Enhancing a High School Based Smoking Cessation Program

NCT01145001 | Completed Results DMC

• 2 other identifiers: 020718574P50DA009241-17
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

smoking; adolescents; contingency management; nicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• Continuous Abstinence During Treatment

  6 weeks

Study Arms (4)

Active Nicotine Patch and Contingency Management

ACTIVE COMPARATOR

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

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

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

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

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

Weekly CBT for all subjects

Active Nicotine Patch and Contingency Management; Nicotine Patch with no Contingency Management; Placebo Patch and no Contingency Management; Placebo patch and Contingency Management

Contingency Management BEHAVIORAL

incentives given for abstinence based on urine analysis

Active Nicotine Patch and Contingency Management; Placebo patch and Contingency Management

Nicotine Transdermal Patch DRUG

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

Also known as: Habitrol

Active Nicotine Patch and Contingency Management; Nicotine Patch with no Contingency Management

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High School aged
• Desire to quit smoking
• Smoking \>5 cigarettes per day
• Able to read and write in English

You may not qualify if:

• Current dependence on other substances
• Medical conditions that would contraindicate the use of a nicotine patch

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

CMHC

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Cognitive Behavioral Therapy; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dana Cavallo, Assistant Professor
• Organization: Yale University

dana.cavallo@yale.edu

2039747607

Study Officials

• Suchitra Krishnan-Sarin, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: January 1, 2015
• Last Updated: December 29, 2016
• Results First Posted: October 19, 2016

Record last verified: 2016-11

Locations

US (1)