Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

NCT ID: NCT01308736

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

varenicline

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo pill

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Marc L. Steinberg, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc L Steinberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Dentistry of New Jersey

Locations

Division of Addiction Psychiatry

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

WS777117

Identifier Type: -

Identifier Source: org_study_id