Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia - Full Text View

Sponsors and Collaborators:	University of Maryland National Institute on Drug Abuse (NIDA)
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00554840

Purpose

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.

Condition	Intervention	Phase
Cigarette Smoking Schizophrenia	Drug: varenicline Drug: placebo	Phase II

MedlinePlus related topics: Quitting Smoking Schizophrenia Smoking

Drug Information available for: Varenicline Cotinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

Further study details as provided by University of Maryland:

Primary Outcome Measures:

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 [ Time Frame: The primary endpoint will be point prevalence at 12 weeks. ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
varenicline: Active Comparator	Drug: 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.
placebo: Placebo Comparator	Drug: 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.

Arms

Assigned Interventions

varenicline: Active Comparator

Drug: 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.

placebo: Placebo Comparator

Drug: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554840

Sponsors and Collaborators

University of Maryland

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Elaine Weiner, M.D.

Maryland Psychiatric Research Center

More Information

Responsible Party:	MPRC ( Elaine Weiner )
Study ID Numbers:	H-28948
Study First Received:	November 6, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00554840
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Schizophrenia
Smoking
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 15, 2009