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Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
nicotine transdermal system
Sponsored by
New York University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring nicotine dependence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is alcohol or drug dependent, in Outpatient Drug-Free or Opiate Substitute program and is interested in quitting smoking Exclusion Criteria: Patient is psychotic Use of smokeless tobacco Use of other smoking cessasation product Pregnancy Patient has hyper-tension, heart problems, or skin condition

Sites / Locations

  • Matrix Institute on Addictions
  • Tarzana Treatment Center
  • SPECTRUM
  • Center for Drug Free Living
  • Chelsea Arbor Addictions Treatment Center
  • Psychiatry and Behavioral Medicine Professionals I
  • Narco Freedom (Bridge Plaza)
  • St. Luke's Roosevelt Hospital Center
  • St. Luke's Roosevelt Hospital Center, Womens
  • Mount Sinai Medical Center
  • Piedmont Behavioral Healthcare
  • Coastal Horizons Center, Inc.
  • Behavioral Health Services of Pickens County

Outcomes

Primary Outcome Measures

Drug use
Smoking Cessation

Secondary Outcome Measures

Full Information

First Posted
August 12, 2003
Last Updated
January 11, 2017
Sponsor
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT00067158
Brief Title
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1
Official Title
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New York University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to look at how feasible it is to incorporate a state-of-the-art smoking cessation treatment program into community substance abuse treatment programs and its impact on substance abuse and cigarette smoking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
nicotine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
585 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nicotine transdermal system
Primary Outcome Measure Information:
Title
Drug use
Title
Smoking Cessation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is alcohol or drug dependent, in Outpatient Drug-Free or Opiate Substitute program and is interested in quitting smoking Exclusion Criteria: Patient is psychotic Use of smokeless tobacco Use of other smoking cessasation product Pregnancy Patient has hyper-tension, heart problems, or skin condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Reid, Ph.D.
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90016
Country
United States
Facility Name
Tarzana Treatment Center
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
SPECTRUM
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Center for Drug Free Living
City
Orlando
State/Province
Florida
ZIP/Postal Code
32805
Country
United States
Facility Name
Chelsea Arbor Addictions Treatment Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Psychiatry and Behavioral Medicine Professionals I
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States
Facility Name
Narco Freedom (Bridge Plaza)
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center, Womens
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Piedmont Behavioral Healthcare
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28001
Country
United States
Facility Name
Coastal Horizons Center, Inc.
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
Country
United States
Facility Name
Behavioral Health Services of Pickens County
City
Pickens
State/Province
South Carolina
ZIP/Postal Code
29671
Country
United States

12. IPD Sharing Statement

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Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1

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