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This study has been withdrawn prior to enrollment.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:
Collaborator:
Pfizer
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00571805
First received: December 11, 2007
Last updated: June 9, 2011
Last verified: January 2011
  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
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
Varenicline
Drug: varencline
2.0 mg/day varencline (1.0 mg BID)
Other Name: Chantix
Placebo Comparator: 2
placebo
Drug: placebo
matching placebo
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
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:
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014