MedDataX Logo

Enhancing a High School Based Smoking Cessation Program

NCT ID: NCT01145001

Last Updated: 2016-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nicotine Dependence

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

smoking adolescents contingency management nicotine replacement therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Nicotine Patch and Contingency Management

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

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Weekly CBT for all subjects

Contingency Management

Intervention Type BEHAVIORAL

incentives given for abstinence based on urine analysis

Nicotine Transdermal Patch

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Weekly CBT for all subjects

Nicotine Transdermal Patch

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Weekly CBT for all subjects

Contingency Management

Intervention Type BEHAVIORAL

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

Group Type PLACEBO_COMPARATOR

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Weekly CBT for all subjects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioural Therapy

Weekly CBT for all subjects

Intervention Type BEHAVIORAL

Contingency Management

incentives given for abstinence based on urine analysis

Intervention Type BEHAVIORAL

Nicotine Transdermal Patch

14mg ir 21mg doses based on weight and #cigs/day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Habitrol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suchitra Krishnan-Sarin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CMHC

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P50DA009241-17

Identifier Type: NIH

Identifier Source: secondary_id

View Link

020718574

Identifier Type: -

Identifier Source: org_study_id