Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia

NCT01850953 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-01-27

No results posted yet for this study

Summary

The objective of this study is to determine the mechanisms by which varenicline, an effective smoking cessation treatment, protects against relapse. Varenicline will be administered in smokers with schizophrenia and control smokers using a randomized, double-blind, cross-over design. Smokers will be asked to stop smoking overnight; the next day the ability to resist smoking will be assessed in a laboratory smoking lapse paradigm. Measures of tobacco craving, reinforcement and withdrawal-related cognitive dysfunction will be correlated with time to lapse. The results could have significant clinical implications by identifying mechanisms by which smokers with schizophrenia are at more risk for relapse than the general population, leading to the development of more effective smoking cessation therapies.

Conditions

Interventions

DRUG

Varenicline

This is an approved smoking cessation medication.

DRUG

Placebo

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY
  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Tony George, M.D. · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01850953 on ClinicalTrials.gov