Nicotine DependenceNCT01145001
Enhancing a High School Based Smoking Cessation Program
A study testing Cognitive Behavioural Therapy, Contingency Management and Nicotine Transdermal Patch in people with Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Cognitive Behavioural Therapy, Contingency Management and Nicotine Transdermal Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- High School aged
- Desire to quit smoking
- Smoking >5 cigarettes per day
- Able to read and write in English
Who cannot join
- Current dependence on other substances
- Medical conditions that would contraindicate the use of a nicotine patch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program
The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.
- Conditions
- Nicotine Dependence
- Being tested
- Cognitive Behavioural Therapy, Contingency Management, Nicotine Transdermal Patch
- Keywords
- smoking, adolescents, contingency management, nicotine replacement therapy
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Weekly CBT for all subjects
Contingency ManagementBehavioural
incentives given for abstinence based on urine analysis
Nicotine Transdermal PatchDrug
Also called Habitrol
14mg ir 21mg doses based on weight and #cigs/day
| Study group | Role | What they receive |
|---|---|---|
| Active Nicotine Patch and Contingency Management | Active comparator | Subjects in this group will receive Contingency Management and active nicotine patch Receives: Behavioral: Cognitive Behavioural Therapy; Behavioral: Contingency Management; Drug: Nicotine Transdermal Patch |
| Nicotine Patch with no Contingency Management | Active comparator | Subjects in this group will receive active nicotine patch without contingency management for abstinence Receives: Behavioral: Cognitive Behavioural Therapy; Drug: Nicotine Transdermal Patch |
| Placebo patch and Contingency Management | Placebo comparator | Subjects in this group will receive a placebo transdermal patch and contingency management Receives: Behavioral: Cognitive Behavioural Therapy; Behavioral: Contingency Management |
| Placebo Patch and no Contingency Management | Placebo comparator | Subjects in this group will receive a placebo patch and will not receive contingency management Receives: Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence Rates at the End of Treatment
Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.
Measured: 6 weeks
Secondary outcomes (1)
Continuous Abstinence During Treatment
We will also examine continuous abstinence during the six week treatment period by urine analysis each week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Yale 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Suchitra Krishnan-Sarin, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145001
- Sponsor's protocol ID
- 020718574
- Other IDs
- P50DA009241-17
- Status last verified
- Nov 2016
- First submitted
- 14 Jun 2010
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program
- ClinicalTrials.gov ID
- NCT01145001
- Acronym / sponsor ID
- 020718574
- Conditions
- Nicotine Dependence
- Keywords
- smoking, adolescents, contingency management, nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Posted 19 Oct 2016
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 examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Nicotine Patch and Contingency Management | Active comparator | Behavioral: Cognitive Behavioural Therapy, Behavioral: Contingency Management, Drug: Nicotine Transdermal PatchSubjects in this group will receive Contingency Management and active nicotine patch |
| Nicotine Patch with no Contingency Management | Active comparator | Behavioral: Cognitive Behavioural Therapy, Drug: Nicotine Transdermal PatchSubjects in this group will receive active nicotine patch without contingency management for abstinence |
| Placebo patch and Contingency Management | Placebo comparator | Behavioral: Cognitive Behavioural Therapy, Behavioral: Contingency ManagementSubjects in this group will receive a placebo transdermal patch and contingency management |
| Placebo Patch and no Contingency Management | Placebo comparator | Behavioral: Cognitive Behavioural TherapySubjects in this group will receive a placebo patch and will not receive contingency management |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- High School aged
- Desire to quit smoking
- Smoking >5 cigarettes per day
- Able to read and write in English
Key exclusion criteria (2 listed)
- Current dependence on other substances
- Medical conditions that would contraindicate the use of a nicotine patch
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 |
|---|---|---|
| Cognitive Behavioural TherapyWeekly CBT for all subjects | Behavioural | Active Nicotine Patch and Contingency Management, Nicotine Patch with no Contingency Management, Placebo Patch and no Contingency Management, Placebo patch and Contingency Management |
| Contingency Managementincentives given for abstinence based on urine analysis | Behavioural | Active Nicotine Patch and Contingency Management, Placebo patch and Contingency Management |
| Nicotine Transdermal PatchAlso: Habitrol14mg ir 21mg doses based on weight and #cigs/day | Drug | Active Nicotine Patch and Contingency Management, Nicotine Patch with no Contingency Management |
Primary outcome
Abstinence Rates at the End of Treatment
Time frame: 6 weeks
Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.
1 secondary outcome
Continuous Abstinence During Treatment
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suchitra Krishnan-Sarin, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy, Contingency Management and Nicotine Transdermal Patch in people with Nicotine Dependence, run by Yale University at 1 site 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 4 inclusion and 2 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Abstinence Rates at the End of Treatment (time frame: 6 weeks). 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 29 Dec 2016.