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

NCT00571805

Last updated date
Study Location
VA New York Harbor Healthcare System, MHAD clinic
New York, New York, 10010, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nicotine Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- At least 10 cigarettes/day

- Interest in quitting smoking

- Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
Official Title  ICMJE Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Drug: varencline
    2.0 mg/day varencline (1.0 mg BID)
    Other Name: Chantix
  • Drug: placebo
    matching placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Varenicline
    Intervention: Drug: varencline
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 8, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2007)
40
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00571805
Other Study ID Numbers  ICMJE Varenicline/Smoking
GA30513U
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Malcolm S. Reid, PhD, New York University School of Medicine
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Malcolm Reid, PhDNYU Langone Health
PRS Account NYU Langone Health
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP