NCT05014282

Brief Summary

This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

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

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

Completed
2 days until next milestone

Results Posted

Study results publicly available

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

3.8 years

First QC Date

August 13, 2021

Results QC Date

September 1, 2026

Last Update Submit

September 1, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Self-Reported 7-Day Point-Prevalence Smoking Abstinence

    Participants who reported no smoking, not even a puff, within the past 7 days.

    12 Month Follow-Up

Secondary Outcomes (3)

  • Biochemical Verification Via Salivary Cotinine

    12 Month Follow-Up

  • Self Reported 24 Hours Smoking Abstinence

    12 Month Follow-Up

  • Self-Reported 30-Day Point-Prevalence Smoking Abstinence

    12 Month Follow-Up

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment.

Drug: Nicotine patchBehavioral: CounselingDrug: Nicotine lozenge

Automated Treatment

EXPERIMENTAL

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

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

Interventions

Nicotine patchDRUG

Participants were 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 were provided with a 10-week supply of nicotine lozenges.

Automated TreatmentStandard Treatment
Smartphone-delivered automated treatmentBEHAVIORAL

An interactive smartphone-based intervention that comprised content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants.

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

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

Results Point of Contact

Title
Dr. Damon Vidrine
Organization
Moffitt Cancer Center
Damon.Vidrine@moffitt.org
813-745-7937

Study Officials

  • Damon J Vidrine, Dr.PH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

September 23, 2026

Last Updated

September 25, 2026

Results First Posted

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)