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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Primary Purpose

Tobacco Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Varenicline

Placebo pill

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring tobacco, nicotine, cigarette smoking

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Division of Addiction Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

varenicline

placebo pill

Arm Description

Outcomes

Primary Outcome Measures

Cigarette Reduction

50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.

Secondary Outcome Measures

Full Information

NCT ID

NCT01308736

First Posted

January 28, 2011

Last Updated

July 13, 2017

Sponsor

Rutgers, The State University of New Jersey

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01308736

Brief Title

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Official Title

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder

Keywords

tobacco, nicotine, cigarette smoking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

varenicline

Arm Type

Active Comparator

Arm Title

placebo pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Varenicline

Intervention Description

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

Intervention Name(s)

Placebo pill

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cigarette Reduction

Description

50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.

Time Frame

At 6-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc L Steinberg, Ph.D.

Organizational Affiliation

University of Medicine and Dentistry of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Addiction Psychiatry

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

12. IPD Sharing Statement

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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

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