Smoking Cessation After Hospitalization for a Cardiopulmonary Illness (STOPP)

Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: hypnotherapy; Drug: Nicotine

Detailed Description

Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Salem, Massachusetts, United States, 01970
      • North Shore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized patients with a Cardiopulmonary admission.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotherapy; 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; One 90 minute session within 2 weeks of hospital discharge; Other Names: hypnosis
Experimental: Nicotine Replacement Therapy; 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; free one month supply after hospital discharge; Other Names: Nicotine replacement therapy
Experimental: Hypnotherapy and Nicotine replacement; 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; One 90 minute session within 2 weeks of hospital discharge; Other Names: hypnosis; Drug: Nicotine; free one month supply after hospital discharge; Other Names: Nicotine replacement therapy
No Intervention: Self-Quit group; Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers.	at 12 weeks after hospitalization
Smoking Abstinence Rate at 12 and 26 Weeks	Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.	12 weeks and 26 weeks after hospital discharge

Collaborators and Investigators

• Sponsor: North Shore Medical Center
• Investigators: Principal Investigator: Faysal Hasan, M.D., North Shore Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Smoking cessation; hypnotherapy; Nicotine replacement therapy; Tobacco abstinence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: STOPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: published in: Complementary Therapies in Medicine 2014: 22: 1-8.