Nicoteens: Extended Cessation Treatment for Teen Smokers

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00459953
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 141
• Location: 1
• Arms: 2
• Duration (Months): 58
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence	Drug: Extended treatment	Phase 2/Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extended Cessation Treatment for Teen Smokers
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extended treatment extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy	Drug: Extended treatment; All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.; Other Names: CBT nicotine patch
No Intervention: Control group Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact

Outcome Measures

Primary Outcome Measures

1. Point Prevalence Abstinence [6 months]

   Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• National Institute on Drug Abuse (NIDA)
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Joel D Killen, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Joel D Killen, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT00459953
• Other Study ID Numbers: CA118035; R01CA118035; NCT01330069
• First Posted: Apr 13, 2007
• Last Update Posted: May 30, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Tobacco Use Disorder; Nicotine

Study Results

Participant Flow

Pre-assignment Detail	The enrollment number in the protocol section (141) differs from the number of participants started in the participant flow module (143) because 2 of those originally enrolled were discovered to be living in the same household and assigned to different treatments. Thus, they were excluded from analyses.

Arm/Group Title	Extended Treatment	Control Group
Arm/Group Description	extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.	All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
Period Title: Overall Study
STARTED	72	71
COMPLETED	71	70
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Extended Treatment	Control Group	Total
Arm/Group Description	extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.	All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact	Total of all reporting groups
Overall Participants	71	70	141
Age (Count of Participants)
<=18 years	71 100%	70 100%	141 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	28 39.4%	25 35.7%	53 37.6%
Male	43 60.6%	45 64.3%	88 62.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	47 66.2%	50 71.4%	97 68.8%
Not Hispanic or Latino	24 33.8%	20 28.6%	44 31.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	71 100%	70 100%	141 100%

Outcome Measures

1. Primary Outcome

Title	Point Prevalence Abstinence
Description	Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended Treatment	Control Group
Arm/Group Description	extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.	Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
Measure Participants	71	70
Number [participants]	15 21.1%	5 7.1%

Adverse Events

Arm/Group Title	Extended Treatment		Control Group
Arm/Group Description	extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training.		All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
All Cause Mortality
	Extended Treatment		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Extended Treatment		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	Extended Treatment		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/71 (31%)		22/70 (31.4%)
Gastrointestinal disorders
Nausea	12/71 (16.9%)	12	12/70 (17.1%)	12
General disorders
Lightheaded	11/71 (15.5%)	11	10/70 (14.3%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.