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

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

This study is currently recruiting participants.

Verified by New York University School of Medicine, October 2007

Sponsors and Collaborators:	New York University School of Medicine Pfizer
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00571805

Purpose

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.

Condition	Intervention	Phase
Nicotine Dependence	Drug: varencline Drug: placebo	Phase I Phase II

MedlinePlus related topics: Smoking

Drug Information available for: Varenicline Nicotine polacrilex Nicotine tartrate

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Pharmacodynamics Study
Official Title:	Placebo-Controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Smoking reward [ Time Frame: laboratory test ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1 week abstinence induced craving and reward [ Time Frame: Day 8, 9, 11 and 14 questionaires ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Active Comparator Varenicline	Drug: varencline 2.0 mg/day varencline (1.0 mg BID)
2: Placebo Comparator placebo	Drug: placebo matching placebo

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571805

Contacts

Contact: Erin Weinstein, BA

212-686-7500 ext 4661

Locations

United States, New York
VA New York Harbor Healthcare System, MHAD clinic	Recruiting
New York, New York, United States, 10010
Contact: Erin Weinstein, BA 212-686-7500 ext 4661 erin.weinstein@va.gov
Principal Investigator: Malcolm Reid, Ph.D.

Sponsors and Collaborators

New York University School of Medicine

Pfizer

Investigators

Principal Investigator:

Malcolm Reid, PhD

New York University School of Medicine

More Information

Responsible Party:	New York University School of Medicine ( Malcolm S. Reid, PhD )
Study ID Numbers:	Varenicline/Smoking, GA30513U
Study First Received:	December 11, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00571805
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

cigarette
craving
reward

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine
Mental Disorders

Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 13, 2009