Smoking CessationPhase 4NCT02676375
Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
A Phase 4 study testing Combination Bupropion + NRTs, Extended Treatment and Home Visits & Calls in people with Smoking Cessation and Schizophrenia, run by Brentwood Biomedical Research Institute at 1 site in United States.
Trial summary
The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Schizophrenia
- What is being tested?
- Combination Bupropion + NRTs, Extended Treatment and Home Visits & Calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans 21 years of age or older;
- meet DSM-IV criteria for Schizophrenia or Schizoaffective disorder based on clinical interview
- meet DSM-IV criteria for nicotine dependence
- must report smoking >10 cigarettes daily and positive CO exhalation >8ppm
- seeking treatment for nicotine dependence;
- willing and able to comply with study procedures;
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- willing and able to provide written informed consent;
- if female, not pregnant or lactating and willing to use a medically reliable method of birth control during the trial (e.g., birth control pills, Depo-Provera, and/or condoms with spermicide).
- Must be clinically stable (i.e., no inpatient hospitalizations for 3 months prior to enrollment, no changes in medication in the four weeks prior to enrollment)
Who cannot join
- current or past history of cardiovascular disease including myocardial infarction, acute coronary syndrome, angina pectoris, coronary artery disease, atrial fibrillation/flutter, cor pulmonale, arrhythmia other than sinus tachycardia or sinus bradycardia, or an EKG suggesting any of these;
- systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension)
- a history of angioedema;
- renal impairment (CrCl < 50);
- a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make study agent compliance difficult or which would compromise informed consent;
- a history of attempted suicide (lifetime) and/or suicidal ideation in the past year as assessed by the C-SSRS;
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- currently on prescription medication that is contraindicated for use with bupropion;
- currently using any form of nicotine replacement therapy;
- current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV within the past 6 months;
- a history of sensitivity to bupropion or nicotine replacement;
- any history of seizures or seizure disorder;
- a history of serious head injury (ie, loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury
- evidence of substance or alcohol dependence in the past six months; evidence of substance or alcohol abuse in the past month;
- sedatives or benzodiazepine use within 12 hours of testing based on urine toxicology screening
- history of mental retardation or developmental disability based on chart review
- psychiatric hospitalization during study participation
- history of an eating disorder
- have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
- have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
- have a known allergy to nicotine or any component of the nicotine patches
- be pregnant or sexually active and not using reliable birth control methods consistently (for females)
Trial locations and contacts
1 site in 1 country.
United States1 site
West Los Angeles Veterans Affairs Medical Center
Los Angeles, California, 90073
About this study
The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.
- Conditions
- Smoking Cessation, Schizophrenia
- Being tested
- Combination Bupropion + NRTs, Extended Treatment, Home Visits & Calls, Monotherapy
- 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.
Combination Bupropion + NRTsDrug
Extended TreatmentOther
Home Visits & CallsOther
MonotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard Monotherapy | Other | Treatment as usual starting with one smoking cessation medication plus group therapy. Receives: Drug: Monotherapy |
| Combination Extended Treatment | Experimental | Extended treatment with multiple standard medications plus group therapy. Receives: Drug: Combination Bupropion + NRTs; Other: Extended Treatment |
| Combination Extended Treatment + Home Visits/Calls | Experimental | Extended treatment with multiple standard medications plus group therapy plus home visits. Receives: Drug: Combination Bupropion + NRTs; Other: Extended Treatment; Other: Home Visits & Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)
Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).
Measured: Measured week 0, 12, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brentwood Biomedical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Brody, Brentwood Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676375
- Sponsor's protocol ID
- 0024
- Status last verified
- Jul 2019
- First submitted
- 4 Feb 2016
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
- ClinicalTrials.gov ID
- NCT02676375
- Acronym / sponsor ID
- 0024
- Conditions
- Smoking Cessation, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Brentwood Biomedical Research InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Monotherapy | Other | Drug: MonotherapyTreatment as usual starting with one smoking cessation medication plus group therapy. |
| Combination Extended Treatment | Experimental | Drug: Combination Bupropion + NRTs, Other: Extended TreatmentExtended treatment with multiple standard medications plus group therapy. |
| Combination Extended Treatment + Home Visits/Calls | Experimental | Drug: Combination Bupropion + NRTs, Other: Extended Treatment, Other: Home Visits & CallsExtended treatment with multiple standard medications plus group therapy plus home visits. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Veterans 21 years of age or older;
- meet DSM-IV criteria for Schizophrenia or Schizoaffective disorder based on clinical interview
- meet DSM-IV criteria for nicotine dependence
- must report smoking >10 cigarettes daily and positive CO exhalation >8ppm
- seeking treatment for nicotine dependence;
Key exclusion criteria (21 listed)
- current or past history of cardiovascular disease including myocardial infarction, acute coronary syndrome, angina pectoris, coronary artery disease, atrial fibrillation/flutter, cor pulmonale, arrhythmia other than sinus tachycardia or sinus bradycardia, or an EKG suggesting any of these;
- systolic blood pressure greater than 160 or diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension)
- a history of angioedema;
- renal impairment (CrCl < 50);
- a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make study agent compliance difficult or which would compromise informed consent;
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 |
|---|---|---|
| Combination Bupropion + NRTs | Drug | Combination Extended Treatment, Combination Extended Treatment + Home Visits/Calls |
| Extended Treatment | Other | Combination Extended Treatment, Combination Extended Treatment + Home Visits/Calls |
| Home Visits & Calls | Other | Combination Extended Treatment + Home Visits/Calls |
| Monotherapy | Drug | Standard Monotherapy |
Primary outcome
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)
Time frame: Measured week 0, 12, and 26
Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Combination Bupropion + NRTs, Extended Treatment and Home Visits & Calls in people with Smoking Cessation and Schizophrenia, run by Brentwood Biomedical Research Institute 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 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 30 Jul 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 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 30 Jul 2019). 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?
Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) (time frame: Measured week 0, 12, and 26). 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 30 Jul 2019.