SchizophreniaPhase 4NCT00727103
Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia
A Phase 4 study testing Varenicline in people with Schizophrenia and Schizoaffective Disorder, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Alcohol Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2011
- Phase
- Phase 4
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment
- Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)
- Current DSM-IV diagnosis of Nicotine Dependence
- Current DSM-IV diagnosis of Alcohol Dependence
- Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)
- An average of at least one pack of cigarettes per day (>=20 cigarettes/day) over the 7 days prior to intake
- An average of at least 7 drinks over the 7 days prior to intake
Who cannot join
- Inability to give adequate informed consent
- Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.
- Currently taking naltrexone (ReVia), Campral or Antabuse
- Participation in a clinical trial less than 3 months prior to intake
- History of suicide attempt in the past year
- History of hospitalization due to suicidal ideation in the past year
Show all 19Show fewer
- Suicidal ideation at baseline
- Known allergic reaction to varenicline
- Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.
- Female patients who are pregnant or nursing.
- Significant unstable medical problems (e.g. impaired renal function).
- Significant unstable psychiatric disorders.
- Subjects who do not attend all required screening appointments.
- Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
- Positive urine drug screen for cocaine, opioids or amphetamine at baseline
- Current DSM-IV diagnosis of Cocaine, Opioid or Cannabis Dependence (1 month prior to enrollment)
- Metal implants or devices (e.g. aneurysm clips, cochlear implants, neural stimulators, cardiac pacemakers)
- Weight over 250 lbs
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.
Read the detailed description
Alcohol use (more than 33%) and smoking (80-90%) commonly occur together in patients with schizophrenia. Varenicline (ChantixTM) has been approved by the FDA as a medication for smoking cessation. Recent animal studies have shown that chronic varenicline administration decreased alcohol consumption. There are no human data available on the effectiveness of varenicline in alcohol-use disorders.
The aim of the proposed pilot study is to find out whether varenicline treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.
The proposed pilot study will enroll a cohort of up to 30 subjects with schizophrenia or schizoaffective disorder and nicotine and alcohol dependence, who are receiving ongoing outpatient mental health treatment from community providers. Subjects will be randomly assigned to one of the two treatment groups (varenicline vs. placebo). Following a one week screening phase, participants will be seen on day 4, day 8, then weekly over an 8-week treatment period. One week supply of medication will be dispensed at each study visit, with the exception of the first week, when only 4 days supply will be given on 2 days (visit 1 and 2). One month after discontinuation of medication, a follow-up interview will be conducted.
Varenicline and placebo will be dispensed in 0.5 mg and 1 mg color coded capsules. During the first 3 days of treatment, participants will take one 0.5 mg tablet of varenicline (or placebo) by mouth daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg by mouth twice daily for 4 days. From day 8, the dose will be increased to the standard dosing schedule of 1 mg (1 tablet) by mouth twice daily. At the end of the 8th week, varenicline will be discontinued.
A structured clinical psychiatric interview and physical exam will be performed at baseline, along with a urine drug screen, which will be repeated on week 8, and at 1 month follow-up. Blood tests (complete blood count, basic metabolic panel, liver function tests) will be performed at baseline, then monthly.
During weekly study visits patients will undergo breath carbon-monoxide and breath alcohol testing, and they will answer questions about depression, smoking and alcohol use. Detailed assessment of psychiatric symptom severity (including neuropsychological testing) will be performed at baseline, at the end of the treatment phase (week 8). A functional MRI study will be performed at baseline and at the end of study to assess changes in blood flow, emotional processing and working memory related to varenicline treatment. In addition, genetic polymorphism of the α4β2 nicotinic acetylcholine receptor and gene expression changes related to drinking/smoking/psychosis and varenicline treatment will also be assessed.
The primary objectives of the proposed study are two fold: first to determine the feasibility of conducting a similar study on a larger scale, and second to establish pilot data for determining the effect size for hypothesized treatment effects on alcohol and nicotine use based on objective tests and self report. These estimates will help inform the minimum sample size needed for a larger future trial.
- Being tested
- Varenicline, Placebo
- Keywords
- Varenicline, Smoking cessation, Schizophrenia, Schizoaffective disorder, Alcohol dependence, Nicotine dependence
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Alcoholism, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Varenicline will be dispensed in 0.5 mg and 1 mg tablets taken orally. During the first 3 days of medication, participants will take one 0.5 mg tablet of varenicline daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 mg (1 tablet) po twice daily. At the end of the 8th week, varenicline will be discontinued.
PlaceboDrug
Placebo will be dispensed in color-coded capsules. Blue capsules will contain 0.5 mg glucose (placebo), red capsules will contain 1 mg glucose (placebo).
| Study group | Role | What they receive |
|---|---|---|
| 1 Varenicline | Active comparator | Varenicline will be dispensed in 0.5 mg (blue capsules containing a 0.5 mg varenicline tablet) and 1 mg (red capsules containing a 1 mg varenicline tablet) capsules taken orally. During the first 3 days of medication, participants will take one blue capsule (0.5 mg tablet) of varenicline daily. If the medication is well-tolerated, the dose will be increased to one blue capsule (0.5 mg) po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 red capsule (1 mg) po twice daily. At the end of the 8th week, varenicline will be discontinued. Receives: Drug: Varenicline |
| 2 Placebo | Placebo comparator | Placebo will be dispensed in blue and red color coded capsules. During the first 3 days, participants will take one blue capsule po daily. If the medication is well-tolerated, the dose will be increased to one blue capsule po twice daily for 4 days. On day 8, the patients will take 1 red capsule po twice daily. At the end of the 8th week, placebo will be discontinued. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data.
Measured: 8 weeks
Secondary outcomes (4)
The outcome measure for smoking cessation effectiveness will be the amount of carbon monoxide in expired air at the end of the treatment phase, relative to data collected at baseline and during treatment.
Measured: 8 weeks
The safety of Varenicline use will be determined by examination of adverse events observed during the course of this investigation, with particular emphasis on comparing the frequency of adverse events in Placebo versus Treatment groups.
Measured: 8 weeks
Improvement in cognition will be assessed using the standardized California Verbal Learning Test (CVLT).
Measured: 8 weeks
Improvement in negative symptoms will be assessed using the PANSS negative score.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Zsuzsa Szombathyne Meszaros, MD, PhD, Principal investigator, SUNY Upstate Medical University, Department of PsychiatrySteven L Batki, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727103
- Sponsor's protocol ID
- SUNY UMU IRBPHS #5656
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2008
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meszaros ZS, Abdul-Malak Y, Dimmock JA, Wang D, Ajagbe TO, Batki SL. Varenicline treatment of concurrent alcohol and nicotine dependence in schizophrenia: a randomized, placebo-controlled pilot trial. J Clin Psychopharmacol. 2013 Apr;33(2):243-7. doi: 10.1097/JCP.0b013e3182870551.
PubMed 23422399Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00727103
- Acronym / sponsor ID
- SUNY UMU IRBPHS #5656
- Keywords
- Varenicline, Smoking cessation, Schizophrenia, Schizoaffective disorder, Alcohol dependence, Nicotine dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jul 2008 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Aug 2008 (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.
The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.
Detailed description
Alcohol use (more than 33%) and smoking (80-90%) commonly occur together in patients with schizophrenia. Varenicline (ChantixTM) has been approved by the FDA as a medication for smoking cessation. Recent animal studies have shown that chronic varenicline administration decreased alcohol consumption. There are no human data available on the effectiveness of varenicline in alcohol-use disorders.
The aim of the proposed pilot study is to find out whether varenicline treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.
The proposed pilot study will enroll a cohort of up to 30 subjects with schizophrenia or schizoaffective disorder and nicotine and alcohol dependence, who are receiving ongoing outpatient mental health treatment from community providers. Subjects will be randomly assigned to one of the two treatment groups (varenicline vs. placebo). Following a one week screening phase, participants will be seen on day 4, day 8, then weekly over an 8-week treatment period. One week supply of medication will be dispensed at each study visit, with the exception of the first week, when only 4 days supply will be given on 2 days (visit 1 and 2). One month after discontinuation of medication, a follow-up interview will be conducted.
Varenicline and placebo will be dispensed in 0.5 mg and 1 mg color coded capsules. During the first 3 days of treatment, participants will take one 0.5 mg tablet of varenicline (or placebo) by mouth daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg by mouth twice daily for 4 days. From day 8, the dose will be increased to the standard dosing schedule of 1 mg (1 tablet) by mouth twice daily. At the end of the 8th week, varenicline will be discontinued.
A structured clinical psychiatric interview and physical exam will be performed at baseline, along with a urine drug screen, which will be repeated on week 8, and at 1 month follow-up. Blood tests (complete blood count, basic metabolic panel, liver function tests) will be performed at baseline, then monthly.
During weekly study visits patients will undergo breath carbon-monoxide and breath alcohol testing, and they will answer questions about depression, smoking and alcohol use. Detailed assessment of psychiatric symptom severity (including neuropsychological testing) will be performed at baseline, at the end of the treatment phase (week 8). A functional MRI study will be performed at baseline and at the end of study to assess changes in blood flow, emotional processing and working memory related to varenicline treatment. In addition, genetic polymorphism of the α4β2 nicotinic acetylcholine receptor and gene expression changes related to drinking/smoking/psychosis and varenicline treatment will also be assessed.
The primary objectives of the proposed study are two fold: first to determine the feasibility of conducting a similar study on a larger scale, and second to establish pilot data for determining the effect size for hypothesized treatment effects on alcohol and nicotine use based on objective tests and self report. These estimates will help inform the minimum sample size needed for a larger future trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Varenicline | Active comparator | Drug: VareniclineVarenicline will be dispensed in 0.5 mg (blue capsules containing a 0.5 mg varenicline tablet) and 1 mg (red capsules containing a 1 mg varenicline tablet) capsules taken orally. During the first 3 days of medication, participants will take one blue capsule (0.5 mg tablet) of varenicline daily. If the medication is well-tolerated, the dose will be increased to one blue capsule (0.5 mg) po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 red capsule (1 mg) po twice daily. At the end of the 8th week, varenicline will be discontinued. |
| 2 Placebo | Placebo comparator | Drug: PlaceboPlacebo will be dispensed in blue and red color coded capsules. During the first 3 days, participants will take one blue capsule po daily. If the medication is well-tolerated, the dose will be increased to one blue capsule po twice daily for 4 days. On day 8, the patients will take 1 red capsule po twice daily. At the end of the 8th week, placebo will be discontinued. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment
- Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)
- Current DSM-IV diagnosis of Nicotine Dependence
- Current DSM-IV diagnosis of Alcohol Dependence
- Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)
Key exclusion criteria (19 listed)
- Inability to give adequate informed consent
- Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.
- Currently taking naltrexone (ReVia), Campral or Antabuse
- Participation in a clinical trial less than 3 months prior to intake
- History of suicide attempt in the past year
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: ChantixVarenicline will be dispensed in 0.5 mg and 1 mg tablets taken orally. During the first 3 days of medication, participants will take one 0.5 mg tablet of varenicline daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 mg (1 tablet) po twice daily. At the end of the 8th week, varenicline will be discontinued. | Drug | 1 Varenicline |
| PlaceboPlacebo will be dispensed in color-coded capsules. Blue capsules will contain 0.5 mg glucose (placebo), red capsules will contain 1 mg glucose (placebo). | Drug | 2 Placebo |
Primary outcome
The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data.
Time frame: 8 weeks
4 secondary outcomes
The outcome measure for smoking cessation effectiveness will be the amount of carbon monoxide in expired air at the end of the treatment phase, relative to data collected at baseline and during treatment.
Time frame: 8 weeks
The safety of Varenicline use will be determined by examination of adverse events observed during the course of this investigation, with particular emphasis on comparing the frequency of adverse events in Placebo versus Treatment groups.
Time frame: 8 weeks
Improvement in cognition will be assessed using the standardized California Verbal Learning Test (CVLT).
Time frame: 8 weeks
Improvement in negative symptoms will be assessed using the PANSS negative score.
Time frame: 8 weeks
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 8 Feb 2024.
- Results publication: PubMed 23422399Meszaros ZS, Abdul-Malak Y, Dimmock JA, Wang D, Ajagbe TO, Batki SL. Varenicline treatment of concurrent alcohol and nicotine dependence in schizophrenia: a randomized, placebo-controlled pilot trial. J Clin Psychopharmacol. 2013 Apr;33(2):243-7. doi: 10.1097/JCP.0b013e3182870551.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Zsuzsa Szombathyne Meszaros, MD, PhD principal investigator
SUNY Upstate Medical University, Department of Psychiatry
Steven L Batki, MD study director
University of California, San Francisco
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 State University of New York - Upstate Medical 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 7 inclusion and 19 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 Feb 2024. 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?
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?
The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (time frame: 8 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 NCT00727103, which also lists 2 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 8 Feb 2024.