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Smoking CessationEarly Phase 1NCT03290430

End Nicotine Dependence Clinic

A Early Phase 1 study testing Group Counseling, Individual Counseling and Phone Counseling in people with Smoking Cessation, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Group Counseling, Individual Counseling and Phone Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
9 Jan 2018to 6 Jan 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a breath carbon monoxide (CO) reading of ≥ 8 ppm)
  • Able to speak and read English
  • Able to engage using at least one of the intervention formats.

Who cannot join

  • Enrollment in another cessation program
  • Do not speak and read English
  • Do not have access to at least one intervention format
  • Have contraindications for NRT
  • Do not have contact information (e.g., address, telephone number)
  • Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse)
  • They endorse active addiction to another substance (e.g., illicit drugs or alcohol).
  • People who self-report having a severe mental illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Western Reserve University, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: End Nicotine Dependence (END) Clinic

The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.

Read the detailed description

Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the opportunity to receive a CBT-based tobacco intervention delivered several possible formats (face-to-face, telephone, video-counseling) based on availability and participant preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse prevention strategies, and discuss barriers to cessation, previous quit attempts, risky situations, and benefits observed after quitting. Participants may also complete exercises designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine replacement therapy and text-messaging support.

Objective 2: To examine the rates of smoking abstinence across intervention formats. Investigators will attempt to follow-up with participants for a 6-months after program completion. Investigators will assess point prevalence abstinence for each intervention delivery method.

Objective 3: To assess individual difference variables that influence outcomes. Investigators will examine individual-difference predictors of outcomes, such as readiness to quit, social support, distress, and environmental factors.

Being tested
Group Counseling, Individual Counseling, Phone Counseling, Video Counseling, Texting support
Keywords
Nicotine Dependence, applied behavioral research
Medical subject headings
Smoking Cessation, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group CounselingBehavioural

    8 sessions over 4 weeks. Lasting 1-2 hours each

  • Individual CounselingBehavioural

    8 in person sessions over 4 weeks. Lasting 30-45 minutes each

  • Phone CounselingBehavioural

    8 phone sessions over 4 weeks. Lasting 30-45 minutes each

  • Video CounselingBehavioural

    8 video call sessions over 4 weeks. Lasting 30-45 minutes each

  • Texting supportBehavioural

    Texts with smoking cessation support throughout the program

  • Nicotine Replacement TherapyDrug

    Also called Nicotine Patch, Nicotine Gum, NRT

    Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy

Study groups in NCT03290430
Study groupRoleWhat they receive
Group CounselingExperimentalParticipants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 1-2 hours. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
Receives: Behavioral: Group Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy
Individual CounselingExperimentalParticipants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 30-45 minutes. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
Receives: Behavioral: Individual Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy
Telephone CounselingExperimentalParticipants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 phone calls over 4 week, each lasting between 30-45 minutes. During these phone calls, participants will learn about how to quit smoking by changing habits. Sessions may be audio taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
Receives: Behavioral: Phone Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy
Video CounselingExperimentalParticipants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 video calls over 4 week, each lasting between 30-45 minutes. During these video calls, participants will learn about how to quit smoking by changing habits. Sessions may be recorded. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
Receives: Behavioral: Video Counseling; Behavioral: Texting support; Drug: Nicotine Replacement Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of 24 hour smoking abstinence across intervention

    Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking)

    Measured: Up to 24 hours after session 1

Secondary outcomes (6)

  1. Rate of 7-day smoking abstinence across intervention

    Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking)

    Measured: Up to 7 days after session 1

  2. Rate of 28-day smoking abstinence across intervention

    Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking)

    Measured: Up to 28 days after session 1

  3. Average intervention rating

    Scaled survey will be used to assess the quality and the content of the intervention [i.e., the extent to which the content was informative, encouraging, attention capturing, credible, applicable to their lives, and comprehensible.]

    Measured: Up to 4 weeks after session 1

  4. Sessions completed

    Average count of sessions each participant completed (1-8)

    Measured: Up to 4 weeks after session 1

  5. Study Retention

    Measured: Up to 4 weeks after session 1

  6. Nicotine Replacement Therapy (NRT) Completed

    Average count of doses of NRT taken by participants

    Measured: Up to 4 weeks after session 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start9 Jan 2018
  3. Primary completion6 Dec 2019
  4. Study completion6 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03290430
Sponsor's protocol ID
CASE3Z17
Status last verified
Apr 2020
First submitted
19 Sep 2017
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Group Counseling, Individual Counseling and Phone Counseling in people with Smoking Cessation, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of 24 hour smoking abstinence across intervention (time frame: Up to 24 hours after session 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03290430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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End Nicotine Dependence Clinic (NCT03290430) | AzTrials