Phase 2
Completed N=9
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Cigarette Smoking · Schizophrenia
Source: ClinicalTrials.gov NCT00554840 ↗
Enrolled (actual)
9
Serious AEs
12.5%
Results posted
May 2017
Primary outcomePrimary: Change of ExpiredCO Level From Baseline — -2.88; 9.5; -17.38; -11.5 ppm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of ExpiredCO Level From Baseline |
-2.88; 9.5; -17.38; -11.5; -17.13; -5.75 | — |
| PRIMARY Level of Nicotine Dependence by Treatment Assignment |
5.88; 5.75; 4.5; 5.25; 4.33; 4.75 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) - Total Score |
35.75; 30.25; 33.75; 32.75; 35.5; 30.25 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) - Psychosis Score |
11.25; 10; 8.5; 11.5; 9.25; 8.5 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score |
5.5; 6.75; 3.25; 8; 7.25; 7.25 | — |
| SECONDARY Side Effects |
1; 4; 0; 1; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00554840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.