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Phase 4 Completed N=91 Randomized Double-blind Treatment

Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors

Schizophrenia · Cigarette Smoking
Source: ClinicalTrials.gov NCT00802919 ↗
Enrolled (actual)
91
Serious AEs
3.3%
Results posted
Dec 2017
Primary outcomePrimary: Cotinine Level — 257.9; 258.6; 176.0; 252.1 cotinine ng/ml
◆ Published Evidence
Established
72citations · ~24 / year
Nicotine receptor partial agonists for smoking cessation.
The Cochrane database of systematic reviews · 2023 · Open access · Likely link

Summary

This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.

Linked Publications (2)

  • Nicotine receptor partial agonists for smoking cessation.
    The Cochrane database of systematic reviews · 2023 · 72 citations · Open access · Likely link
  • Varenicline Effects on Smoking, Cognition, and Psychiatric Symptoms in Schizophrenia: A Double-Blind Randomized Trial.
    PloS one · 2016 · 69 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Cotinine Level
257.9; 258.6; 176.0; 252.1; 147.0; 264.6
PRIMARY
Change From Baseline in Cognitive Performance
-0.19; 1.97; 3.03; 4.08; 2.49; 4.33
SECONDARY
Change From Baseline in Psychiatric Symptoms
-3.56; -0.86; -3.05; -0.97; -0.67; 0.23
SECONDARY
Change From Basellne in Calgary Depression Scale Score
-0.63; -0.72; -0.79; -0.88

Eligibility Criteria

Inclusion Criteria

Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication

Exclusion Criteria

prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is >20

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00802919) and the linked publication. 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.

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