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CompletedNot applicableNCT00790569
Official study title

Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

Study summary

RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiednicotine and varenicline

Plus 1 other study approaches.

Who it may be forBladder Cancer · Cervical Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 6, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Butler Hospital

Study sponsor

01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Not applicable
Sponsor
Butler Hospital
Interventions being studied
Drug: nicotine; Drug: varenicline; Other: placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
  • Interested in quitting smoking
  • Willing to set a quit date 7 days after baseline assessment
  • Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
  • Codac, Inc. (with two independent sites)
  • Addiction Recovery Institute
  • Center for Treatment and Recovery
  • Discovery House
  • Has received methadone for at least the past month
Reasons someone may not be able to joinExclusion criteria
  • Pregnant or nursing (Must have negative pregnancy test)
  • Non-English speaking
  • No personal telephone or does not live close to a relative or neighbor with a telephone
  • Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
  • Unvailable for this study for the next 12 months
  • Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
  • Active skin condition (e.g., psoriasis)
  • History of skin allergy
  • History of a suicide attempt
  • Working as pilots, drivers, or operators of heavy machinery PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No concurrent insulin or blood thinners
  • No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 6, 2018. Always confirm current availability with the study team.

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