SmokingTALKNCT02421991
Telephone-Delivered Interventions for Smoking Cessation
A study testing Telephone Delivered Intervention in people with Smoking, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Telephone Delivered Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,275 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2015to 31 Dec 2019
- Phase
- Interventional
- 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
- ages 18 and older
- smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months
- wants to quit smoking in the next 30 days
- if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days
- willing to be randomly assigned to either group
- willing and able to speak and read in English
Show all 10Show fewer
- willing and medically eligible to use NRT
- resides in the U.S., and expects to continue for at least 12 months
- not participating in other smoking cessation interventions (including our own intervention trials)
- has regular access to a telephone.
Who cannot join
- The exclusion criteria are opposite of the inclusion criteria listed above.
- In addition we will exclude:
- anyone who is pregnant or breast feeding
- has had a heart attack in the past 30 days
- has unstable angina
- has evidence of arrhythmia in the past 6 months
- has a history of severe skin reaction to adhesive patches.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).
- Conditions
- Smoking
- Being tested
- Telephone Delivered Intervention
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Delivered InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| TALK study group | Experimental | This is the experimental arm of the study. This includes 5 weekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study. Receives: Behavioral: Telephone Delivered Intervention |
| TALK control group | Active comparator | This is the control arm of the study. This includes 5 weekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study. Receives: Behavioral: Telephone Delivered Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day point prevalence abstinence
No smoking in the past 30 days, as reported at 12 month post treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start2 Nov 2015
- Primary completion8 Aug 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Consumer Wellness Solutions, National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan B Bricker, Ph.D., Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421991
- Sponsor's protocol ID
- 8298
- Other IDs
- NCI-2018-02635, RG1001154, R01DA038411, P30CA015704
- Acronym
- TALK
- Status last verified
- Nov 2019
- First submitted
- 16 Apr 2015
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PubMed 35420700
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Delivered Interventions for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02421991
- Acronym / sponsor ID
- TALK / 8298
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Consumer Wellness Solutions, National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI)
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TALK study group | Experimental | Behavioral: Telephone Delivered InterventionThis is the experimental arm of the study. This includes 5 weekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study. |
| TALK control group | Active comparator | Behavioral: Telephone Delivered InterventionThis is the control arm of the study. This includes 5 weekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ages 18 and older
- smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months
- wants to quit smoking in the next 30 days
- if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days
- willing to be randomly assigned to either group
Key exclusion criteria (7 listed)
- The exclusion criteria are opposite of the inclusion criteria listed above.
- anyone who is pregnant or breast feeding
- has had a heart attack in the past 30 days
- has unstable angina
- has evidence of arrhythmia in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Delivered Intervention | Behavioural | TALK control group, TALK study group |
Primary outcome
30 day point prevalence abstinence
Time frame: 12 months
No smoking in the past 30 days, as reported at 12 month post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Derived from this study: PubMed 35420700Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan B Bricker, Ph.D. principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Delivered Intervention in people with Smoking, run by Fred Hutchinson 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 10 inclusion and 7 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 21 Jan 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.
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?
30 day point prevalence abstinence (time frame: 12 months). 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 NCT02421991, which also lists 1 linked publication.
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 21 Jan 2020.