Smoking CessationPhase 2TRENDSNCT02230384
Novel Smoking Cessation Drug for Schizophrenia
A Phase 2 study testing Active JNJ Drug in people with Smoking Cessation, run by K.N. Roy Chengappa at 1 site in United States.
Trial summary
The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Active JNJ Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 9 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Smoking/Nicotine Exclusions:
- Use of smokeless tobacco or snuff or chewing tobacco
- Use of e-cigarettes, or any non-tobacco nicotine products (e.g. nicotine gum, lozenges, patch, etc.)
- Current enrollment or plans to enroll in another smoking cessation program. (Bupropion use for depression will be assessed on a case by case basis)
- Alcohol/Illicit Substance Exclusion Criteria:
- Recent alcohol or substance dependence (≤ 3 months)
Show all 21Show fewer
- Current alcohol consumption that exceeds 15 standard drinks/week or greater than 2 standard drinks daily
- Medical Exclusion Criteria:
- Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
- Serious or unstable medical disorder within the past 3 months (assessed by the investigators)
- Epilepsy
- Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
- Evidence impaired liver function test (LFT) defined as serum glutamate oxaloacetate transaminase (SGOT) (AST) or serum glutamate pyruvate transaminase (SGPT) (ALT) or alkaline phosphatase greater than 1x the upper limit of normal, or bilirubin 1x the upper limit of normal
- Evidence of kidney failure defined as: Serum creatinine > 1.8 mg/dl for males and 1.6 mg/dl for females.
- Any subject with a history of hematological cancers examples: leukemia, lymphoma etc. will be excluded.
- Any clinically significant hematological laboratory abnormality (chronic low-grade laboratory values just above or below the reference range that are without clinical significance will be permitted) will be grounds for exclusion.
- Medication Exclusion Criteria:
- Current use or recent discontinuation (within last 14-days) of the following medications: any form of smoking cessation medication (Bupropion except when used for Depressive Disorders on a case by case basis, Varenicline, NRT); and (b) opiate-containing medications for chronic pain. Potent CYP 3A4 inhibitors will be reviewed for exclusion, see below.
- In view of novel drug being a moderate CYP3A4 inhibitor, any subjects receiving the following narrow therapeutic index CYP3A4 substrates will be excluded: Alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine.
- In view of the impact of clozapine on smoking cessation, patients receiving clozapine will be excluded.
- Stable medical conditions examples: hypertension, diabetes, dyslipidemia etc that are treated and ongoing and patients are not receiving the exclusionary drugs noted above will be considered for inclusion on a case by case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic and affilated sites
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Development of of A Novel Therapeutic to Aid Tobacco Smoking Cessation in Persons With Schizophrenia or Schizoaffective Disorder
The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. The investigators predict that the novel drug will increase days of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking cessation in smokers with schizophrenia.
The investigators will also assess if this new drug decreases nicotine withdrawal, craving, and cognitive impairment during early abstinence, as well as evaluate adverse effects.
Read the detailed description
Objective:
This is a Proof of Concept study planned over nearly 2 years to determine the potential efficacy of a novel drug for smokers with schizophrenia.
This study will assess 60 smokers with a diagnosis of either schizophrenia or schizoaffective disorder with high quit interest on their ability to quit during a week-long attempt to abstain while receiving a novel drug vs. placebo, using a within-subjects cross-over design.
Research Plan:
Active drug or placebo will be provided to participants in double-blind fashion.
Study participation will last 6 weeks after subjects enter the study following the screening and physical exam sessions (about 8 weeks total). Participants will engage in two identical study phases, each involving visits over 3 weeks and varying only in whether active drug or placebo is administered. The 3 weeks will involve: baseline visits, dose run-up (week 2), and week 3 (for abstinence assessments). The first week of each period will be a baseline week in which they smoke normally without any medication. During week 2, subjects will begin the dose run-up of active drug or placebo, increasing over 4 days from 1 tablet of 50 mg once daily to 100 mg b.i.d. (two 50 mg tablets twice/day), which will continue through the second and third weeks. Active drug or placebo will be administered in counter-balanced order in a cross-over design. During week 3, subjects will be instructed to try to abstain on each day, i.e. Mon-Friday. Most visits will last 60 mins and involve psychiatric assessments (including psychopathology and neurological and other side effects) ratings, providing an expired breath carbon monoxide (CO) measure that assesses smoking exposure in the past 24 hrs, as well as completing brief self-report measures of craving, withdrawal, and mood. On week 3 of each phase, one visit will involve cognitive testing. On Fri of week 3, subjects will discontinue all medication and resume ad lib smoking prior to the next study period, involving the same 3-week procedure (but with the other medication condition): baseline, dose run-up, full dose administration plus abstinence assessment. Note that active medication will be taken during only one period, with placebo taken during the other period. Pill counts will be used to measure adherence.
Primary and secondary dependent measures are described separately in this report.
Psychopathology will be assessed using standard rating scales to evaluate psychoses and general psychopathology and severity of illness ratings, and suicide rating scales. These and clinical impressions of patients in the study will assist in monitoring for stability or worsening of psychoses or suicidal behavior and/or the need to exit patients from the study.
Laboratory and EKG monitoring at the beginning and end of the study will also be part of the subject safety procedures.
Patients will be offered their choice of one of the FDA approved smoking cessation agents, i.e. nicotine replacement therapy, bupropion or varenicline for a 3-month period upon completion of the study. If patients decline open-label smoking cessation participation, they will be requested to come in for one post-study visit, 14 ± 4 days later. At the first post-study visit, if there are no adverse events, their participation will end.
Methods:
The novel drug or placebo will be administered double-blind in counter-balanced order in a cross-over design. This is not a clinical trial that assesses long term smoking cessation but a within-subjects comparison of the short-term effects of this drug on abstinence and abstinence symptoms over a week-long period, relative to placebo.
Significance:
This study addresses an important question of whether the novel drug shows potential efficacy for smoking cessation, relative to placebo, in smokers with schizophrenia. This procedure could have enormous implications for accelerating the development of this medication and similar compounds to help people quit smoking by increasing the efficiency of early medication evaluation.
- Conditions
- Smoking Cessation
- Being tested
- Active JNJ Drug, Placebo Pill
- Keywords
- Attempt at Smoking Cessation, Schizophrenia or Schizoaffective disorder, Novel nicotinergic drug
- Medical subject headings
- Smoking Cessation, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active JNJ DrugDrug
Also called JNJ-39393406
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 PillDrug
Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week
| Study group | Role | What they receive |
|---|---|---|
| Active JNJ 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. Receives: Drug: Active JNJ Drug; Drug: Placebo Pill |
| Placebo Pill | Experimental | Placebo pill used for one week quit attempt, as part of crossover design. Receives: Drug: Active JNJ Drug; Drug: Placebo Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Status
Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week)
Numbers reported are collapsed across medication conditions for each medication order.
Measured: Daily - Mon-Fri during the quit week in each phase
Secondary outcomes (6)
Withdrawal When Quit
Severity of withdrawal symptoms will be assessed with standard self-report measures each day during the quit week only of each phase. Data will be analysed when quit criteria were met. Scale used was the Minnesota Nicotine Withdrawal Scale (MNWS), ranging from 0 to 100, with higher scores indicating greater levels of withdrawal symptoms. The MNWS was completed 5 times for each participant during the quit week of each phase. The mean score was used to aggregate across visits.
Measured: during each quit week
Cognitive Functions
Performance on standardized cognitive tasks (Continuous Performance Task) to determine potential mechanisms of drug efficacy when CO < 10 smoking reduction criteria was met for both sessions. The Continuous Performance Test provides assesses sustained attention in milliseconds.
Measured: Assessed at the end of both treatment phases, i.e., at the end of 3 and 6 weeks.
Monitoring of Psychiatric Symptoms Including Psychopathology
Psychiatric symptoms using Positive and Negative Syndrome Scale (PANSS) will be conducted at each visit in each 3 week phase of the study
PANSS - Positive and Negative Syndrome Scale. Min value 30, Max value 210, higher scores are worse outcome.
The mean score was used to aggregate across visits.
Measured: Once at every scheduled visit
Number of Participants That Met Criteria for Treatment Emergent Suicidal Ideation or Behavior
CSSRS: Columbia Suicide Severity rating Scale. The scale assesses treatment emergent suicidal ideation and/or behavior categorically as a YES/NO response (no min/max score). "No" responses indicate ideation/behaviors did not emerge "Yes" responses indicate there were ideation or behaviors We are reporting the number of participants that met criteria for suicidal ideation or behavior, based on their CSSRS assessment
Measured: Every visit up to six weeks. It is only significant when there is a positive response "Yes"
Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results
Routine safety labs (included liver and renal labs) were done at baseline, Visit 9, and Visit 18 to determine whether there were treatment emergent clinically significant changes in any of the laboratory parameters. (no subject with abnormal labs at baseline were enrolled in the study) In addition, liver and renal labs were drawn at Visit 4 and Visit 13 to assess for treatment emergent, clinically significant abnormal liver and renal functions.
The reported results in the data table below show the number of subjects that had treatment emergent clinically significant abnormal lab results at any of the time points.
If labs were not within the normal range, they were reviewed by the physician investigators to determine whether they were clinically significant.
Measured: Weeks 0, 2, 3, 5, 6
The Number of Participants Who Had Treatment Emergent Clinically Significant EKG Results
EKG measures were done at the screening visit and at the end of study to determine whether there were treatment emergent clinically significant changes in the EKG parameters.
No subjects with abnormal EKGs at baseline were enrolled in the study The data table below shows the number of subjects with clinically significant abnormal EKG results at the end of the study.
Measured: Baseline (Week 0) and end of study (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion16 Dec 2016
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- K.N. Roy Chengappa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, National Institutes of Health (NIH), Virginia Commonwealth University
- Responsible party
- Sponsor-investigator, K.N. Roy Chengappa, University of Pittsburgh
- Investigators
- K.N. Roy Chengappa, MD, Principal investigator, Western Psychiatric Institute and Clinic - UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230384
- Sponsor's protocol ID
- PRO14060338
- Other IDs
- UH3TR000958
- Acronym
- TRENDS
- Status last verified
- Mar 2019
- First submitted
- 24 Jul 2014
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of of A Novel Therapeutic to Aid Tobacco Smoking Cessation in Persons With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02230384
- Acronym / sponsor ID
- TRENDS / PRO14060338
- Conditions
- Smoking Cessation
- Keywords
- Attempt at Smoking Cessation, Schizophrenia or Schizoaffective disorder, Novel nicotinergic drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- K.N. Roy ChengappaUniversity, hospital or other
- Collaborators
- University of Pittsburgh, National Institutes of Health (NIH), Virginia Commonwealth University
- Study start
- Sep 2014 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. The investigators predict that the novel drug will increase days of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking cessation in smokers with schizophrenia.
The investigators will also assess if this new drug decreases nicotine withdrawal, craving, and cognitive impairment during early abstinence, as well as evaluate adverse effects.
Detailed description
Objective:
This is a Proof of Concept study planned over nearly 2 years to determine the potential efficacy of a novel drug for smokers with schizophrenia.
This study will assess 60 smokers with a diagnosis of either schizophrenia or schizoaffective disorder with high quit interest on their ability to quit during a week-long attempt to abstain while receiving a novel drug vs. placebo, using a within-subjects cross-over design.
Research Plan:
Active drug or placebo will be provided to participants in double-blind fashion.
Study participation will last 6 weeks after subjects enter the study following the screening and physical exam sessions (about 8 weeks total). Participants will engage in two identical study phases, each involving visits over 3 weeks and varying only in whether active drug or placebo is administered. The 3 weeks will involve: baseline visits, dose run-up (week 2), and week 3 (for abstinence assessments). The first week of each period will be a baseline week in which they smoke normally without any medication. During week 2, subjects will begin the dose run-up of active drug or placebo, increasing over 4 days from 1 tablet of 50 mg once daily to 100 mg b.i.d. (two 50 mg tablets twice/day), which will continue through the second and third weeks. Active drug or placebo will be administered in counter-balanced order in a cross-over design. During week 3, subjects will be instructed to try to abstain on each day, i.e. Mon-Friday. Most visits will last 60 mins and involve psychiatric assessments (including psychopathology and neurological and other side effects) ratings, providing an expired breath carbon monoxide (CO) measure that assesses smoking exposure in the past 24 hrs, as well as completing brief self-report measures of craving, withdrawal, and mood. On week 3 of each phase, one visit will involve cognitive testing. On Fri of week 3, subjects will discontinue all medication and resume ad lib smoking prior to the next study period, involving the same 3-week procedure (but with the other medication condition): baseline, dose run-up, full dose administration plus abstinence assessment. Note that active medication will be taken during only one period, with placebo taken during the other period. Pill counts will be used to measure adherence.
Primary and secondary dependent measures are described separately in this report.
Psychopathology will be assessed using standard rating scales to evaluate psychoses and general psychopathology and severity of illness ratings, and suicide rating scales. These and clinical impressions of patients in the study will assist in monitoring for stability or worsening of psychoses or suicidal behavior and/or the need to exit patients from the study.
Laboratory and EKG monitoring at the beginning and end of the study will also be part of the subject safety procedures.
Patients will be offered their choice of one of the FDA approved smoking cessation agents, i.e. nicotine replacement therapy, bupropion or varenicline for a 3-month period upon completion of the study. If patients decline open-label smoking cessation participation, they will be requested to come in for one post-study visit, 14 ± 4 days later. At the first post-study visit, if there are no adverse events, their participation will end.
Methods:
The novel drug or placebo will be administered double-blind in counter-balanced order in a cross-over design. This is not a clinical trial that assesses long term smoking cessation but a within-subjects comparison of the short-term effects of this drug on abstinence and abstinence symptoms over a week-long period, relative to placebo.
Significance:
This study addresses an important question of whether the novel drug shows potential efficacy for smoking cessation, relative to placebo, in smokers with schizophrenia. This procedure could have enormous implications for accelerating the development of this medication and similar compounds to help people quit smoking by increasing the efficiency of early medication evaluation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active JNJ Drug | Experimental | Drug: Active JNJ Drug, Drug: Placebo Pill200 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. |
| Placebo Pill | Experimental | Drug: Active JNJ Drug, Drug: Placebo PillPlacebo pill used for one week quit attempt, as part of crossover design. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Use of smokeless tobacco or snuff or chewing tobacco
- Use of e-cigarettes, or any non-tobacco nicotine products (e.g. nicotine gum, lozenges, patch, etc.)
- Current enrollment or plans to enroll in another smoking cessation program. (Bupropion use for depression will be assessed on a case by case basis)
- Recent alcohol or substance dependence (≤ 3 months)
- Current alcohol consumption that exceeds 15 standard drinks/week or greater than 2 standard drinks daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active JNJ DrugAlso: JNJ-39393406200 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 | Drug | Active JNJ Drug, Placebo Pill |
| Placebo PillPlacebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week | Drug | Active JNJ Drug, Placebo Pill |
Primary outcome
Quit Status
Time frame: Daily - Mon-Fri during the quit week in each phase
Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week) Numbers reported are collapsed across medication conditions for each medication order.
6 secondary outcomes
Withdrawal When Quit
Time frame: during each quit week
Cognitive Functions
Time frame: Assessed at the end of both treatment phases, i.e., at the end of 3 and 6 weeks.
Monitoring of Psychiatric Symptoms Including Psychopathology
Time frame: Once at every scheduled visit
Number of Participants That Met Criteria for Treatment Emergent Suicidal Ideation or Behavior
Time frame: Every visit up to six weeks. It is only significant when there is a positive response "Yes"
Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results
Time frame: Weeks 0, 2, 3, 5, 6
The Number of Participants Who Had Treatment Emergent Clinically Significant EKG Results
Time frame: Baseline (Week 0) and end of study (week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K.N. Roy Chengappa, MD principal investigator
Western Psychiatric Institute and Clinic - UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active JNJ Drug in people with Smoking Cessation, run by K.N. Roy Chengappa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit Status (time frame: Daily - Mon-Fri during the quit week in each phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.