Recruiting

Tobacco Cessation

Sponsor:

University of Texas at Austin

Code:

NCT05672914

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tablet-based sustained care

Study Details

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.

Conditions

Smoking Cessation

Study ID

NCT05672914

Start date

Aug 10, 2023

Status verified date

May, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tablet-based Sustained Care

Intervention to support sustained smoking cessation.

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.

Interventions

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).

Primary outcome measure

  • Smoking cessation [ Time Frame: 1, 3, and 6 months after hospital discharge ]

Central Contacts and Locations

Central contacts

Locations

Ascension Shoal Creek

Recruiting

Austin, Texas, United States, 78731

More Information

Sponsor

University of Texas at Austin

Last update posted

May 8, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2024-05-08.