Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Tobacco Use Disorder Clinical Trial

Official title:

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308736
• Other study ID #: WS777117
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: July 13, 2017
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: July 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Must smoke at least 10 cigarettes per day for past 6-months

• Must have a working cellular or land-line phone

Exclusion Criteria:

• Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes

• Must not be currently receiving tobacco dependence treatment counseling

• Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)

• Must not have positive screen on SCID-I/NP Psychotic Screen

• Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
• Placebo pill
Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.

Locations

Country	Name	City	State
United States	Division of Addiction Psychiatry	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette Reduction	50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.	At 6-month follow-up