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Intervening to Promote Tobacco Cessation Following Psychiatric Hospitalization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05672914
Recruitment Status : Recruiting
First Posted : January 5, 2023
Last Update Posted : May 8, 2024
Sponsor:
Collaborators:
Ascension Seton Shoal Creek
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Richard A. Brown, University of Texas at Austin

Brief Summary:

Cigarette smoking is the leading cause of death and disability in the United States. People with psychiatric disorders consume almost half (44.3%) of all cigarettes smoked in the U.S. and have life spans more than 20 years shorter than the general population. Effective quit smoking treatments for people with psychiatric disorders are sorely needed.

When patients are hospitalized for a psychiatric disorder, they are not allowed to smoke. This enforced period of no smoking creates what professionals call "a teachable moment". It provides an excellent opportunity to discuss the prospect of staying quit once the individual leaves the hospital.

In ongoing research, the investigators have developed and tested a Sustained Care quit smoking intervention for smokers engaged in a psychiatric hospitalization. The intervention includes: 1) a professionally-led, motivational counseling session to encourage quitting smoking and increase awareness about available quit smoking resources, 2) a referral to the Texas Tobacco Quitline for phone-based, quit smoking counseling, and 3) an offer of 8 weeks of nicotine patches after leaving the hospital. Findings from a recently completed clinical trial provide strong support for this Sustained Care intervention.

Aims in the current project are to develop and test a tablet computer-based, motivational counseling intervention that does not require a trained professional counselor. The goal is to conduct a clinical trial to demonstrate the effectiveness of this tablet-based, Sustained Care intervention for smokers engaged in psychiatric hospitalization. As before, the same quit smoking resources (Quitline and nicotine patches) will be provided upon hospital discharge. If successful, next steps will involve plans to implement this quit smoking intervention in psychiatric hospitals throughout Texas, in order to reduce the burden caused by tobacco-related cancers among the citizens of Texas.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Tablet-based sustained care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervening to Promote Tobacco Cessation Following Psychiatric Hospitalization
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tablet-based Sustained Care
Intervention to support sustained smoking cessation.
Behavioral: Tablet-based sustained care
A tablet-based motivational-interviewing intervention, tailored specifically to smokers with psychiatric disorders, to motivate the use of evidence-based tobacco treatment and cessation in cigarette smokers upon discharge from an inpatient psychiatric hospitalization. In addition, participants will receive standard hospital tobacco care (see Usual Care Arm).

No Intervention: Usual Care
Standard hospital care: : A brief (5-10 min.) tobacco education session from a hospital nurse, along with educational materials about quitting and a quitline brochure.



Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: 1, 3, and 6 months after hospital discharge ]
    Binomial outcome of continued smoking abstinence vs. relapse modeled over time and controlling for gender and magnitude of initial nicotine dependence


Secondary Outcome Measures :
  1. Number of quit attempts [ Time Frame: First month following hospital discharge ]
    Count of attempts to quit smoking



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients above the age of 18 capable of providing informed consent
  • Current smoker (at least 5 cigarettes/day when not hospitalized)
  • Willing and able to provide informed consent, attend all study visits, and comply with the protocol

Exclusion Criteria:

  • Mini-Mental State Examination (MMSE) score < 24
  • Current diagnosis of dementia or other cognitive impairment that would limit study participation
  • Inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures
  • Current diagnosis of a (non-nicotine) substance use disorder requiring detoxification
  • No access to or inability to communicate by phone, or no stable mailing address
  • Planned discharge to institutional care (e.g., nursing home, long-term rehabilitation, jail, etc.)
  • Medical contraindication to nicotine patch use
  • Currently pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05672914


Contacts
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Contact: Richard Brown, Ph.D. +1 512 232-6832 brown2@utexas.edu

Locations
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United States, Texas
Ascension Shoal Creek Recruiting
Austin, Texas, United States, 78731
Sponsors and Collaborators
University of Texas at Austin
Ascension Seton Shoal Creek
Cancer Prevention Research Institute of Texas
Investigators
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Principal Investigator: Richard Brown, Ph.D. The University of Texas at Austin
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Responsible Party: Richard A. Brown, Research Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT05672914    
Other Study ID Numbers: STUDY00002552
RP220203 ( Other Grant/Funding Number: Cancer Prevention & Research Institute of Texas )
First Posted: January 5, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No