NCT00770380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

October 9, 2008

Last Update Submit

March 7, 2022

Conditions

Keywords

smoking

Outcome Measures

Primary Outcomes (1)

  • Point prevalence smoking status at 9, 26 and 52 weeks

    Point prevalence smoking status during past 7 days

    one year

Secondary Outcomes (1)

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

    one year

Study Arms (2)

Hypnosis for relapse prevention

EXPERIMENTAL

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

Behavioral relapse prevention counseling

ACTIVE COMPARATOR

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

Interventions

Behavioral relapse prevention counseling conducted in two one-hour sessions

Also known as: relapse prevention
Behavioral relapse prevention counseling

Hypnosis for relapse prevention conducted in two one-hour sessions

Also known as: hypnotherapy
Hypnosis for relapse prevention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • currently smoking at least 5/cigarettes per day during the past week
  • willingness to participate and give informed consent
  • aged 18 and above

You may not qualify if:

  • contraindications to nicotine replacement
  • pregnancy, lactation
  • unstable psychiatric disorders
  • current (last 3 months)substance use disorder
  • terminal illness
  • current use of smoking cessation medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center, 4150 Clement Street

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Secondary PreventionHypnosis

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public HealthMind-Body TherapiesComplementary TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Timothy P Carmody, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

June 1, 2007

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations