Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

NCT01308736 | Completed Results DMC

• 1 other identifier: WS777117
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Keywords

tobacco; nicotine; cigarette smoking

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

varenicline

ACTIVE COMPARATOR

Drug: Varenicline

placebo pill

PLACEBO COMPARATOR

Drug: Placebo pill

Interventions

Varenicline 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.

varenicline

Placebo pill 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.

placebo pill

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must smoke at least 10 cigarettes per day for past 6-months
• Must have a working cellular or land-line phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Pfizer: collaborator

Study Sites (1)

Division of Addiction Psychiatry

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Marc Steinberg
• Organization: Rutgers Robert Wood Johnson Medical School

marc.steinberg@rutgers.edu

7322354341

Study Officials

• Marc L Steinberg, Ph.D.

  University of Medicine and Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: March 4, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 17, 2017
• Results First Posted: July 23, 2015

Record last verified: 2017-07

Locations

US (1)