NCT05014282

Brief Summary

This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
638

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2021Sep 2026

First Submitted

Initial submission to the registry

August 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2026

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

August 13, 2021

Last Update Submit

February 5, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Self Reported 7 Day Abstinence Smoking Status

    Participants will self report 7-day abstinence smoking status

    12 Month Follow-Up

Secondary Outcomes (4)

  • Smoking Status by Saliva Cotinine Kit

    12 Month Follow-Up

  • Self Reported 24 Hours Smoking Abstinence

    12 Month Follow-Up

  • 30 Day Smoking Abstinence

    12 Month Follow-Up

  • Continuous Smoking Abstinence

    12 Month Follow-Up

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.

Drug: Nicotine patchBehavioral: CounselingDrug: Nicotine lozenge

Automated Treatment

EXPERIMENTAL

Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content

Drug: Nicotine patchDrug: Nicotine lozengeBehavioral: Smartphone-delivered automated treatment

Interventions

Nicotine patchDRUG

Participants will be provided with a 10-week supply of nicotine patches

Automated TreatmentStandard Treatment
CounselingBEHAVIORAL

Phone counseling with the state tobacco quitline.

Standard Treatment
Nicotine lozengeDRUG

Participants will be provided with a 10-week supply of nicotine lozenges

Automated TreatmentStandard Treatment
Smartphone-delivered automated treatmentBEHAVIORAL

An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant

Automated Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoked \>/=100 cigarettes in lifetime
  • English or Spanish speaking
  • Currently smoke \> 5 cigarettes/day
  • Willing to make a quit attempt within 1 week of enrollment
  • HIV positive
  • Process a smartphone compatible with the project app
  • Have a valid email address

You may not qualify if:

  • Currently pregnant or breastfeeding
  • Current use of smoking cessation medications
  • Enrolled in a smoking cessation study
  • Household member enrolled in the study
  • Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Vidrine DJ, Bui TC, Businelle MS, Shih YT, Sutton SK, Shahani L, Hoover DS, Bowles K, Vidrine JI. Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183.

    PMID: 34787590DERIVED

Related Links

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation DevicesCounseling

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Damon J Vidrine, Dr.PH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 20, 2021

Study Start

December 15, 2021

Primary Completion

September 23, 2025

Study Completion (Estimated)

September 23, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)