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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Completed

Conditions

Tobacco Use Disorder

Treatments

Drug: Varenicline
Drug: Placebo pill

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01308736
WS777117

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

73 participants in 2 patient groups, including a placebo group

varenicline
Active Comparator group
Treatment:
Drug: Varenicline
placebo pill
Placebo Comparator group
Treatment:
Drug: Placebo pill

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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