Varenicline Adjunctive Treatment in Schizophrenia

Phase 4 Completed 91 enrolled University of Maryland, Baltimore Stanley Medical Research Institute · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.

Timeline

Start: 2007-05
Primary completion: 2010-05
Completion: 2011-04

Outcome

Mixed primary results

registry analysis (unspecified test); Varenicline vs Placebo; p >0.05; ANCOVA; note: All treatment main and interaction effect p-values were \> 0.05. NCT00492349 ↗

registry analysis (unspecified test); Varenicline vs Placebo; p <0.05; ANCOVA NCT00492349 ↗

Publications

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Hong LE, Thaker GK, McMahon RP, Summerfelt A, Rachbeisel J, Fuller RL, Wonodi I, Buchanan RW, Myers C, Heishman SJ, Yang J, Nye A. Effects of moderate-dose treatment with varenicline on neurobiological and cognitive biomarkers in smokers and nonsmokers with schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 2011 Dec;68(12):1195-206. doi: 10.1001/archgenpsychiatry.2011.83. Epub 2011 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varenicline	Small molecule	0.5 mg	Oral