placebo, in crossover design.
Complete abstinence from smoking for 24 hr is counted as a "quit day" and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo. This same Mon-Fri procedure for one week (only) is done for both drug phases. Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5).
Outcome measures
| Measure |
Order 1--JNJ Active Then Plac
n=17 Participants
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, then one week quitting on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Order 2--Placebo Then JNJ Active
n=14 Participants
Placebo pill used for one week quit attempt, as part of crossover design, then one week quitting on active JNJ drug.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|---|---|---|
|
Quit Status
on JNJ
|
0.5 number of days quit
Standard Deviation 1.3
|
0.2 number of days quit
Standard Deviation 0.6
|
|
Quit Status
on placebo
|
0.7 number of days quit
Standard Deviation 1.5
|
0.5 number of days quit
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: only on days quit while on JNJ or on placeboPopulation: Withdrawal severity on quit days for smokers interested in quitting soon, while attempting to quit briefly during one week on active JNJ or one week on placebo.
Severity of withdrawal symptoms will be assessed with standard self-report measure of Minnesota Nicotine Withdrawal Scale (MNWS) each quit day during one week only on active JNJ, and each quit day during one week on placebo. Ratings are made on 0-100 visual analog scale, with 0="not at all" to 100="very much", and are averaged to create a total score also ranging from 0-100. Higher scores indicate more severe withdrawal.
Outcome measures
| Measure |
Order 1--JNJ Active Then Plac
n=17 Participants
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, then one week quitting on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Order 2--Placebo Then JNJ Active
n=14 Participants
Placebo pill used for one week quit attempt, as part of crossover design, then one week quitting on active JNJ drug.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|---|---|---|
|
Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo
on active JNJ
|
12.4 units on a scale
Standard Deviation 8.1
|
24.0 units on a scale
Standard Deviation 23.4
|
|
Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo
on placebo
|
15.5 units on a scale
Standard Deviation 15.2
|
23.1 units on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: first day during quit week on JNJ, and during quit week on placebo.Population: Only those participants able to quit or sharply limit smoking exposure during both JNJ and the placebo phases of testing, defined as those with CO\<10 during both tests of cognitive performance when tobacco abstinent.
This measure of cognitive performance (mean of median speed of correct responding on computer keyboard to letters and numbers) was assessed only on Monday (day 1) of the 0-5 days during each drug/placebo condition. Data only from those shown to have CO\<10 ppm were analyzed, to confirm responding during abstinence while on drug/placebo condition. Cognitive testing consisted of standard Continuous Performance Task (CPT), on active JNJ and on placebo phases. This measure is assessed to determine potential mechanism of drug efficacy in relieving disrupted cognitive processing function caused by tobacco deprivation and withdrawal.
Outcome measures
| Measure |
Order 1--JNJ Active Then Plac
n=6 Participants
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, then one week quitting on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Order 2--Placebo Then JNJ Active
n=6 Participants
Placebo pill used for one week quit attempt, as part of crossover design, then one week quitting on active JNJ drug.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
Placebo pill: Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|---|---|---|
|
Cognitive Function on Continuous Performance Task (CPT) for Those With CO<10 During First Assessment Day (Mon) of Attempt to Quit Smoking During Both JNJ and Plac Quit Periods
on active JNJ
|
444.3 ms time of correct responding
Standard Deviation 69.3
|
443.3 ms time of correct responding
Standard Deviation 32.0
|
|
Cognitive Function on Continuous Performance Task (CPT) for Those With CO<10 During First Assessment Day (Mon) of Attempt to Quit Smoking During Both JNJ and Plac Quit Periods
on placebo
|
434.2 ms time of correct responding
Standard Deviation 33.5
|
439.2 ms time of correct responding
Standard Deviation 28.0
|
Adverse Events
While on Active JNJ
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
While on Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
While on Active JNJ
n=36 participants at risk
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design, followed by one week of quitting on placebo. This JNJ experimental compound has NO name, just a company number.
Active JNJ Drug: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
|
While on Placebo
n=36 participants at risk
Placebo pill used for one week quit attempt, as part of crossover design, followed by one week of quitting on active JNJ drug.
Placebo pill: Placebo pill taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|---|---|---|
|
Gastrointestinal disorders
self-reported nausea
|
8.3%
3/36 • Number of events 3 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
Cardiac disorders
Abnormal EKG
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
Gastrointestinal disorders
diarrhea
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
Skin and subcutaneous tissue disorders
self-reported skin rash
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
Musculoskeletal and connective tissue disorders
swelling in feet
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
General disorders
body aches
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
General disorders
feeling of subjective panic
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
|
Cardiac disorders
heart racing
|
0.00%
0/36 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
2.8%
1/36 • Number of events 1 • Assessed over the 2 weeks of med use on each condition (active JNJ, or placebo) per participant and ending within 1 week post-participation.
Participants were asked about any adverse effects during each visit. If they reported any, study staff probed for details and contacted study physician who oversaw physical exam at screening to discuss next steps - e.g. monitor and further follow up visits until resolved, or refer to other medical specialists, or to WPIC laboratory for further testing until resolved. Participants also received lab tests via blood sample and EKG at one visit during each 2-week med use period.
|
Additional Information
Dr. Kenneth A. Perkins, Prof of Psychiatry
Univ of Pittsburgh
Phone: 412-246-5395
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place