- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554840
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
March 16, 2022 updated by: MPRC, University of Maryland, Baltimore
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation.
Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients.
We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups.
Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of < 30 ng/ml.
The primary endpoint will be point prevalence at 12 weeks.
The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated.
The point prevalence abstinence rates will also be obtained.
The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology.
We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group.
Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-64
- Regular ten cigarette per day smoker for one year
- Nicotine Dependency Score greater than or equal to four
- DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
- Psychiatric medication regimen unchanged for at least 90 days
- Psychiatric medication dosage unchanged for at least 30 days
Exclusion Criteria:
- Psychiatric hospitalization in last 6 months
- Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
- Suicide or homicide ideation with a plan in the last six months
- Life time history of suicide attempt
- Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
- Current treatment with Bupropion SR
- DSM-IV diagnosis of alcohol or substance dependence within last 6 months*
- DSM-IV diagnosis of alcohol or substance abuse within three months *
- Pregnancy or lactation in females (+HCG)
- Use of tobacco product other than cigarettes
- Use of nicotine replacements
- Unstable or serious medical condition in last 6 months
- Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week.
Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Other Names:
|
Active Comparator: varenicline
|
Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of ExpiredCO Level From Baseline
Time Frame: Weekly for 12 weeks
|
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment.
Larger negative values represent a greater level of smoking reduction.
|
Weekly for 12 weeks
|
Level of Nicotine Dependence by Treatment Assignment
Time Frame: Weekly for 12 weeks
|
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment.
The total score is computed by adding the scores from the five subscales.
Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
|
Weekly for 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Time Frame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
|
The total BPRS score is calculated by adding the scores for subscales #1-#18.
Each scale ranges from "1=Not Present" to "7=Very Severe".
Total scores range from a minimum score of 18 to a maximum score of 126.
A higher total score indicates a more severe psychiatric symptom rating.
|
Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Time Frame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
|
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content.
Each scale ranges from "1=Not Present" to "7=Very Severe".
The minimum psychosis score is 4 and the maximum psychosis score is 28.
A higher score indicates a more severe psychosis rating.
|
Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Time Frame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
|
The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood.
Each scale ranges from "1=Not Present" to "7=Very Severe".
The minimum anxiety/depression score is 2 and the maximum psychosis score is 14.
A higher score indicates a more severe anxiety/depression rating.
|
Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
|
Side Effects
Time Frame: Weekly for 12 weeks
|
Side effects (33 items) were measured using a Side Effects Checklist (SEC).
The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.
|
Weekly for 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elaine Weiner, M.D., Maryland Psychiatric Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
November 6, 2007
First Submitted That Met QC Criteria
November 6, 2007
First Posted (Estimate)
November 7, 2007
Study Record Updates
Last Update Posted (Actual)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 16, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00042225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on varenicline
-
Arizona State UniversityNational Institute on Drug Abuse (NIDA); Pfizer; University of Nevada, Reno; Los...CompletedSmoking Cessation | Withdrawal Symptoms | Tobacco DependenceUnited States
-
PfizerWithdrawn
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Addiction | Crystal Meth Addiction | Amphetamine AddictionUnited States
-
Korea University Anam HospitalCompletedHealthyKorea, Republic of
-
Butler HospitalBrown UniversityCompletedDepressive Disorder | SmokingUnited States
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)Enrolling by invitation
-
PfizerCompletedSmoking CessationUnited States, Korea, Republic of, Taiwan, Canada, Georgia, Russian Federation
-
Oyster Point Pharma, Inc.CompletedHealthy SubjectsUnited States