Smoking
Conditions
Keywords
smoking
Brief summary
A majority of smokers who quit return to smoking within three months of their quit date. This study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural counseling to promote maintenance of abstinence or relapse prevention in quitting smokers. The hypothesis is that hypnosis will be at least as effective as behavioral counseling in preventing relapse to smoking in smokers who are able to quit for at least three days.
Detailed description
We will enroll 520 current smokers in the study. All subjects will participate in an initial smoking cessation intervention involving brief counseling and nicotine replacement therapy. Participants who are able to achieve at least 3 consecutive days of abstinence will be randomized to one of two relapse prevention interventions. The participants in Study Arm 1 will receive a hypnosis intervention designed to facilitate relapse prevention. Participants in Study Arm 2 will participate in empirically-supported behavior relapse prevention counseling, utilizing the National Cancer Institute's Forever Free materials. Both interventions will be conducted in two 60-minute individual sessions scheduled one week apart in addition to counseling phone calls on their quit date and after relapse prevention treatment. Outcomes for the two study arms will be compared by assessing biochemically-validated point-prevalence smoking status at 9 weeks(end of treatment), 26 weeks and 52 weeks. Hypnosis for relapse prevention is designed to sustain the ex-smokers commitment to remain abstinent, to provide a review of behavioral skills to resist the temptations to smoke, and to encourage attempts to quit again if relapse occurs.
Interventions
BEHAVIORALbehavioral relapse prevention counseling
Behavioral relapse prevention counseling conducted in two one-hour sessions
OTHERhypnosis for relapse prevention
Hypnosis for relapse prevention conducted in two one-hour sessions
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* currently smoking at least 5/cigarettes per day during the past week * willingness to participate and give informed consent * aged 18 and above
Exclusion criteria
* contraindications to nicotine replacement * pregnancy, lactation * unstable psychiatric disorders * current (last 3 months)substance use disorder * terminal illness * current use of smoking cessation medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point prevalence smoking status at 9, 26 and 52 weeks | one year | Point prevalence smoking status during past 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously | one year | Reported continuous abstinence from smoking |
Countries
United States
Outcome results
None listed