A Phase 2 interventional study of Nicotine patch and Nicotine lozenge in Smoking Cessation, Cigarette Smoking and Schizophrenia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
Drug: Nicotine patch · Drug: Nicotine lozenge · Behavioral: Therapy · Other: Information
Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.
Other: Information
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 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
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
Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
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.
Time frame: 8 weeks and 6 months post baseline
Quit Attempts
To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.
Time frame: 8 weeks and 6 months post baseline
Smoking Reduction
To determine the mean reduction in cigarettes per day in the intervention and control conditions.
Time frame: 8 weeks and 6 months post baseline
| Milestone | Intervention | Control |
|---|---|---|
| Started | 19 | 19 |
| Completed | 18 | 18 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Participants | Intervention | Control |
|---|---|---|
| 8 Weeks | 5 | 3 |
| 6 Months | 4 | 5 |
To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.
| Participants | Intervention | Control |
|---|---|---|
| 8 Weeks | 13 | 7 |
| 6 Months | 18 | 10 |
To determine the mean reduction in cigarettes per day in the intervention and control conditions.
| cigarettes per day | Intervention | Control |
|---|---|---|
| 8 Weeks | 5.6 ± 7.04 | 11.59 ± 4.15 |
| 6 Months | 4.84 ± 4.56 | 8.03 ± 3.23 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) |
| Control | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Event | Intervention | Control |
|---|---|---|
| increased coughing following smoking cessationRespiratory, thoracic and mediastinal disorders | 1/19 | 0/19 |
| Age, Categorical(Participants) | Intervention | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 19 | 37 |
| >=65 years | 1 | 0 | 1 |
| Sex/Gender, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 6 | 12 | 18 |
| Male | 11 | 7 | 18 |
| Other | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 3 | 11 |
| White | 8 | 10 | 18 |
| More than one race | 1 | 6 | 7 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 19 | 19 | 38 |
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