Selegiline for Smoking Cessation - 1

December 7, 2016 updated by: National Institute on Drug Abuse (NIDA)

Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.

The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • College Park, Maryland, United States, 20745
        • Department of Public & Community Health
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Med School-Tobacco Dep Program
    • Ohio
      • Cincinnati, Ohio, United States, 45237
        • Tri-State Tobacco and Alcohol Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Center for Tobacco Research and Intervention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be at least 18 years of age
  • Be in good general health
  • Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
  • Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
  • Subjects must be motivated to quite smoking
  • If female and of child bearing potential, agrees to use birth control and subject
  • Subject must be able to understand and provide written informed consent.

Exclusion

Criteria:

  • Please contact site for more information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Selegiline Transdermal Patch

Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.

During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Drug: Selegiline Transdermal Patch
Selegiline cm(2) via transdermal system
Other Names:
  • STS Patch
Behavioral: Smoking Cessation Counseling
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Placebo Comparator: Placebo

Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.

During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Behavioral: Smoking Cessation Counseling
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Drug: Placebo
Matching placebo via transdermal system
Other Names:
  • Placebo Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quit Rate
Time Frame: Study weeks 6 through 9
The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).
Study weeks 6 through 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence
Time Frame: week 14
The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.
week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

VA Office of Research and Development

Investigators

  • Principal Investigator: Elbert D Glover, Ph.D., VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CSP-1022-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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