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

Nicotine Dependence Clinical Trial

— VarenSmoke  

Official title:

Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00571805
• Other study ID #: Varenicline/Smoking
• Secondary ID: GA30513U
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: December 11, 2007
• Last updated: April 8, 2015
• Start date: September 2007

Study information

• Verified date: April 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• varencline
2.0 mg/day varencline (1.0 mg BID)
• placebo
matching placebo

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System, MHAD clinic	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking reward		laboratory test	Yes
Secondary	1 week abstinence induced craving and reward		Day 8, 9, 11 and 14 questionaires	No