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Completed

NCT Number: NCT00770380

Hypnosis for Smoking Relapse Prevention

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Medical Center, 4150 Clement Street

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral relapse prevention counseling

Behavioral

Behavioral relapse prevention counseling conducted in two one-hour sessions

Other names: relapse prevention

hypnosis for relapse prevention

Other

Hypnosis for relapse prevention conducted in two one-hour sessions

Other names: hypnotherapy

Primary outcomes

  1. Point prevalence smoking status at 9, 26 and 52 weeks

    Time frame: one year

    Point prevalence smoking status during past 7 days

Secondary outcomes

  1. continuous quitting as measured by reported non-smoking at 9, 26 and 52 weeks continuously

    Time frame: one year

    Reported continuous abstinence from smoking

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: HypnoRelapse

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2008
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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