Youth Smoking Cessation: Therapy +/- "The Patch"

NCT00631020 | Completed Results DMC

• 1 other identifier: PM 20063287
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Reducing tobacco use by adolescents is a national health priority. In recent polls, most adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative health consequences. Given the need for effective smoking cessation programs aimed at youth, scientifically rigorous research is warranted to reduce adolescent smoking. This project will address gaps in the scientific treatment literature. The goal of this project is to develop a tailored, practical, and efficacious smoking cessation intervention. Combined with other efforts in the field, this work can provide an initial guide to an evidence-based treatment for smoking cessation in youth. In keeping with developments in other fields of medicine, we believe that further advances in smoking cessation will move towards a goal of personalized treatment. Such an individualized approach for adolescent smoking cessation will be informed by further investigation of the relationships between outcomes in this trial. To serve these goals, we propose the following program: Youths who smoke regularly will receive a 6 week intervention using "cognitive-behavioral motivational enhancement" (CBME) supplemented by nicotine replacement therapy (NRT), if youth and parents desire this option. Furthermore, youth has to smoke more than 5 cigarettes a day in order to qualify for nicotine replacement therapy. This approach is consistent with treatment guidelines for smoking cessation (Fiore 2000). Compared with participants who fail to achieve smoking cessation, those who successfully achieve smoking abstinence during intervention, will have lower baseline rates of comorbid ADHD, lower depressive symptom scores, enhanced readiness to quit, more negative attitudes towards smoking, fewer friends who smoke, and fewer family members who smoke. The investigators predict that the intervention will help youth to quit smoking and will examine predictions of successful quitting.

Conditions

Smoking

Keywords

Youth; Smoking; Tobacco; Adolescent; Dependence; Teen smoking; Smoking and youth; Youth and tobacco

Outcome Measures

Primary Outcomes (3)

• Acceptance of Nicotine Replacement Therapy

  Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.

  week 2

• Retention in Trial

  Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)

  week 6

• 7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)

  The primary index of smoking behavior will be subject's self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of \<=8 ppm.

  week 6, 12, 16 and 24

Secondary Outcomes (3)

• Changes in Tobacco Withdrawal Symptoms Compared to Baseline

  Weeks 6, 12, 16 and 24

• Change in Tobacco Dependence Compared to Baseline

  Weeks 6, 12, 16 and 24

• Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline

  Weeks 6, 12, 16 and 24

Study Arms (1)

CBME +/- NRT

EXPERIMENTAL

6 weeks CBME with optional 4 weeks NRT

Behavioral: CBME; Drug: Optional NRT

Interventions

CBME BEHAVIORAL

6 weeks of once a week one-on-one CBME

CBME +/- NRT

Optional NRT DRUG

NicoDerm CQ nicotine transdermal patch

CBME +/- NRT

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age of 14-21 years, inclusive
• regular cigarette smoking at least five times a day in the month before entry into the study and initiation of smoking at least 6 months before entry
• A score of 35 or greater on the Cigarette Dependence Scale-12
• youth provide informed assent (for youth \<18 yr) or consent (for youth ≥18 yr) and parents provide informed consent to participate in the project
• documented approval to participate from the participant's treating physician for participants currently receiving treatment for a serious medical or psychiatric condition
• current contact information (address, telephone number), which is needed for follow-up
• able to complete study assessments and participate in the intervention (e.g., lives \< 1 hr. away from the site, has family to participate in the intervention, does not have mental retardation)
• youth or primary caregivers speak English or Spanish

You may not qualify if:

• smoke less than 5 cigarettes per day
• have serious cardiovascular disease, including uncontrolled hypertension, coronary artery disease, serious cardiac arrhythmias, vasospastic disease, or angina, due to potential cardiovascular effects of nicotine, as determined via the baseline medical history and physical exam
• have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
• have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
• have a known allergy to nicotine or any component of the nicotine patches
• be receiving treatment with adenosine or bupropion due to potential drug-drug interactions
• be pregnant or sexually active and not using reliable birth control methods consistently (for females)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Philip Morris USA: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Steven Shoptaw
• Organization: UCLA Center for Health Promotion and Disease Prevention

sshoptaw@mednet.ucla.edu

310-794-0619

Study Officials

• Steven Shoptaw, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 22, 2015
• Results First Posted: April 22, 2015

Record last verified: 2015-04

Locations

US (1)