Clinical trial NCT00554840: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Official title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Schizophrenia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-11-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility 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.

Primary outcomes:
measure: Change of ExpiredCO Level From Baseline
timeFrame: Weekly for 12 weeks
measure: Level of Nicotine Dependence by Treatment Assignment
timeFrame: Weekly for 12 weeks
Secondary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS) - Total Score
timeFrame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
measure: Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
timeFrame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
measure: Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
timeFrame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
measure: Side Effects
timeFrame: Weekly for 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Maryland Psychiatric Research Center
name: Elaine Weiner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: