Cigarette SmokingPhase 2NCT00554840
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
A Phase 2 study testing varenicline in people with Cigarette Smoking and Schizophrenia, run by University of Maryland, Baltimore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cigarette Smoking, Schizophrenia
- 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
- 16 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Apr 2011
- Phase
- Phase 2
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
About this study
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.
Read the 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.
- Conditions
- Cigarette Smoking, Schizophrenia
- Being tested
- varenicline, placebo
- Medical subject headings
- Cigarette Smoking, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called chantix, study drug
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.
placeboDrug
Also called sugar pill
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.
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Active comparator | Not described Receives: Drug: varenicline |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ExpiredCO Level From Baseline
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.
Measured: Weekly for 12 weeks
Level of Nicotine Dependence by Treatment Assignment
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.
Measured: Weekly for 12 weeks
Secondary outcomes (4)
Brief Psychiatric Rating Scale (BPRS) - Total Score
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.
Measured: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
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.
Measured: 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
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.
Measured: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Side Effects
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.
Measured: Weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionApr 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- Elaine Weiner, M.D., Principal investigator, Maryland Psychiatric Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554840
- Sponsor's protocol ID
- HP-00042225
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2007
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Livingstone-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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
- ClinicalTrials.gov ID
- NCT00554840
- Acronym / sponsor ID
- HP-00042225
- Conditions
- Cigarette Smoking, Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Active comparator | Drug: varenicline |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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: chantix, study drugSubjects 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. | Drug | varenicline |
| placeboAlso: sugar pillAt 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. | Drug | placebo |
Primary outcome
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.
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.
4 secondary outcomes
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.
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.
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.
Side Effects
Time frame: Weekly for 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Elaine Weiner, M.D. principal investigator
Maryland Psychiatric Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing varenicline in people with Cigarette Smoking and Schizophrenia, run by University of Maryland, Baltimore.
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 13 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Yes. Results are posted in the registry (first posted 15 May 2017). 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?
Change of ExpiredCO Level From Baseline (time frame: Weekly for 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00554840, which also lists 1 linked publication.
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 18 Mar 2022.