Hypnosis for Smoking Relapse Prevention

Smoking Clinical Trial

— HypnoRelapse  

Official title:

Hypnosis for Smoking Relapse Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770380
• Other study ID #: 16RT-0074
• Secondary ID: 18109-557309
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Smoking

Intervention

Behavioral:
• behavioral relapse prevention counseling
Behavioral relapse prevention counseling conducted in two one-hour sessions

Other:
• hypnosis for relapse prevention
Hypnosis for relapse prevention conducted in two one-hour sessions

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center, 4150 Clement Street	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence smoking status at 9, 26 and 52 weeks	Point prevalence smoking status during past 7 days	one year
Secondary	continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously	Reported continuous abstinence from smoking	one year