Health TrialsbyHealthPanel

Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness

ConditionsTobacco CessationTobacco AbstinenceTobacco UseTobacco Use CessationTobacco Dependence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Able to understand study procedures and to comply with them for the entire length of the study.

Ability of individual to understand a written informed consent document, and the willingness to sign it.

Staying at the recruitment site and meeting criteria for homelessness as defined by the Homeless Emergency and Rapid Transition to Housing Act.

Disqualifiers

Contraindication to any study-related procedure or assessment.

Reasons that preclude the use of nicotine replacement therapy (NRT) (e.g., pregnancy or myocardial infarction in the past two weeks).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicotine Replacement Therapy (NRT)

    Drug

    NRT will be administered as patch (transdermal), gum, or lozenge

  • Wellness Coaching

    Behavioral

    Delivered via phone call

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Treatment (extended intervention for tobacco use)Experimental treatment 2 interventions
Group B: Pharm-onlyOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants who attended coaching sessions

The percentage of participants who attended at least 75% or 7 of the 14 coaching sessions will be reported.

Time frame
up to 6 months
2

Percentage of participants who used nicotine replacement therapy (NRT)

The percentage of participants who used at least 75% will adhere to using NRT for at least half of the treatment duration will be reported.

Time frame
up to 6 months
3

7-day point prevalence tobacco abstinence at month 6

Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up will be reported.

Time frame
6 months

Secondary outcomes

1

7-day point prevalence tobacco abstinence at month 3

Biochemically verified 7-day point prevalence tobacco abstinence at 3-months follow-up will be reported.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Tobacco Related Disease Research Program

Collaborator

Source ClinicalTrials.gov
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