Harm Reduction for Smokers With Mental Illness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

NCT03069482

Nicotine Addiction Serious Mental Illness

COMPLETED PHASE1

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

NCT05030272

Tobacco Use Disorder Mental Illness Recurring Major Depressive Disorder +4 more

COMPLETED NA

Helping Those With Mental Illness Quit Smoking

NCT01783912

Smoking Nicotine Dependence Mental Disorders

COMPLETED PHASE4

Electronic Decision Support Systems for Smokers With Severe Mental Illness

NCT01412866

Severe Mental Illness Nicotine Dependence Schizophrenia +1 more

COMPLETED NA

Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness

NCT01779440

Mental Illness Tobacco Smoking Psychotic Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E-cigarette provision only

Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study.

Group Type ACTIVE_COMPARATOR

E-cig Provision Only

Intervention Type OTHER

Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.

SWITCH IT

Participants randomized to this condition will receive a supply of e-cigarettes and behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study.

Group Type EXPERIMENTAL

SWITCH IT

Intervention Type BEHAVIORAL

Behavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore e-cigarette options based on availability, cost, and preferences during week 4 and week 6.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SWITCH IT

Behavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore e-cigarette options based on availability, cost, and preferences during week 4 and week 6.

Intervention Type BEHAVIORAL

E-cig Provision Only

Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Schizophrenia
* Bipolar disorder
* Major Depressive Disorders
* Posttraumatic disorder
* Other anxiety disorders

* 21 years or older;
* English-speaking;
* Daily smoker (at least 10 cigarettes/day);
* At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support;
* Not currently interested in quitting.

Exclusion Criteria

* Currently residing in a nursing home;
* Current diagnosis of Asthma;
* Cognitive impairment (score \<26 on the Telephone Interview for Cognitive Status (TICS);
* Current use of e-cigarettes (\>once a week);
* Psychiatric instability (hospitalized in the past month);
* Current AND moderate to severe substance use disorder;
* Pregnant or planning to become pregnant;
* Use of any smoked products other than cigarettes;
* Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer);
* Participation in SWITCH IT pilot study.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No