Tobacco DependencePhase 2NCT02019459
Very Low Nicotine Cigarettes in Smokers With Schizophrenia
A Phase 2 study testing Very low nicotine content cigarettes and standard nicotine content cigarettes in people with Tobacco Dependence, run by Brown University at 1 site in United States.
Trial summary
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Very low nicotine content cigarettes and standard nicotine content cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2014to 31 Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Schizophrenia, schizoaffective disorder or bipolar disorder
- Smoke an average of at least 10 cigarettes per day for at least 1 year
- Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2)
Who cannot join
- Pregnant or nursing
- Seeking treatment for smoking
- Medical contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
- Conditions
- Tobacco Dependence
- Being tested
- Very low nicotine content cigarettes, standard nicotine content cigarettes
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low nicotine content cigarettesOther
standard nicotine content cigarettesOther
| Study group | Role | What they receive |
|---|---|---|
| 0.8 mg nicotine with 10.5 mg tar | Active comparator | SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition) Receives: Other: standard nicotine content cigarettes |
| 0.03 mg nicotine with 9 mg tar | Experimental | SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar Receives: Other: Very low nicotine content cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigarettes smoked per day
Measured: End of 6 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start17 Nov 2014
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh
- Responsible party
- Principal investigator, Jennifer Tidey, Brown University
- Investigators
- Jennifer Tidey, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019459
- Sponsor's protocol ID
- 5U54DA031659-03
- Status last verified
- Apr 2018
- First submitted
- 18 Dec 2013
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Low Nicotine Cigarettes in Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT02019459
- Acronym / sponsor ID
- 5U54DA031659-03
- Conditions
- Tobacco Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.8 mg nicotine with 10.5 mg tar | Active comparator | Other: standard nicotine content cigarettesSPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition) |
| 0.03 mg nicotine with 9 mg tar | Experimental | Other: Very low nicotine content cigarettesSPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70
- Schizophrenia, schizoaffective disorder or bipolar disorder
- Smoke an average of at least 10 cigarettes per day for at least 1 year
- Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2)
Key exclusion criteria (3 listed)
- Pregnant or nursing
- Seeking treatment for smoking
- Medical contraindications
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 |
|---|---|---|
| Very low nicotine content cigarettes | Other | 0.03 mg nicotine with 9 mg tar |
| standard nicotine content cigarettes | Other | 0.8 mg nicotine with 10.5 mg tar |
Primary outcome
Number of cigarettes smoked per day
Time frame: End of 6 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
Related trials for Tobacco Dependence
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
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.
Jennifer Tidey, Ph.D. principal investigator
Brown University
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 Very low nicotine content cigarettes and standard nicotine content cigarettes in people with Tobacco Dependence, run by Brown University 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 4 inclusion and 3 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 9 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of cigarettes smoked per day (time frame: End of 6 week intervention). 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 9 Apr 2018.