NCT00571805

Brief Summary

Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

First QC Date

December 11, 2007

Last Update Submit

April 8, 2015

Conditions

Nicotine Dependence

Keywords

cigarettecravingreward

Outcome Measures

Primary Outcomes (1)

  • Smoking reward

    laboratory test

Secondary Outcomes (1)

  • 1 week abstinence induced craving and reward

    Day 8, 9, 11 and 14 questionaires

Study Arms (2)

1

ACTIVE COMPARATOR

Varenicline

Drug: varencline

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

varenclineDRUG

2.0 mg/day varencline (1.0 mg BID)

Also known as: Chantix
1
placeboDRUG

matching placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 10 cigarettes/day
  • Interest in quitting smoking
  • Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test

You may not qualify if:

  • Pregnancy
  • Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult.
  • Clinically significant medical condition in opinion of study clinician
  • Drug or alcohol dependence inlast 12 months
  • Use of other smoking cessation medications ot treatment progams in last 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA New York Harbor Healthcare System, MHAD clinic

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Malcolm Reid, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

September 1, 2007

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

US(1)