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Sustained Care for Nicotine Addiction

N/A
Waitlist Available
Led By Nancy A. Rigotti, M.D.
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights

Study Summary

Smoking rates among individuals with psychiatric disorders are disproportionately higher than the general population. The majority of psychiatric hospitals ban smoking on hospital grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers in inpatient psychiatric settings are infrequently provided with referrals for cessation treatment on discharge (< 1 %) and most resume smoking upon discharge. Therefore, the integration of effective cessation interventions within the current mental health treatment system is a public health priority. The overall objective of this project is to adapt a Sustained Care (SusC) model to smokers with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted SusC intervention in real-world practice. We will test the hypothesis that, among smokers with SMI in inpatient psychiatric treatment (n = 422), SusC will result in significantly greater rates of cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a group that receives Usual Care (UC) about smoking cessation. Furthermore, we hypothesize that a higher proportion of SusC vs. UC patients will use evidence-based smoking cessation treatment (counseling and pharmacotherapy) in the month after discharge. We will also explore the effect of SusC on health and health care utilization in the 12 months post-discharge (psychiatric symptoms, psychiatric and medical hospital readmissions and emergency room visits) and the effectiveness of SusC on smoking abstinence in patient diagnostic subgroups. The expected outcome of this project is a demonstration of the effectiveness of a Sustained Care intervention for smoking cessation in individuals with severe mental illness (SMI) following psychiatric hospitalization. Future studies could extend these findings to individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall, this research would have a significant positive public health impact that will move us closer to the long-term goal of dissemination and integration of the Sustained Care model to increase smoking cessation and decrease smoking related morbidity and mortality in people with severe mental illness.

Eligible Conditions
  • Nicotine Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biochemically verified smoking abstinence via saliva cotinine
Secondary outcome measures
Proportion of patients who use smoking cessation medication or counseling following discharge
Other outcome measures
Emergency room visits, both psychiatric and medical
Hospital readmissions, both psychiatric and medical
Incremental cost effectiveness
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sustained CareExperimental Treatment1 Intervention
A 40-minute, in-hospital motivational counseling session about smoking cessation, 8 Interactive Voice Response (IVR) phone calls and/or texts over 90 days, including the possibility of a warm transfer to a telephone tobacco quit line and up to 8-weeks of free transdermal nicotine patches.
Group II: Usual CareActive Control1 Intervention
A brief 5-10 minute tobacco education session that all hospitalized smokers will receive, delivered by a hospital nurse. During this session, they will be provided with written handouts describing the stages of readiness for change in quitting, self-monitoring of smoking, self-management of smoking situations, relapse prevention, managing stress, other quitting tips and use of nicotine replacement therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sustained Care
2012
N/A
~1360

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
80,562 Total Patients Enrolled
1 Trials studying Nicotine Addiction
53 Patients Enrolled for Nicotine Addiction
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,688,727 Total Patients Enrolled
Nancy A. Rigotti, M.D.Principal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~43 spots leftby Apr 2025