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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01791803
Other study ID # STOPP
Secondary ID
Status Completed
Phase N/A
First received February 12, 2013
Last updated May 17, 2017
Start date January 2006
Est. completion date May 2009

Study information

Verified date May 2017
Source North Shore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
hypnotherapy
One 90 minute session within 2 weeks of hospital discharge
Drug:
Nicotine
free one month supply after hospital discharge

Locations

Country Name City State
United States North Shore Medical Center Salem Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
North Shore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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