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Hypnosis for Smoking Relapse Prevention (HypnoRelapse)
This study is currently recruiting participants.
Verified by University of California, San Francisco, October 2008
First Received: October 9, 2008   No Changes Posted
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00770380
  Purpose

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

MedlinePlus related topics: Smoking
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Hypnosis for Smoking Relapse Prevention

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Point prevalence smoking status at 9, 26 and 52 weeks [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously [ Time Frame: one year ] [ Designated as safety issue: No ]

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
Other: hypnosis
two one-hour sessions
2: Active Comparator
behavioural relapse prevention counseling
Behavioral: behavior relapse prevention counseling
two one-hour sessions

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770380

Contacts
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

Locations
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            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Timothy P Carmody, PhD University of California, San Francisco
  More Information

No publications provided

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

Keywords provided by University of California, San Francisco:
smoking

Study placed in the following topic categories:
Smoking

Additional relevant MeSH terms:
Habits
Smoking

ClinicalTrials.gov processed this record on May 06, 2009