Smoking Cessation After Hospitalization for a Cardiopulmonary Illness (STOPP)

• ClinicalTrials.gov Identifier: NCT01791803
• Recruitment Status: Completed
• First Posted: February 15, 2013
• Results First Posted: May 19, 2017
• Last Update Posted: May 19, 2017
• Sponsor: North Shore Medical Center
• Information provided by (Responsible Party): Faysal M. Hasan, MD, North Shore Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: hypnotherapy; Drug: Nicotine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients
• Study Start Date: January 2006
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

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 Name: 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 Name: 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 Name: hypnosis; Drug: Nicotine; free one month supply after hospital discharge; Other Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Abstinence From Smoking [ Time Frame: at 26 weeks after hospitalization ]
   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.

Secondary Outcome Measures :

1. Smoking Cessation [ Time Frame: at 12 weeks after hospitalization ]
   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.
2. Smoking Abstinence Rate at 12 and 26 Weeks [ Time Frame: 12 weeks and 26 weeks after hospital discharge ]
   Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

North Shore Medical Center

Salem, Massachusetts, United States, 01970

Sponsors and Collaborators

North Shore Medical Center

Investigators

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

More Information

• Responsible Party: Faysal M. Hasan, MD, Director, Tobacco Prevention Service, North Shore Medical Center
• ClinicalTrials.gov Identifier: NCT01791803
• Other Study ID Numbers: STOPP
• First Posted: February 15, 2013
• Results First Posted: May 19, 2017
• Last Update Posted: May 19, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: published in: Complementary Therapies in Medicine 2014: 22: 1-8.

Keywords provided by Faysal M. Hasan, MD, North Shore Medical Center:

Smoking cessation; Tobacco abstinence; hypnotherapy; Nicotine replacement therapy

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action