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Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification

NCT05440721 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-01

No results posted yet for this study

Summary

This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.

Conditions

  • Nicotine Addiction
  • Drug Addiction
  • Drug Dependence
  • Substance Use Disorder
  • Tobacco Dependence

Interventions

DEVICE

Treatment A with device Clickotine® (Active intervention)

The intervention regimen around Treatment A is almost entirely user-directed. When a person has a craving, a series of options are available to ease the craving and resist the urge to smoke. The user will also engage with Clickotine® leading up to their quit date to complete a program of 21 Missions, daily activities which help prepare them to quit and keep them off cigarettes. Ideally, the user will open and use Treatment A several times a day.

DEVICE

Treatment B with smoking education (control)

The Treatment B app is operated by the National Cancer Institute to provide education and support to smokers seeking to quit. The QG regimen is entirely user-directed. When a user has a craving or wants support or education, they can log into the QG app. The QG app also provides lessons relevant for preparing to quit and beginning to quit.

Sponsors & Collaborators

  • Click Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Shaheen Lakhan, MDPhD, FAAN · Click Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2022-07-31
Completion
2022-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440721 on ClinicalTrials.gov