Joel D. Killen, Ph.D.
Abstract:
400 adult smokers will be randomized. Our primary goal is to examine the
effectiveness of a multi-factor maintenance treatment strategy in promoting
longer-term smoking abstinence. All smokers will receive the same “Acute
Phase Treatment” that combines nicotine patch, bupropion
and intensive self-regulatory skills training. Nicotine patches will be
provided for 8 weeks and bupropion and skills
training will be provided for 9 weeks. Participants will then enter a “Maintenance
Treatment Phase” during which half (n=200) will receive three
individualized relapse prevention training sessions spread over a 12 week
period. They will also receive 12 weeks of self-administered relapse prevention
administered via written treatment modules. Finally, telephone counseling will
be provided in conjunction with an Interactive Voice Response system (IVR)
enabling early detection of smoking “slips” and rapid response by treatment
staff. The other half (n=200) will be assigned to a control condition that
consists of three counselor-led sessions of “supportive therapy” spread over a
12 week period. Primary hypothesis: smokers randomized to the skills training +
IVR + Telephone counseling maintenance treatment will have a higher prolonged
abstinence rate at 12mo follow-up than participants in the “control”
maintenance treatment. With 200 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. We also propose to
utilize DNA samples collected from participants in combination with single
nucleotide polymorphism (SNP) genomic databases to identify new genetic markers
for treatment response and side effects.
Specific Aims:
The proposed study will address several important gaps in our knowledge
of effective smoking cessation treatment.