Extended Cessation Treatment for Teen Smokers

Nicotine Dependence Clinical Trial

— Nicoteens  

Official title:

Extended Cessation Treatment for Teen Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459953
• Other study ID #: CA118035
• Secondary ID: R01CA118035
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 11, 2007
• Last updated: June 25, 2013
• Start date: September 2006
• Est. completion date: July 2011

Study information

• Verified date: June 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the efficacy of an extended smoking cessation program for teen smokers. We hypothesize that teen smokers randomized to extended treatment will have a higher abstinence rate at 52 week follow-up than teen smokers receiving only open label treatment.

Description:

Adolescent smokers (aged 14-18; > 10 cigarettes/day) attending continuation high schools in the San Francisco-San Jose Bay Area will serve as the target population for this study. 280 smokers meeting eligibility criteria will be randomized. Our primary goal is to examine the effectiveness of a multi-factor extended treatment strategy in promoting longer-term smoking abstinence. All 280 smokers will receive 10 weeks of open label treatment consisting of nicotine patch therapy and group-based, intensive self-regulatory skills training (ST). Following open label treatment, half (n=140) will receive nine additional group-based ST sessions delivered over a 14 week period. Telephone counseling will also be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=140) will not receive any additional therapy beyond that provided in the open label treatment phase. Abstinence and relapse will be assessed at the end of open label (10 weeks) and extended treatment (24 weeks) and at 52 weeks from the time of study entry. Our primary hypothesis is that smokers randomized to extended treatment will have a higher prolonged abstinence rate (PA) at 52 week follow-up than participants receiving only open label treatment. PA at 52 weeks will be the outcome measure used to evaluate the primary hypothesis and will be defined as a report of non-smoking following an initial 2-week grace period during which any smoking is not counted as a failure and an expired-air carbon monoxide level of <9PPM. Here, failure is defined as either seven consecutive days of smoking or smoking on at least one day on each of two consecutive weeks. Point prevalence abstinence will be examined as a secondary outcome and defined as no smoking, not even a puff, for seven consecutive days prior to assessment and an expired-air carbon monoxide level of <9PPM. With 150 participants per cell, we will have, in general, 80% power at a 2-tailed alpha of .05 to detect a difference in abstinence rates of at least 15% over a large range of success probabilities.

Other known NCT identifiers

• NCT01330069

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

Age 14-18 at the beginning of the study

Smoking at least 10 cigarettes per day

At least one quit attempt in previous 6mos

Exclusion Criteria:

Current DSM-IV disorder (depression, panic disorder, social anxiety disorder and agoraphobia)

Current self report of daily or heavy use (more than three times per week) of any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.)

Positive urine pregnancy test

Currently on bupropion (Wellbutrin, Wellbutrin SR, Zyban) or other antidepressants, MAOI's, antipsychotics, benzodiazepines

Currently on NRT

Currently receiving formal treatment for substance abuse problem, depression or anxiety

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• cognitive and behavioral skills training, nicoderm CQ
all participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. Half of the participants receive an additional 9 sessions of cognitive behavior therapy and half receive brief support

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bailey SR, Harrison CT, Jeffery CJ, Ammerman S, Bryson SW, Killen DT, Robinson TN, Schatzberg AF, Killen JD. Withdrawal symptoms over time among adolescents in a smoking cessation intervention: do symptoms vary by level of nicotine dependence? Addict Behav. 2009 Dec;34(12):1017-22. doi: 10.1016/j.addbeh.2009.06.014. Epub 2009 Jul 5. — View Citation

Bailey, S.R., Hammer, S.A., Jeffery, C.J., Harrison, C.T., Bryson, S.W., Killen, D.T., Ammerman, S. Robinson, T.N., & Killen, J.D. (2013). Extended smoking cessation therapy for teen smokers. Nicotine and Tobacco Research, in press.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prolonged abstinence		end of treatment, 6mos, 12mos	No
Secondary	relapse		12 months	No