STOPP: Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

• Sponsor: North Shore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01791803
• Collaborator: (none)
• Enrollment: 164
• Location: 1
• Arms: 4
• Duration (Months): 40
• Patients Per Site Per Month: 4.1

Study Details

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	N/A

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
• 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: Jan 1, 2006
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 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 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.

Outcome Measures

Primary Outcome Measures

1. Abstinence From Smoking [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 [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 [12 weeks and 26 weeks after hospital discharge]

   Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 15, 2013
• Last Update Posted: May 19, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Faysal M. Hasan, MD, Director, Tobacco Prevention Service, North Shore Medical Center: Smoking cessation; Tobacco abstinence; hypnotherapy; Nicotine replacement therapy
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Arm/Group Title	Hypnotherapy	Nicotine Replacement Therapy	Hypnotherapy and Nicotine Replacement	Self-Quit Group
Arm/Group Description	Patients admitted with a cardiopulmonary illness will receive 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 will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. Nicotine: free one month supply after hospital discharge	The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Period Title: Overall Study
STARTED	41	41	40	42
COMPLETED	41	39	38	37
NOT COMPLETED	0	2	2	5

Baseline Characteristics

Arm/Group Title	Hypnotherapy	Nicotine Replacement Therapy	Hypnotherapy and Nicotine Replacement	Self-Quit Group	Total
Arm/Group Description	Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.	Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.	patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.	Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.	Total of all reporting groups
Overall Participants	41	41	40	42	164
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	41 100%	40 100%	42 100%	164 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.0 (10.6)	55.3 (12.2)	54.4 (8.9)	56.0 (10.7)	55.17 (1.4)
Sex: Female, Male (Count of Participants)
Female	25 61%	18 43.9%	14 35%	16 38.1%	73 44.5%
Male	16 39%	23 56.1%	26 65%	26 61.9%	91 55.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	38 92.7%	32 78%	31 77.5%	36 85.7%	137 83.5%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 7.3%	9 22%	9 22.5%	6 14.3%	27 16.5%
Region of Enrollment (participants) [Number]
United States	41 100%	41 100%	40 100%	42 100%	164 100%
Years of education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13 (2)	12.6 (2)	13.2 (1.8)	13.2 (1.9)	13 (1.9)
Number of cigarettes smoked (Cigarettes smoked /day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cigarettes smoked /day]	19.8 (12.6)	21.2 (12.6)	20.5 (9.3)	15 (10)	19.12 (11.12)
Total years of smoking (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.5 (12.7)	34.2 (14.4)	34.3 (11.7)	33.2 (10.8)	34.55 (12.4)
Living with a smoker (Count of Participants)
Count of Participants [Participants]	18 43.9%	16 39%	13 32.5%	14 33.3%	61 37.2%
Admitted with Cardiac Diagnosis (Count of Participants)
Count of Participants [Participants]	26 63.4%	25 61%	22 55%	27 64.3%	100 61%
Lost to Follow up (Considered non-quitters) (Count of Participants)
Count of Participants [Participants]	14 34.1%	12 29.3%	13 32.5%	17 40.5%	56 34.1%

Outcome Measures

1. Primary Outcome

Title	Abstinence From Smoking
Description	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.
Time Frame	at 26 weeks after hospitalization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypnotherapy	Nicotine Replacement Therapy	Hypnotherapy and Nicotine Replacement	Self-Quit Group
Arm/Group Description	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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Patients received 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. Nicotine: free one month supply after hospital discharge	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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Measure Participants	41	39	38	37
Number [percentage of participants]	15 36.6%	7 17.1%	13 32.5%	10 23.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnotherapy, Nicotine Replacement Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 1.1 to 11.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Nicotine Replacement Therapy, Hypnotherapy and Nicotine Replacement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.04 to 9.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Smoking Cessation
Description	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.
Time Frame	at 12 weeks after hospitalization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypnotherapy	Nicotine Replacement Therapy	Hypnotherapy and Nicotine Replacement	Self-Quit Group
Arm/Group Description	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 will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge	Patients received 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. Nicotine: free one month supply after hospital discharge	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. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge	patients were given brief counseling during hospitalization and were not be contacted until 26 weeks after hospitalization.
Measure Participants	41	39	38	37
Count of Participants [Participants]	18 43.9%	11 26.8%	18 45%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnotherapy, Nicotine Replacement Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; 0.8 to 6.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Nicotine Replacement Therapy, Hypnotherapy and Nicotine Replacement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 1.2 to 10
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Smoking Abstinence Rate at 12 and 26 Weeks
Description	Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.
Time Frame	12 weeks and 26 weeks after hospital discharge

Outcome Measure Data

Analysis Population Description

Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms.

Arm/Group Title	Smoking Abstinence Rates at 12 and 26 Weeks
Arm/Group Description	Smoking status at follow-up time at 12 and 26 weeks by diagnosis status (cardiac vs. pulmonary)
Measure Participants	155
% Quit rate for cardiac diagnosis at 12 weeks	52.1
% Quit rate for pulmonary diagnosis at 12 weeks	20
% Quit rate for cardiac diagnosis at 26 weeks	34
% quit rate for pulmonary diagnosis at 26 weeks	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnotherapy
	Comments	Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Hypnotherapy
	Comments	Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	12 and 26 weeks after hospital discharge
Arm/Group Title	Hypnotherapy		Nicotine Replacement Therapy		Hypnotherapy and Nicotine Replacement		Self-Quit Group
Arm/Group Description	patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization		Patients receiving a free months supply of nicotine		Patients receiving hypnotherapy and nicotine supply		patient who decided to quit on their own
All Cause Mortality
	Hypnotherapy		Nicotine Replacement Therapy		Hypnotherapy and Nicotine Replacement		Self-Quit Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Hypnotherapy		Nicotine Replacement Therapy		Hypnotherapy and Nicotine Replacement		Self-Quit Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)		0/38 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Hypnotherapy		Nicotine Replacement Therapy		Hypnotherapy and Nicotine Replacement		Self-Quit Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)		0/38 (0%)		0/37 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.