Nicotine Dependence
Conditions
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.
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.
Interventions
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.
Sponsors
National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Extended Treatment 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. | 71 |
| Control Group 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 | 70 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | not analyzed-household member in study | 1 | 1 |
Baseline characteristics
| Characteristic | Extended Treatment | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 71 Participants | 70 Participants | 141 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants | 50 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 20 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 71 participants | 70 participants | 141 participants |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Male | 43 Participants | 45 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 71 | 22 / 70 |
| serious Total, serious adverse events | 0 / 72 | 0 / 71 |
Outcome results
Primary
Point Prevalence Abstinence
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Treatment | Point Prevalence Abstinence | 15 participants |
| Control Group | Point Prevalence Abstinence | 5 participants |