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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00770380 |
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.
Condition | Intervention | Phase |
---|---|---|
Smoking |
Behavioral: behavior relapse prevention counseling Other: hypnosis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Hypnosis for Smoking Relapse Prevention |
Estimated Enrollment: | 260 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
hypnosis
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Other: hypnosis
two one-hour sessions
|
2: Active Comparator
behavioural relapse prevention counseling
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Behavioral: behavior relapse prevention counseling
two one-hour sessions
|
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 couneling phone calls on their quit date and after relapse prevention treatment.
Outcomes for the two study arms will be compared by asssessing biochemcially-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 attemps to quit again if relapse occurs.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carol L Duncan, MPH | (415)221-4810 ext 4805 | carol.duncan2@va.gov |
Contact: Joy Huggins, MA | (415)221-4810 ext 4850 | joy.huggins@va.gov |
United States, California | |
Veterans Affairs Medical Center, 4150 Clement Street | Recruiting |
San Francisco, California, United States, 94121 | |
Contact: Carol L Duncan, MPH 415-221-4810 ext 4805 carol.duncan2@va.gov | |
Contact: Joy Huggins, MA (415)221-4810 ext 4850 joy.huggins@va.gov | |
Principal Investigator: Timothy P Carmody, Ph.D |
Principal Investigator: | Timothy P Carmody, PhD | University of California, San Francisco |
Responsible Party: | University of California Office of the Presidnet Specila Programs ( Joan Kaiser, Contracts and Grants ) |
Study ID Numbers: | 16RT-0074, 18109-557309 |
Study First Received: | October 9, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00770380 History of Changes |
Health Authority: | United States: Institutional Review Board |
smoking |
Smoking |
Habits Smoking |