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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This study has been withdrawn prior to enrollment.
Information provided by:
New York University School of Medicine Identifier:
First received: December 11, 2007
Last updated: June 9, 2011
Last verified: January 2011

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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
Arms Assigned Interventions
Active Comparator: 1
Drug: varencline
2.0 mg/day varencline (1.0 mg BID)
Other Name: Chantix
Placebo Comparator: 2
Drug: placebo
matching placebo
Other Name: placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00571805

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
Principal Investigator: Malcolm Reid, PhD New York University School of Medicine
  More Information

No publications provided

Responsible Party: Malcolm S. Reid, PhD, New York University School of Medicine Identifier: NCT00571805     History of Changes
Other Study ID Numbers: Varenicline/Smoking, GA30513U
Study First Received: December 11, 2007
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
reward processed this record on November 20, 2014