Smoking CessationSTOPPNCT01791803
Smoking Cessation After Hospitalization for a Cardiopulmonary Illness
A study testing hypnotherapy and Nicotine in people with Smoking Cessation, run by North Shore Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- hypnotherapy and Nicotine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with a Cardiopulmonary admission.
Who cannot join
- Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore Medical Center
Salem, Massachusetts, 01970
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- hypnotherapy, Nicotine
- Keywords
- Smoking cessation, Tobacco abstinence, hypnotherapy, Nicotine replacement therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnotherapyBehavioural
Also called hypnosis
One 90 minute session within 2 weeks of hospital discharge
NicotineDrug
Also called Nicotine replacement therapy
free one month supply after hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 26 weeks after hospitalization
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks and 26 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Shore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faysal M. Hasan, MD, North Shore Medical Center
- Investigators
- Faysal Hasan, M.D., Principal investigator, North Shore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791803
- Sponsor's protocol ID
- STOPP
- Acronym
- STOPP
- Status last verified
- May 2017
- First submitted
- 12 Feb 2013
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: published in: Complementary Therapies in Medicine 2014: 22: 1-8.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01791803
- Acronym / sponsor ID
- STOPP / STOPP
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Tobacco abstinence, hypnotherapy, Nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- North Shore Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Experimental | Behavioral: hypnotherapyPatients 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. |
| Nicotine Replacement Therapy | Experimental | Drug: NicotinePatients 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. |
| Hypnotherapy and Nicotine replacement | Experimental | Behavioral: hypnotherapy, Drug: NicotineThe group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge. |
| Self-Quit group | No intervention | –Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with a Cardiopulmonary admission.
Key exclusion criteria (1 listed)
- Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnotherapyAlso: hypnosisOne 90 minute session within 2 weeks of hospital discharge | Behavioural | Hypnotherapy, Hypnotherapy and Nicotine replacement |
| NicotineAlso: Nicotine replacement therapyfree one month supply after hospital discharge | Drug | Hypnotherapy and Nicotine replacement, Nicotine Replacement Therapy |
Primary outcome
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.
2 secondary outcomes
Smoking Cessation
Time frame: at 12 weeks after hospitalization
Smoking Abstinence Rate at 12 and 26 Weeks
Time frame: 12 weeks and 26 weeks after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. published in: Complementary Therapies in Medicine 2014: 22: 1-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faysal Hasan, M.D. principal investigator
North Shore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnotherapy and Nicotine in people with Smoking Cessation, run by North Shore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence From Smoking (time frame: at 26 weeks after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.