Hypnosis for Smoking Relapse Prevention (HypnoRelapse)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Carmody, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00770380
First received: October 9, 2008
Last updated: September 15, 2011
Last verified: September 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypnosis for Smoking Relapse Prevention

Resource links provided by NLM:


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 ]

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: 1
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
two one-hour sessions
Other Name: hypnotherapy
Active Comparator: 2
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: behavior relapse prevention counseling
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 9, 2008
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
smoking

ClinicalTrials.gov processed this record on August 28, 2014