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Smoking CessationNCT05672914

Intervening to Promote Tobacco Cessation Following Psychiatric Hospitalization

A study testing Tablet-based sustained care in people with Smoking Cessation, run by University of Texas at Austin at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Tablet-based sustained care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
10 Aug 2023to Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Richard Brown, Ph.D. contact

+1 512 232-6832

brown2@utexas.edu

United States1 site, 1 recruiting
  • Ascension Shoal Creek

    Austin, Texas, 78731

    Recruiting

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

Cigarette smoking is the leading cause of death in the U.S., resulting in over 480,000 deaths annually. Individuals with any mental illness constitute 18.9% of the U.S. adult population and are estimated to consume almost half (44.3%) of all cigarettes smoked in the U.S. Indeed, individuals with psychiatric disorders smoke cigarettes at disproportionately higher rates and bear an especially large proportion of the tobacco morbidity and mortality burden, with life spans more than 20 years shorter than the general population. People with mental disorders are at significantly elevated risk of malignancies of the brain and central nervous system and respiratory system, including cancers of the lung and bronchus, likely due to cigarette smoking. Yet smokers in inpatient psychiatric settings are rarely encouraged to quit smoking or provided referrals for cessation treatment on discharge, despite growing evidence that smoking cessation may improve psychiatric symptoms long-term and that many smokers with psychiatric disorders want to quit smoking.

Given the disproportionately high rates of smoking and related cancer morbidity and mortality among those with psychiatric disorders, the integration of effective smoking cessation interventions into psychiatric treatment settings is a public health priority. As no tobacco use is allowed on psychiatric hospital units and smoking patterns are disrupted, the inpatient setting in particular offers an ideal opportunity to initiate smoking cessation by capitalizing on abstinence already achieved during hospitalization. This clinical trial attempts to capitalize upon this largely underutilized "teachable moment" by framing a cessation effort as a continuation of what has already begun, i.e., continued movement toward total abstinence.

It was demonstrated, in a randomized controlled trial (RCT) of 342 adult smokers receiving inpatient psychiatric care, that an in-person, motivational interviewing (MI)-based, Sustained Care (SusC) intervention (including tobacco quitline referral and nicotine patches) vs. Usual Care (UC) resulted in significantly increased smoking cessation treatment utilization and significantly higher rates of confirmed smoking abstinence at 6-months post-hospital discharge. While successful in increasing treatment utilization and confirmed abstinence rates after discharge, this in-person, 40-minute MI intervention would be challenging to implement broadly in psychiatric hospitals across the State of Texas. Inexpensive and readily disseminable options are needed.

The investigators plan to accomplish the objectives of this application by pursuing the following three specific aims. First, to develop a tablet-based (iPad) intervention (named "Tablet-delivered Sustained Care Smoking Cessation Intervention or "T-SusC") intended to motivate the use of evidence-based tobacco treatment and cessation in cigarette smokers upon discharge from an inpatient psychiatric hospitalization. Second, to conduct a Phase III efficacy trial, comparing the effects of T-SusC to Usual Care (UC). We hypothesize that: 2a) T-SusC (vs. UC) will result in higher rates of confirmed 7-day point prevalence abstinence at 1-, 3- and 6-months post-hospital discharge, and 2b) T-SusC (vs. UC) will result in higher rates of utilization of tobacco quitline counseling and smoking cessation medication. Third, to examine potential mechanisms underlying intervention effects. We hypothesize that: 3a) pre-post intervention increases in concerns about smoking and motivation to quit smoking, decreases in concerns about quitting smoking exacerbating psychiatric symptoms and greater satisfaction with intervention content will mediate efficacy and 2b) utilization rates of tobacco quitline engagement and cessation medication use will mediate efficacy. Finally, the effect of T-SusC (vs. UC) on psychiatric symptoms over the course of the 6-month follow-up period will be examined.

The rationale for the proposed research is demonstrated by findings from the prior RCT, showing that many smokers in psychiatric treatment are interested in quitting smoking, and armed with the knowledge that quitting smoking does not jeopardize psychiatric treatment and may improve psychiatric symptoms in the long run, can be motivated to engage in smoking cessation counseling and medication use with good success. This project is expected to result in the development of a brief, cost-effective tablet-based (iPad) MI intervention that will produce increased rates of smoking cessation and increased utilization of tobacco quitline and cessation medication following psychiatric inpatient treatment. These results are expected to have an important positive impact that will move the field closer to the long-term goal of dissemination and integration of the T-SusC into inpatient psychiatric treatment programs throughout Texas, to motivate tobacco cessation in psychiatric patients who smoke.

Being tested
Tablet-based sustained care
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tablet-based sustained careBehavioural

    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).

Study groups in NCT05672914
Study groupRoleWhat they receive
Tablet-based Sustained CareExperimentalIntervention to support sustained smoking cessation.
Receives: Behavioral: Tablet-based sustained care
Usual CareNo interventionStandard hospital care: : A brief (5-10 min.) tobacco education session from a hospital nurse, along with educational materials about quitting and a quitline brochure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking cessation

    Binomial outcome of continued smoking abstinence vs. relapse modeled over time and controlling for gender and magnitude of initial nicotine dependence

    Measured: 1, 3, and 6 months after hospital discharge

Secondary outcomes (1)
  1. Number of quit attempts

    Count of attempts to quit smoking

    Measured: First month following hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start10 Aug 2023
  3. Primary completionMay 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672914
Sponsor's protocol ID
STUDY00002552
Other IDs
RP220203
Status last verified
May 2024
First submitted
21 Dec 2022
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tablet-based sustained care in people with Smoking Cessation, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Richard Brown, Ph.D. (+1 512 232-6832, brown2@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking cessation (time frame: 1, 3, and 6 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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