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| ID | Type | Description | Link |
|---|---|---|---|
| UH3TR000958 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid cessation during a one-week "practice" quit period for each condition in smokers with a high interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.
We aim to test the proof of principal that an alpha-7 PAM drug, JNJ-39393406, promotes smoking cessation when compared to placebo. We have developed, tested, and validated an efficient Phase 2a screening procedure that optimally combines the validity of randomized clinical trials with the practicality of lab- based medication studies. Notably, it employs a within-subject, cross-over design comparing active versus placebo effects on quitting smoking to maximize statistical power without a large sample, in contrast to the large samples needed for between-groups randomized treatment conditions. Using this procedure, we will evaluate effects of JNJ-39393406 vs. placebo on short-term smoking abstinence in smokers who already have a high interest in quitting soon. We predict that, compared with placebo, JNJ-39393406 will increase days of abstinence, identifying initial evidence of efficacy for smoking cessation. Our main dependent measure is days of very stringent biochemically validated (expired CO<5 ppm) 24-hr smoking abstinence, with post-quit withdrawal and cognitive function as secondary measures. Potential for adverse side-effects will be assessed at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ Active Drug | Experimental | 200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number. |
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| Placebo Pill | Experimental | Placebo pill used for one week quit attempt, as part of crossover design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active JNJ Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quit Status | 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). | up to one week each drug phase (0-5) |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and 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. |
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Inclusion Criteria:
Healthy male and female dependent smokers wanting to quit soon
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Exclusion Criteria:
Use of non-smoked nicotine products
Already enrolled in cessation program.
Epilepsy
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Perkins, PhD | Univ of PIttsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
All enrolled after confirmation of eligibility were then assigned to Order 1 or Order 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Condition 1: First Study Phase |
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| Drug Condition 2: Second Study Phase |
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Healthy smokers interested in permanently quitting smoking within the next few months.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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, 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quit Status | 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). | Smokers trying to quit each day during 5-day period on active JNJ, and then during 5-day period on placebo, in crossover design. | Posted | Mean | Standard Deviation | number of days quit | up to one week each drug phase (0-5) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | While on Active JNJ | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| self-reported nausea | Gastrointestinal disorders | Systematic Assessment | Self-report of nausea |
Our findings could be specific to the brief duration, procedures used, and single dose tested in this cross-over study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth A. Perkins, Prof of Psychiatry | Univ of Pittsburgh | 412-246-5395 | perkinska@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2018 | Jun 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000630150 | JNJ-39393406 |
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Crossover of active JNJ vs. placebo for 2 weeks each, involving 1 week of dose run-up and 1 week of attempting to quit each day on that drug condition. A one-week washout separates these drug conditions, which are administered in counter-balanced order.
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| Placebo pill | Drug | Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week. |
|
| only on days quit while on JNJ or on placebo |
| 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 | 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. | first day during quit week on JNJ, and during quit week on placebo. |
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| BG001 | Order 2--Placebo Then JNJ Active | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fagerstrom Test of Nicotine Dependence (FTND) scale score | All completed the Fagerstrom Test of Nicotine Dependence (FTND) scale score at baseline, to assess severity of current nicotine dependence. FTND scores range from 0-10, and higher scores index more severe dependence. These scores were not used to determine eligibility, just to characterize dependence severity. | Mean | Standard Deviation | units on a scale |
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| OG001 | Order 2--Placebo Then JNJ Active | 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. |
|
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| Secondary | Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | only on days quit while on JNJ or on placebo |
|
|
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | ms time of correct responding | first day during quit week on JNJ, and during quit week on placebo. |
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| 0 |
| 36 |
| 0 |
| 36 |
| 5 |
| 36 |
| EG001 | While on Placebo | 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. | 0 | 36 | 0 | 36 | 3 | 36 |
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| Abnormal EKG | Cardiac disorders | Systematic Assessment | sinus bradycardia, incomplete right bundle branch QRS pattern |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment | Self-reported complaint of diahrrea |
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| self-reported skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin rash report |
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| swelling in feet | Musculoskeletal and connective tissue disorders | Systematic Assessment | swelling, numbness, and pain in feet while walking |
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| body aches | General disorders | Systematic Assessment | Self-reported body aches |
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| feeling of subjective panic | General disorders | Systematic Assessment | Shortness of breath, dizziness, overwhelming feeling |
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| heart racing | Cardiac disorders | Systematic Assessment | heart racing, sadness |
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