Smoking CessationPhase 2NCT03822416
Treating Smokers With Mental Illness
A Phase 2 study testing Nicotine patch, Nicotine lozenge and Therapy in people with Smoking Cessation and Cigarette Smoking, run by University of Minnesota at 1 site in United States.
Trial summary
This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Cigarette Smoking, Schizophrenia
- What is being tested?
- Nicotine patch, Nicotine lozenge and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 4 May 2020
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have a severe mental illness diagnosis
- be a daily smoker
- be willing to reduce the number of cigarettes smoked per day leading to a quit attempt
- want to try to quit smoking
- be willing to use nicotine replacement therapy
- be able to communicate in English
Who cannot join
- anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months
- pregnancy
- taking Chantix or Clozapine
- having a terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Treating Tobacco Dependence in Smokers With Severe Mental Illness
This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.
Read the detailed description
At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.
- Conditions
- Smoking Cessation, Cigarette Smoking, Schizophrenia, Psychotic Disorders, Major Depressive Disorder, Bipolar Disorder I
- Being tested
- Nicotine patch, Nicotine lozenge, Therapy, Information
- Keywords
- mental illness, tobacco treatment
- Medical subject headings
- Smoking Cessation, Cigarette Smoking, Schizophrenia, Psychotic Disorders, Depressive Disorder, Major, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use
Nicotine lozengeDrug
Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use
TherapyBehavioural
In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase
InformationOther
Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. Receives: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Therapy; Other: Information |
| Control | Other | Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. Receives: Other: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalence Abstinence
To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.
Measured: 8 weeks and 6 months post baseline
Secondary outcomes (2)
Quit Attempts
To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.
Measured: 8 weeks and 6 months post baseline
Smoking Reduction
To determine the mean reduction in cigarettes per day in the intervention and control conditions.
Measured: 8 weeks and 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Mar 2019
- Primary completion4 May 2020
- Study completion4 May 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, Brown University
- Responsible party
- Sponsor
- Investigators
- Harry Lando, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822416
- Sponsor's protocol ID
- SPH-2018-26854
- Status last verified
- May 2021
- First submitted
- 28 Jan 2019
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Busch AM, Nederhoff DM, Dunsiger SI, Japuntich SJ, Chrastek M, Adkins-Hempel M, Rinehart LM, Lando H. Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial. BMC Psychiatry. 2021 Feb 17;21(1):104. doi: 10.1186/s12888-021-03113-5.
PubMed 33593332
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Tobacco Dependence in Smokers With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT03822416
- Acronym / sponsor ID
- SPH-2018-26854
- Conditions
- Smoking Cessation, Cigarette Smoking, Schizophrenia, Psychotic Disorders, Major Depressive Disorder, Bipolar Disorder I
- Keywords
- mental illness, tobacco treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, Brown University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.
Detailed description
At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Nicotine patch, Drug: Nicotine lozenge, Behavioral: Therapy, Other: InformationIntervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. |
| Control | Other | Other: InformationControl group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have a severe mental illness diagnosis
- be a daily smoker
- be willing to reduce the number of cigarettes smoked per day leading to a quit attempt
- want to try to quit smoking
- be willing to use nicotine replacement therapy
Key exclusion criteria (4 listed)
- anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months
- pregnancy
- taking Chantix or Clozapine
- having a terminal illness
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 |
|---|---|---|
| Nicotine patchNicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use | Drug | Intervention |
| Nicotine lozengeNicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use | Drug | Intervention |
| TherapyIn-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase | Behavioural | Intervention |
| InformationInformation about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community | Other | Control, Intervention |
Primary outcome
7-Day Point Prevalence Abstinence
Time frame: 8 weeks and 6 months post baseline
To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.
2 secondary outcomes
Quit Attempts
Time frame: 8 weeks and 6 months post baseline
Smoking Reduction
Time frame: 8 weeks and 6 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33593332Busch AM, Nederhoff DM, Dunsiger SI, Japuntich SJ, Chrastek M, Adkins-Hempel M, Rinehart LM, Lando H. Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial. BMC Psychiatry. 2021 Feb 17;21(1):104. doi: 10.1186/s12888-021-03113-5.
- Individual participant dataSharing planned: No
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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.
Harry Lando, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine patch, Nicotine lozenge and Therapy in people with Smoking Cessation and Cigarette Smoking, run by University of Minnesota 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 6 inclusion and 4 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 25 May 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). 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?
7-Day Point Prevalence Abstinence (time frame: 8 weeks and 6 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822416, which also lists 1 linked publication.
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 25 May 2021.