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Enhancing a High School Based Smoking Cessation Program

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01145001
First received: June 14, 2010
Last updated: August 24, 2016
Last verified: August 2016
Results First Received: August 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Behavioral: Cognitive Behavioural Therapy
Behavioral: Contingency Management
Drug: Nicotine Transdermal Patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Nicotine Patch and Contingency Management

Subjects in this group will receive Contingency Management and active nicotine patch

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Contingency Management: incentives given for abstinence based on urine analysis

Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day

Nicotine Patch With no Contingency Management

Subjects in this group will receive active nicotine patch without contingency management for abstinence

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day

Placebo Patch and Contingency Management

Subjects in this group will receive a placebo transdermal patch and contingency management

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Contingency Management: incentives given for abstinence based on urine analysis

Placebo Patch and no Contingency Management

Subjects in this group will receive a placebo patch and will not receive contingency management

Cognitive Behavioural Therapy: Weekly CBT for all subjects


Participant Flow:   Overall Study
    Active Nicotine Patch and Contingency Management   Nicotine Patch With no Contingency Management   Placebo Patch and Contingency Management   Placebo Patch and no Contingency Management
STARTED   36   37   44   37 
COMPLETED   28   31   39   31 
NOT COMPLETED   8   6   5   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Nicotine Patch and Contingency Management

Subjects in this group will receive Contingency Management and active nicotine patch

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Contingency Management: incentives given for abstinence based on urine analysis

Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day

Nicotine Patch With no Contingency Management

Subjects in this group will receive active nicotine patch without contingency management for abstinence

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day

Placebo Patch and Contingency Management

Subjects in this group will receive a placebo transdermal patch and contingency management

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Contingency Management: incentives given for abstinence based on urine analysis

Placebo Patch and no Contingency Management

Subjects in this group will receive a placebo patch and will not receive contingency management

Cognitive Behavioural Therapy: Weekly CBT for all subjects

Total Total of all reporting groups

Baseline Measures
   Active Nicotine Patch and Contingency Management   Nicotine Patch With no Contingency Management   Placebo Patch and Contingency Management   Placebo Patch and no Contingency Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   37   44   37   154 
Age 
[Units: Participants]
         
<=18 years   34   36   42   37   149 
Between 18 and 65 years   2   1   2   0   5 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.53  (1.276)   16.62  (1.233)   16.66  (1.01)   16.30  (1.151)   16.53  (1.161) 
Gender 
[Units: Participants]
         
Female   11   14   17   17   59 
Male   25   23   27   20   95 
Region of Enrollment 
[Units: Participants]
         
United States   36   37   44   37   154 


  Outcome Measures

1.  Primary:   Abstinence Rates at the End of Treatment   [ Time Frame: 6 weeks ]

2.  Secondary:   Abstinence Rates During Treatment   [ Time Frame: 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dana Cavallo, Assistant Professor
Organization: Yale University
phone: 2039747607
e-mail: dana.cavallo@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01145001     History of Changes
Other Study ID Numbers: 020718574
P50DA009241-17 ( US NIH Grant/Contract Award Number )
Study First Received: June 14, 2010
Results First Received: August 24, 2016
Last Updated: August 24, 2016
Health Authority: United States: Institutional Review Board