SchizophreniaPhase 4NCT03495024
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
A Phase 4 study testing Varenicline in people with Schizophrenia and Schizoaffective Disorder, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial summary
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Tobacco Smoking
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 30 Jun 2020
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease
- Glazer-Morgenstern-Doucette criteria for TD
- Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening
- An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening
- Agree to stop smoking by the target date (four weeks after baseline
- Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline
Who cannot join
- Have untreated or unstable acute medical or psychiatric illnesses
- Have a history of seizures
- History of somnambulism
- Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)
- Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen
- Are receiving clozapine or cholinesterase inhibitors
Show all 15Show fewer
- Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)
- Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period
- Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression/anxiety score ≥ 8 on the HADS.
- Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control
- Use of an investigational drug within 30 days of screening
- Use of other smoking cessation aids (bupropion, nicotine replacement products)
- Use of other tobacco products
- History of allergic reactions to varenicline
- Lack capacity to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corporal Michael J Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
Stanley N Caroff, MD, 215-823-4065, stanley.caroff@va.gov
Rosalind M Berkowitz, MD, 215-823-4065, rosalind.berkowitz@va.gov
About this study
Official title: Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
Read the detailed description
- Objectives(s): To study whether smoking cessation with varenicline treatment will be associated with a significant reduction in symptoms of antipsychotic-induced tardive dyskinesia without worsening acute extrapyramidal symptoms.
- Research Design: To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week exploratory, open-label, proof-of-concept, pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
- Methodology: Patients will be evaluated at a Screening Visit 1 (Week 0) and at a Baseline Visit 2 (Week 2) two weeks apart. After the Baseline Visit, subjects will be asked to cease smoking completely by the target date four weeks after the baseline visit (Week 6) and will attend a clinic Cessation Visit 4 (Week 6) for medication check and resupply. Treatment with varenicline will start at Baseline Visit 2 (Week 2) with 0.5mg hs x 3 days, 0.5mg bid x 4 days, then start 1mg bid at Visit 3 (Week 3) for the remaining 9 weeks of the study.
At the Screening and Baseline Visits, and at study visits thereafter (Visit 3-7), subjects will be evaluated for efficacy and safety, and changes in smoking or other tobacco use since the last visit. The following measures will be taken; Fagerstrom Test for Cigarette Dependence (FTCD) at screening only; Cigarette smoking will be assessed by a structured questionnaire of time-line follow-back (TLFB) usage; Expired carbon using a hand-held carbon monoxide monitor; Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS); Global Clinical Impression Scale (CGI-S at baseline, CGI-I at final visit) for TD; C-SSRS; Brief Psychiatric Rating Scale (BPRS), Mini-Mental Status Examination (MMSE) and Hospital Anxiety and Depression Scale (HADS) at baseline and the final visit only; Brief smoking cessation counseling; Laboratory measures; Urine toxicology sample at the screening and final visits only, serum pregnancy test (women) at screening visit only; Changes in psychotropic medications; Varenicline compliance by pill counts; Adverse events.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Tobacco Smoking, Tardive Dyskinesia, Parkinsonism
- Being tested
- Varenicline
- Keywords
- Schizophrenia, Schizoaffective disorder, Antipsychotics, Tobacco smoking, Tardive dyskinesia, Parkinsonism
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Tobacco Smoking, Tardive Dyskinesia, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called CHANTIX
Oral medication approved to facilitate smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation with varenicline | Other | FDA-approved indication of varenicline for smoking cessation Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 7-day point prevalence of abstinence prior to week 12
Self-reported 7-day point prevalence of abstinence prior to week 12
Measured: 12 weeks
Secondary outcomes (3)
A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
Measured: 12 weeks
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Measured: 12 weeks
Abstinence determined by 24-hour point prevalence at week 12
Abstinence determined by 24-hour point prevalence at week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Jan 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A 12 week exploratory, open-label, proof-of-concept, pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stanley N. Caroff, MD, Corporal Michael J. Crescenz VA Medical Center
- Investigators
- Stanley N Caroff, MD, Principal investigator, Cpl. Michael J. Crescenz VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495024
- Sponsor's protocol ID
- 01730
- Status last verified
- Mar 2019
- First submitted
- 4 Apr 2018
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final aggregate and pooled data analyses and results devoid of any individual identifying information will be summarized in abstract form for presentations and in a final manuscript for publication at the end of the one-year study period. Final data sets will be shared upon written request for public availability. Data sets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by VA ORD. Prior to distribution, a local privacy officer will certify that the data set contains no PHI
Publications
Caroff SN, Campbell EC, Carroll B. Pharmacological treatment of tardive dyskinesia: recent developments. Expert Rev Neurother. 2017 Sep;17(9):871-881. doi: 10.1080/14737175.2017.1358616. Epub 2017 Jul 31.
PubMed 28727483Caroff SN, Campbell EC. Drug-Induced Extrapyramidal Syndromes: Implications for Contemporary Practice. Psychiatr Clin North Am. 2016 Sep;39(3):391-411. doi: 10.1016/j.psc.2016.04.003. Epub 2016 Jun 23.
PubMed 27514296Caroff SN, Davis VG, Miller DD, Davis SM, Rosenheck RA, McEvoy JP, Campbell EC, Saltz BL, Riggio S, Chakos MH, Swartz MS, Keefe RS, Stroup TS, Lieberman JA; CATIE Investigators. Treatment outcomes of patients with tardive dyskinesia and chronic schizophrenia. J Clin Psychiatry. 2011 Mar;72(3):295-303. doi: 10.4088/JCP.09m05793yel. Epub 2010 Aug 10.
PubMed 20816031Caroff SN, Walker P, Campbell C, Lorry A, Petro C, Lynch K, Gallop R. Treatment of tardive dyskinesia with galantamine: a randomized controlled crossover trial. J Clin Psychiatry. 2007 Mar;68(3):410-5. doi: 10.4088/jcp.v68n0309.
PubMed 17388711Caroff SN, Martine R, Kleiner-Fisman G, Eisa M, Lorry A, Gallop R, Stern MB, Duda JE. Treatment of levodopa-induced dyskinesias with donepezil. Parkinsonism Relat Disord. 2006 May;12(4):261-3. doi: 10.1016/j.parkreldis.2005.10.003. Epub 2005 Dec 20. No abstract available.
PubMed 16364675Bordia T, Zhang D, Perez XA, Quik M. Striatal cholinergic interneurons and D2 receptor-expressing GABAergic medium spiny neurons regulate tardive dyskinesia. Exp Neurol. 2016 Dec;286:32-39. doi: 10.1016/j.expneurol.2016.09.009. Epub 2016 Sep 19.
PubMed 27658674Quik M, Bordia T, Zhang D, Perez XA. Nicotine and Nicotinic Receptor Drugs: Potential for Parkinson's Disease and Drug-Induced Movement Disorders. Int Rev Neurobiol. 2015;124:247-71. doi: 10.1016/bs.irn.2015.07.005. Epub 2015 Aug 18.
PubMed 26472532
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response
- ClinicalTrials.gov ID
- NCT03495024
- Acronym / sponsor ID
- 01730
- Conditions
- Schizophrenia, Schizoaffective Disorder, Tobacco Smoking, Tardive Dyskinesia, Parkinsonism
- Keywords
- Schizophrenia, Schizoaffective disorder, Antipsychotics, Tobacco smoking, Tardive dyskinesia, Parkinsonism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 11 Apr 2018 (actual)
- 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.
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
Detailed description
- Objectives(s): To study whether smoking cessation with varenicline treatment will be associated with a significant reduction in symptoms of antipsychotic-induced tardive dyskinesia without worsening acute extrapyramidal symptoms.
- Research Design: To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week exploratory, open-label, proof-of-concept, pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
- Methodology: Patients will be evaluated at a Screening Visit 1 (Week 0) and at a Baseline Visit 2 (Week 2) two weeks apart. After the Baseline Visit, subjects will be asked to cease smoking completely by the target date four weeks after the baseline visit (Week 6) and will attend a clinic Cessation Visit 4 (Week 6) for medication check and resupply. Treatment with varenicline will start at Baseline Visit 2 (Week 2) with 0.5mg hs x 3 days, 0.5mg bid x 4 days, then start 1mg bid at Visit 3 (Week 3) for the remaining 9 weeks of the study.
At the Screening and Baseline Visits, and at study visits thereafter (Visit 3-7), subjects will be evaluated for efficacy and safety, and changes in smoking or other tobacco use since the last visit. The following measures will be taken; Fagerstrom Test for Cigarette Dependence (FTCD) at screening only; Cigarette smoking will be assessed by a structured questionnaire of time-line follow-back (TLFB) usage; Expired carbon using a hand-held carbon monoxide monitor; Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS); Global Clinical Impression Scale (CGI-S at baseline, CGI-I at final visit) for TD; C-SSRS; Brief Psychiatric Rating Scale (BPRS), Mini-Mental Status Examination (MMSE) and Hospital Anxiety and Depression Scale (HADS) at baseline and the final visit only; Brief smoking cessation counseling; Laboratory measures; Urine toxicology sample at the screening and final visits only, serum pregnancy test (women) at screening visit only; Changes in psychotropic medications; Varenicline compliance by pill counts; Adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 12 week exploratory, open-label, proof-of-concept, pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics.
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation with varenicline | Other | Drug: VareniclineFDA-approved indication of varenicline for smoking cessation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease
- Glazer-Morgenstern-Doucette criteria for TD
- Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening
- An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening
- Agree to stop smoking by the target date (four weeks after baseline
Key exclusion criteria (15 listed)
- Have untreated or unstable acute medical or psychiatric illnesses
- Have a history of seizures
- History of somnambulism
- Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)
- Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen
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 |
|---|---|---|
| VareniclineAlso: CHANTIXOral medication approved to facilitate smoking cessation | Drug | Smoking cessation with varenicline |
Primary outcome
Self-reported 7-day point prevalence of abstinence prior to week 12
Time frame: 12 weeks
Self-reported 7-day point prevalence of abstinence prior to week 12
3 secondary outcomes
A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
Time frame: 12 weeks
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Time frame: 12 weeks
Abstinence determined by 24-hour point prevalence at week 12
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Background: PubMed 28727483Caroff SN, Campbell EC, Carroll B. Pharmacological treatment of tardive dyskinesia: recent developments. Expert Rev Neurother. 2017 Sep;17(9):871-881. doi: 10.1080/14737175.2017.1358616. Epub 2017 Jul 31.
- Background: PubMed 27514296Caroff SN, Campbell EC. Drug-Induced Extrapyramidal Syndromes: Implications for Contemporary Practice. Psychiatr Clin North Am. 2016 Sep;39(3):391-411. doi: 10.1016/j.psc.2016.04.003. Epub 2016 Jun 23.
- Background: PubMed 20816031Caroff SN, Davis VG, Miller DD, Davis SM, Rosenheck RA, McEvoy JP, Campbell EC, Saltz BL, Riggio S, Chakos MH, Swartz MS, Keefe RS, Stroup TS, Lieberman JA; CATIE Investigators. Treatment outcomes of patients with tardive dyskinesia and chronic schizophrenia. J Clin Psychiatry. 2011 Mar;72(3):295-303. doi: 10.4088/JCP.09m05793yel. Epub 2010 Aug 10.
- Background: PubMed 17388711Caroff SN, Walker P, Campbell C, Lorry A, Petro C, Lynch K, Gallop R. Treatment of tardive dyskinesia with galantamine: a randomized controlled crossover trial. J Clin Psychiatry. 2007 Mar;68(3):410-5. doi: 10.4088/jcp.v68n0309.
- Background: PubMed 16364675Caroff SN, Martine R, Kleiner-Fisman G, Eisa M, Lorry A, Gallop R, Stern MB, Duda JE. Treatment of levodopa-induced dyskinesias with donepezil. Parkinsonism Relat Disord. 2006 May;12(4):261-3. doi: 10.1016/j.parkreldis.2005.10.003. Epub 2005 Dec 20. No abstract available.
- Background: PubMed 27658674Bordia T, Zhang D, Perez XA, Quik M. Striatal cholinergic interneurons and D2 receptor-expressing GABAergic medium spiny neurons regulate tardive dyskinesia. Exp Neurol. 2016 Dec;286:32-39. doi: 10.1016/j.expneurol.2016.09.009. Epub 2016 Sep 19.
- Background: PubMed 26472532Quik M, Bordia T, Zhang D, Perez XA. Nicotine and Nicotinic Receptor Drugs: Potential for Parkinson's Disease and Drug-Induced Movement Disorders. Int Rev Neurobiol. 2015;124:247-71. doi: 10.1016/bs.irn.2015.07.005. Epub 2015 Aug 18.
- Individual participant dataSharing planned: Yes. Final aggregate and pooled data analyses and results devoid of any individual identifying information will be summarized in abstract form for presentations and in a final manuscript for publication at the end of the one-year study period. Final data sets will be shared upon written request for public availability. Data sets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by VA ORD. Prior to distribution, a local privacy officer will certify that the data set contains no PHI
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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.
Stanley N Caroff, MD principal investigator
Cpl. Michael J. Crescenz VA Medical Center
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 Varenicline in people with Schizophrenia and Schizoaffective Disorder, run by Corporal Michael J. Crescenz VA Medical Center 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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 22 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanley N Caroff, MD (215-823-4065, stanley.caroff@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 7-day point prevalence of abstinence prior to week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495024, which also lists 7 linked publications.
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 22 Mar 2019.