Enhancing a High School Based Smoking Cessation Program
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ClinicalTrials.gov Identifier: NCT01145001 |
Recruitment Status :
Completed
First Posted : June 16, 2010
Results First Posted : October 19, 2016
Last Update Posted : December 29, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nicotine Dependence | Behavioral: Cognitive Behavioural Therapy Behavioral: Contingency Management Drug: Nicotine Transdermal Patch | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Active Nicotine Patch and Contingency Management
Subjects in this group will receive Contingency Management and active nicotine patch
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Behavioral: Cognitive Behavioural Therapy
Weekly CBT for all subjects Behavioral: Contingency Management incentives given for abstinence based on urine analysis Drug: Nicotine Transdermal Patch 14mg ir 21mg doses based on weight and #cigs/day
Other Name: Habitrol |
Active Comparator: Nicotine Patch with no Contingency Management
Subjects in this group will receive active nicotine patch without contingency management for abstinence
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Behavioral: Cognitive Behavioural Therapy
Weekly CBT for all subjects Drug: Nicotine Transdermal Patch 14mg ir 21mg doses based on weight and #cigs/day
Other Name: Habitrol |
Placebo Comparator: Placebo patch and Contingency Management
Subjects in this group will receive a placebo transdermal patch and contingency management
|
Behavioral: Cognitive Behavioural Therapy
Weekly CBT for all subjects Behavioral: Contingency Management incentives given for abstinence based on urine analysis |
Placebo Comparator: Placebo Patch and no Contingency Management
Subjects in this group will receive a placebo patch and will not receive contingency management
|
Behavioral: Cognitive Behavioural Therapy
Weekly CBT for all subjects |
- 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.
- Continuous Abstinence During Treatment [ Time Frame: 6 weeks ]We will also examine continuous abstinence during the six week treatment period by urine analysis each week.

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Ages Eligible for Study: | 14 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- High School aged
- Desire to quit smoking
- Smoking >5 cigarettes per day
- Able to read and write in English
Exclusion Criteria:
- Current dependence on other substances
- Medical conditions that would contraindicate the use of a nicotine patch

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145001
United States, Connecticut | |
CMHC | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Suchitra Krishnan-Sarin, Ph.D. | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01145001 |
Other Study ID Numbers: |
020718574 P50DA009241-17 ( U.S. NIH Grant/Contract ) |
First Posted: | June 16, 2010 Key Record Dates |
Results First Posted: | October 19, 2016 |
Last Update Posted: | December 29, 2016 |
Last Verified: | November 2016 |
smoking adolescents contingency management nicotine replacement therapy |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |