Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

NCT01791803 | Completed Results

• 1 other identifier: STOPP
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.

Conditions

Smoking Cessation

Keywords

Smoking cessation; Tobacco abstinence; hypnotherapy; Nicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

• Abstinence From Smoking

  Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers.

  at 26 weeks after hospitalization

Secondary Outcomes (2)

• Smoking Cessation

  at 12 weeks after hospitalization

• Smoking Abstinence Rate at 12 and 26 Weeks

  12 weeks and 26 weeks after hospital discharge

Study Arms (4)

Hypnotherapy

EXPERIMENTAL

Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.

Behavioral: hypnotherapy

Nicotine Replacement Therapy

EXPERIMENTAL

Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.

Drug: Nicotine

Hypnotherapy and Nicotine replacement

EXPERIMENTAL

The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.

Behavioral: hypnotherapy; Drug: Nicotine

Self-Quit group

NO INTERVENTION

Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.

Interventions

hypnotherapy BEHAVIORAL

One 90 minute session within 2 weeks of hospital discharge

Also known as: hypnosis

Hypnotherapy; Hypnotherapy and Nicotine replacement

Nicotine DRUG

free one month supply after hospital discharge

Also known as: Nicotine replacement therapy

Hypnotherapy and Nicotine replacement; Nicotine Replacement Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients with a Cardiopulmonary admission.

You may not qualify if:

• Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.

Sponsors & Collaborators

• North Shore Medical Center: lead

Study Sites (1)

North Shore Medical Center

Salem, Massachusetts, 01970, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Hypnosis; Nicotine; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Drug Therapy

Limitations and Caveats

Comparing two vastly different modalities such as hypnosis and NRT represented a randomizing challenge, as participants and researchers could not be blinded to interventions.

Results Point of Contact

• Title: Dr. Faysal M. Hasan
• Organization: North Shore Medical Center

fhasan@partners.org

978-741-1200

Study Officials

• Faysal Hasan, M.D.

  North Shore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Tobacco Prevention Service

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: January 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)