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Hypnosis for Smoking Relapse Prevention (HypnoRelapse)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770380
First Posted: October 10, 2008
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timothy Carmody, University of California, San Francisco
  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
Smoking Behavioral: behavioral relapse prevention counseling Other: hypnosis for relapse prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypnosis for Smoking Relapse Prevention

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Point prevalence smoking status at 9, 26 and 52 weeks [ Time Frame: one year ]
    Point prevalence smoking status during past 7 days


Secondary Outcome Measures:
  • continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously [ Time Frame: one year ]
    Reported continuous abstinence from smoking


Enrollment: 139
Study Start Date: June 2007
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypnosis for relapse prevention
The hypnosis intervention was conducted in two face-to-face visits with hypnosis recorded for home practice. Learning, practicing, and employing hypnotic skills in resisting the urge to smoke are core components of this intervention.
Other: hypnosis for relapse prevention
Hypnosis for relapse prevention conducted in two one-hour sessions
Other Name: hypnotherapy
Active Comparator: Behavioral relapse prevention counseling
In the behavioral relapse prevention counseling, participants were taught coping strategies for resisting the urge to smoke. This intervention focused on relapse prevention (i.e., maintenance stage of change) and was based on the theoretical concepts and treatment procedures advocated by Marlatt and Gordon and recent smoking relapse data.
Behavioral: behavioral relapse prevention counseling
Behavioral relapse prevention counseling conducted in two one-hour sessions
Other Name: relapse prevention

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770380


Locations
United States, California
Veterans Affairs Medical Center, 4150 Clement Street
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Timothy P Carmody, PhD University of California, San Francisco
  More Information

Responsible Party: Timothy Carmody, Health Sciences Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00770380     History of Changes
Other Study ID Numbers: 16RT-0074
18109-557309 ( Other Identifier: TRDRP )
First Submitted: October 9, 2008
First Posted: October 10, 2008
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Timothy Carmody, University of California, San Francisco:
smoking