Phase 2
N=38
Treating Smokers With Mental Illness
Smoking Cessation · Cigarette Smoking · Schizophrenia · Psychotic Disorders · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03822416 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: 7-Day Point Prevalence Abstinence — 5; 3; 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nicotine patch (Drug); Nicotine lozenge (Drug); Therapy (Behavioral); Information (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-Day Point Prevalence Abstinence |
5; 3; 4; 5 | — |
| SECONDARY Quit Attempts |
13; 7; 18; 10 | — |
| SECONDARY Smoking Reduction |
5.6; 11.59; 4.84; 8.03 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03822416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.