Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00554840
First received: November 6, 2007
Last updated: June 5, 2008
Last verified: June 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

Resource links provided by NLM:


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
Active Comparator: varenicline 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.
Other Name: chantix, study drug
Placebo Comparator: placebo 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.
Other Name: sugar pill

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Elaine Weiner, M.D. University of Maryland
  More Information

No publications provided

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014