Hypnosis for Smoking Relapse Prevention

NCT ID: NCT00770380

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-06-30

Brief Summary

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.

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

hypnosis for relapse prevention

Intervention Type: OTHER

Hypnosis for relapse prevention conducted in two one-hour sessions

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.

Group Type: ACTIVE_COMPARATOR

behavioral relapse prevention counseling

Intervention Type: BEHAVIORAL

Behavioral relapse prevention counseling conducted in two one-hour sessions

Interventions

behavioral relapse prevention counseling

Behavioral relapse prevention counseling conducted in two one-hour sessions

Intervention Type: BEHAVIORAL

hypnosis for relapse prevention

Hypnosis for relapse prevention conducted in two one-hour sessions

Intervention Type: OTHER

Other Intervention Names

relapse prevention; hypnotherapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy P Carmody, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Veterans Affairs Medical Center, 4150 Clement Street

San Francisco, California, United States

Countries

United States

Other Identifiers

18109-557309

Identifier Type: OTHER

Identifier Source: secondary_id

16RT-0074

Identifier Type: -

Identifier Source: org_study_id