Cessation Clinical Trial

Truth Initiative

Status: Active, not recruiting

Conditions: Tobacco Use Cessation

Treatments: Behavioral: Usual Care; Behavioral: Truth Initiative Digital Cessation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06806098

CessationClinicalTrial

Details and patient eligibility

About

The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.

Enrollment: 2,220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Current tobacco use (past 30-day use of one or more of the following: cigarettes, cigars, little cigars, cigarillos, e-cigarettes, or oral nicotine products)
• US residence
• Active text message plan (phase 2 only)

Exclusion criteria

• Age 25 or above (phase 2 only)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,220 participants in 4 patient groups

Sponsored cessation intervention

Experimental group

Description:

Intervention arm receiving sponsored version only available for enterprise client users.

Treatment:

Behavioral: Truth Initiative Digital Cessation Program

Usual Care

Active Comparator group

Description:

Usual care control arm receiving referral to a free digital cessation program

Treatment:

Behavioral: Usual Care

Free cessation intervention

Experimental group

Description:

Intervention arm receiving free version of a cessation intervention.

Treatment:

Behavioral: Truth Initiative Digital Cessation Program

Assessment-only

No Intervention group

Description:

Periodic assessment check-ins only, no active intervention