Tobacco Use DisorderPhase 3NCT00067158
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1
A Phase 3 study testing nicotine transdermal system in people with Tobacco Use Disorder, run by New York University at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- nicotine transdermal system
- How many people
- 585 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2003to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is alcohol or drug dependent, in Outpatient Drug-Free or Opiate Substitute program and is interested in quitting smoking
Who cannot join
- Patient is psychotic
- Use of smokeless tobacco
- Use of other smoking cessasation product
- Pregnancy
- Patient has hyper-tension, heart problems, or skin condition
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Chelsea Arbor Addictions Treatment Center
Ann Arbor, Michigan, 48103
Piedmont Behavioral Healthcare
Concord, North Carolina, 28001
Psychiatry and Behavioral Medicine Professionals I
Detroit, Michigan, 48207
Narco Freedom (Bridge Plaza)
Long Island City, New York, 11101
Matrix Institute on Addictions
Los Angeles, California, 90016
SPECTRUM
Miami, Florida, 33156
St. Luke's Roosevelt Hospital Center
New York, New York, 10019
St. Luke's Roosevelt Hospital Center, Womens
New York, New York, 10025
Mount Sinai Medical Center
New York, New York, 10029
Center for Drug Free Living
Orlando, Florida, 32805
Behavioral Health Services of Pickens County
Pickens, South Carolina, 29671
Tarzana Treatment Center
Tarzana, California, 91356
Coastal Horizons Center, Inc.
Wilmington, North Carolina, 28412
About this study
Official title: Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- nicotine transdermal system
- Keywords
- nicotine dependence
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine transdermal systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use
Smoking Cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study startApr 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 585 participants
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Investigators
- Malcolm Reid, Ph.D., Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067158
- Sponsor's protocol ID
- NIDA-CTN-0009-1
- Status last verified
- Apr 2010
- First submitted
- 12 Aug 2003
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy
- ClinicalTrials.gov ID
- NCT00067158
- Acronym / sponsor ID
- NIDA-CTN-0009-1
- Conditions
- Tobacco Use Disorder
- Keywords
- nicotine dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 13 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is alcohol or drug dependent, in Outpatient Drug-Free or Opiate Substitute program and is interested in quitting smoking
Key exclusion criteria (5 listed)
- Patient is psychotic
- Use of smokeless tobacco
- Use of other smoking cessasation product
- Pregnancy
- Patient has hyper-tension, heart problems, or skin condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotine transdermal system | Drug | – |
Primary outcome
Drug use
Smoking Cessation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Data ElementsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Reid, Ph.D. principal investigator
New York University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nicotine transdermal system in people with Tobacco Use Disorder, run by New York University at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug use. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.