Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt

NCT ID: NCT00571805

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Varenicline

Group Type ACTIVE_COMPARATOR

varencline

Intervention Type DRUG

2.0 mg/day varencline (1.0 mg BID)

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matching placebo

Interventions

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varencline

2.0 mg/day varencline (1.0 mg BID)

Intervention Type DRUG

placebo

matching placebo

Intervention Type DRUG

Other Intervention Names

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Chantix

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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New York University School of Medicine

Principal Investigators

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Malcolm Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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VA New York Harbor Healthcare System, MHAD clinic

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GA30513U

Identifier Type: -

Identifier Source: secondary_id

Varenicline/Smoking

Identifier Type: -

Identifier Source: org_study_id

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