Clinical trial NCT00770380: Hypnosis for Smoking Relapse Prevention
Official title: Hypnosis for Smoking Relapse Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Point prevalence smoking status at 9, 26 and 52 weeks
timeFrame: one year
Secondary outcomes:
measure: continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously
timeFrame: one year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center, 4150 Clement Street
state: California
Study officials:
affiliation: University of California, San Francisco
name: Timothy P Carmody, PhD
role: PRINCIPAL_INVESTIGATOR
References: