Hypnosis for Smoking Relapse Prevention (HypnoRelapse)

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: hypnosis for relapse prevention; Behavioral: behavioral relapse prevention counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • Veterans Affairs Medical Center, 4150 Clement Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: relapse prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point prevalence smoking status at 9, 26 and 52 weeks	Point prevalence smoking status during past 7 days	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously	Reported continuous abstinence from smoking	one year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Timothy P Carmody, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 10, 2008

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: smoking
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 16RT-0074; 18109-557309 (Other Identifier: TRDRP)