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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571805
First Posted: December 12, 2007
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
New York University School of Medicine
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Smoking reward [ Time Frame: laboratory test ]

Secondary Outcome Measures:
  • 1 week abstinence induced craving and reward [ Time Frame: Day 8, 9, 11 and 14 questionaires ]

Enrollment: 0
Study Start Date: September 2007
Arms Assigned Interventions
Active Comparator: 1
Varenicline
Drug: varencline
2.0 mg/day varencline (1.0 mg BID)
Other Name: Chantix
Placebo Comparator: 2
placebo
Drug: placebo
matching placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571805


Locations
United States, New York
VA New York Harbor Healthcare System, MHAD clinic
New York, New York, United States, 10010
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: Malcolm S. Reid, PhD, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00571805     History of Changes
Other Study ID Numbers: Varenicline/Smoking
GA30513U
First Submitted: December 11, 2007
First Posted: December 12, 2007
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by New York University School of Medicine:
cigarette
craving
reward

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs