NCT01850953

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

May 6, 2013

Last Update Submit

January 26, 2017

Conditions

CravingSmokingSchizophrenia

Keywords

VareniclineSchizophreniasmokingLapse

Outcome Measures

Primary Outcomes (1)

  • Time to Lapse

    The objective of this study is to determine the effect of varenicline versus placebo, on time to lapse using a lapse paradigm.

    Day 6 of week 1 and week 2

Secondary Outcomes (4)

  • Cognitive Function

    Day 6 of week 1 and week 2

  • Tobacco craving

    Day 6 of week 1 and week 2

  • Tobacco withdrawal

    Day 6 of week 1 and week 2

  • Tobacco Reinforcement

    Day 6 of week 1 and week 2

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

This is a sugar pill that will be used as a placebo comparator.

Drug: Placebo

Varenicline

ACTIVE COMPARATOR

Varenicline will be titrated to steady-state levels of 2mg/day over 4 days (0.5mg BID for day 1 and 1.0mg BID for days 2-4) before testing at 2mg/day on days 5 and 6.

Drug: Varenicline

Interventions

VareniclineDRUG

This is an approved smoking cessation medication.

Also known as: Champix, Chantix
Varenicline
PlaceboDRUG
Sugar Pill

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cigarette Smokers (smoke ≥ 10 cigarettes per day)
  • non-treatment seeking (i.e., not trying to quit as indicated by \<7 on the contemplation ladder)
  • aged 18-55
  • Intelligence Quotient (IQ) ≥80 on the Wechsler Test of Adult Reading \[89\]
  • Fagerstrom Test of Nicotine Dependence (FTND) ≥4 \[90\]
  • Patients must meet Structured Clinical Interview for the diagnostic and Statistical Manual for Mental Disorders (SCID-IV) diagnosis criteria for schizophrenia or schizoaffective disorder; be in stable remission from positive symptoms of psychosis as judged by a Positive and Negative Syndrome Scale (PANSS) positive score total score \<70, and receiving a stable dose of antipsychotics for \>1month.
  • Control participants will not be taking any psychotropic medications at the time of enrollment and will not meet diagnostic criteria for any Axis I disorder, except past history of major depression or an anxiety disorder if in remission for at least one year.

You may not qualify if:

  • substance use (except nicotine or caffeine) in the last month
  • a history of alcohol/drug abuse in the 3 months before study enrollment
  • use of opioids (meperidine, oxycodone, methadone, etc)
  • current use of smoking cessation aids (e.g., nicotine replacement therapy, bupropion or varenicline
  • pregnancy or nursing
  • a history of renal insufficiency or a hypersensitivity to varenicline (Champix®)
  • a history of neurological illness like epilepsy or medical condition known to significantly influence neurocognitive function
  • any other medical condition deemed relevant by the Qualified Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

MeSH Terms

Conditions

SmokingSchizophrenia

Interventions

Varenicline

Condition Hierarchy (Ancestors)

BehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Tony George, M.D.

    Centre for Addiction and Mental Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Directot

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 10, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

CA(1)