Smoking CessationPhase 4NCT01010477
Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
A Phase 4 study testing Nicotine Nasal Spray and Behavioral counseling in people with Smoking Cessation and Schizophrenia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Schizophrenia
- What is being tested?
- Nicotine Nasal Spray and Behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be invited to participate in the study if they fulfill the following inclusion criteria:
- Meet DSM-IV diagnostic criteria for Schizophrenia
- Be 18 years of age or older
- Be daily smokers of 10 or more cigarettes per day (cpd)
- Have an expired CO level > 9 ppm
- Be motivated to quit smoking
Show all 9Show fewer
- Be willing to adhere to the study protocol (e.g. provide samples, attend all visits)
- Be able to give informed consent
- Stable on their current atypical antipsychotic medication for at least one month.
Who cannot join
- Subjects will be excluded based on any one of the following exclusion criteria:
- Current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days,
- Psychiatric hospitalization in the last 30 days
- Inability to read or understand the questionnaires in English
- Current pregnancy or lactation or plans to become pregnant in the next 12 months
- Regular use of non-cigarette forms of tobacco including cigars, pipes, smokeless tobacco
- Patients with significant cognitive impairment that may interfere with their study participation assessed as a Folstein Mini-Mental Status exam score of less than 22.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: Double-Blind, Placebo-Controlled Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.
- Conditions
- Smoking Cessation, Schizophrenia
- Being tested
- Nicotine Nasal Spray, Behavioral counseling
- Keywords
- smoking cessation, schizophrenia, nicotine nasal spray, behavioral counseling
- Medical subject headings
- Smoking Cessation, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Nasal SprayDrug
Also called Nicotrol
minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day
Behavioral counselingBehavioural
Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Nasal Spray | Experimental | Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. . Nasal spray will be used from the TQD through the end of Week 20. Receives: Drug: Nicotine Nasal Spray; Behavioral: Behavioral counseling |
| Placebo nasal spray | Placebo comparator | Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Nasal spray will be used from the TQD through the end of Week 20. Receives: Drug: Nicotine Nasal Spray; Behavioral: Behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects Who Quit Smoking From Weeks 5 to 8
Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2012
- Study completionAug 2012
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.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jill M Williams, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010477
- Sponsor's protocol ID
- 1R01DA024640-01A1
- Other IDs
- 1R01DA024640-01A1
- Status last verified
- Sep 2014
- First submitted
- 6 Nov 2009
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
- ClinicalTrials.gov ID
- NCT01010477
- Acronym / sponsor ID
- 1R01DA024640-01A1
- Conditions
- Smoking Cessation, Schizophrenia
- Keywords
- smoking cessation, schizophrenia, nicotine nasal spray, behavioral counseling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Nasal Spray | Experimental | Drug: Nicotine Nasal Spray, Behavioral: Behavioral counselingSubjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. . Nasal spray will be used from the TQD through the end of Week 20. |
| Placebo nasal spray | Placebo comparator | Drug: Nicotine Nasal Spray, Behavioral: Behavioral counselingSubjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Nasal spray will be used from the TQD through the end of Week 20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects will be invited to participate in the study if they fulfill the following inclusion criteria:
Key exclusion criteria (7 listed)
- Subjects will be excluded based on any one of the following exclusion criteria:
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 |
|---|---|---|
| Nicotine Nasal SprayAlso: Nicotrolminimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day | Drug | Nicotine Nasal Spray, Placebo nasal spray |
| Behavioral counselingBoth groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks. | Behavioural | Nicotine Nasal Spray, Placebo nasal spray |
Primary outcome
The Number of Subjects Who Quit Smoking From Weeks 5 to 8
Time frame: 4 weeks
Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- 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.
Jill M Williams, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Nasal Spray and Behavioral counseling in people with Smoking Cessation and Schizophrenia, run by Rutgers, The State University of New Jersey 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 9 inclusion and 7 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 8 Sep 2014. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 8 Sep 2014). 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?
The Number of Subjects Who Quit Smoking From Weeks 5 to 8 (time frame: 4 weeks). 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 8 Sep 2014.