Smoking CessationNCT04737772
Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco
A study testing Behavioral: Quitline treatment as usual and QL Marijuana Check-Up intervention (QL-MJCU) in people with Smoking Cessation and Marijuana Use, run by Consumer Wellness Solutions at 1 site in United States.
Trial summary
Smoking cigarettes remains the number one preventable cause of death and disease in the US. Smokers who call tobacco quitlines and use marijuana struggle to quit tobacco due to the interactive effects of nicotine and marijuana. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Marijuana Use
- What is being tested?
- Behavioral: Quitline treatment as usual and QL Marijuana Check-Up intervention (QL-MJCU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- daily use of 5 or more tobacco cigarettes
- aged 21 and older
- recruited from participating state quitlines (AK, DC, OR, WA)
- provides an email address
- wants to quit tobacco in the next 30 days
- used cannabis on 9 or more days in the past 30 days
Who cannot join
- unable to speak and read English
- have limited access to a telephone
- pregnant or post-partum (because they are not offered the standard QL program)
- self-reported schizophrenia
- all cannabis use is recommended by a doctor or other healthcare professional
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Behavioral Intervention for Co-users of Marijuana (MJ) and Tobacco Among Smokers Calling State Quitlines
Smoking cigarettes remains the number one preventable cause of death and disease in the US. Smokers who call tobacco quitlines and use marijuana struggle to quit tobacco due to the interactive effects of nicotine and marijuana. A recent study found that 25% of callers to state quitlines said they were using marijuana and 44% of those were interested in quitting or cutting back their marijuana use (in addition to wanting to quit smoking). The investigators propose to develop an integrated intervention for co-users of marijuana and tobacco to be delivered via state-funded quitlines. The investigators will incorporate key elements of an evidence-based brief behavioral intervention called 'The Marijuana Check-Up' into the tobacco quitline treatment. The investigators will evaluate the feasibility, acceptability and preliminary effects of the new intervention in a small randomized pilot study with 100 co-users recruited from four participating state quitlines. Outcomes measured at 3 months post randomization will include tobacco abstinence (biochemically verified) and days used marijuana. The investigators hypothesize that the intervention will: (1) be feasible to deliver (measured by coach treatment fidelity scores); (2) be acceptable to co-users (measured by enrollments into the study and call completion numbers); (3) increase tobacco cessation rates compared with standard quitline treatment; (4) increase co-users motivation to change MJ use; and (5) produce greater reduction in days using MJ compared with standard quitline treatment. The proposed brief behavioral intervention addressing co-use may increase quitline callers' chances of achieving and maintaining tobacco abstinence and increase participants' motivation to reduce marijuana use. As non-medicinal marijuana use becomes common and legal in more states, a low touch phone and web-based intervention for co-users of marijuana and tobacco could improve health outcomes for many. Findings will inform development of scalable public health intervention strategies for co-users easily implemented across quitlines.
Read the detailed description
We proposed to adapt a brief motivational intervention for cannabis (CB)) users who call tobacco quitlines for help quitting tobacco. We plan to recruit 100 adult co-users of tobacco and CB from four state quitlines that have legalized non-medicinal CB user. Quitline registration staff screen participants for current use of CB and interest in learning about CB use. Interested co-users will then talk to a specially trained quit coach who will ask additional eligibility questions, obtain informed consent from eligible participants, conduct a baseline assessment, randomize individuals to one of two groups and deliver the first counseling session according to the assigned intervention. Randomization is automated using the pre-programmed random number table (stratified by state and gender) built into the Quitline coaching application. Individuals are randomly assigned to receive the standard Quitline or the integrated CB and quitline intervention. All participants receive the standard quitline treatment: 4-5 counseling sessions delivered over the phone, mailed materials, access to the text messaging and web-based program plus cessation medications (nicotine replacement therapy; NRT) and unlimited calls into the quitline for help between calls. Quit coaches will deliver the CB intervention during the tobacco quitline calls for the intervention group. Study participants complete surveys at baseline and 3-months. We will compare groups on treatment engagement (calls completed) and outcomes at 3 months (tobacco abstinence and change in days used CB). Our proposed sample size of 100 (50 per group) is sufficient to achieve our study aims of assessing the feasibility, acceptability and preliminary effectiveness of the new integrated intervention compared with standard quitline treatment.
- Conditions
- Smoking Cessation, Marijuana Use
- Being tested
- Behavioral: Quitline treatment as usual, QL Marijuana Check-Up intervention (QL-MJCU)
- Keywords
- smoking cessation, marijuana use
- Medical subject headings
- Smoking Cessation, Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Quitline treatment as usualBehavioural
TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
QL Marijuana Check-Up intervention (QL-MJCU)Behavioural
QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
| Study group | Role | What they receive |
|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Active comparator | State quitline treatment as usual Receives: Behavioral: Behavioral: Quitline treatment as usual |
| QL Marijuana Check-Up intervention (QL-MJCU). | Experimental | Newly developed intervention for co-users of marijuana and tobacco. Receives: Behavioral: QL Marijuana Check-Up intervention (QL-MJCU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Calls Completed
Number of calls completed (collected during treatment and finalized at end of study)
Measured: from program enrollment up to 3 months post-enrollment
Tobacco Use
Cessation from tobacco use 7-day point prevalent abstinence
Measured: 3 months
Satisfaction With Treatments
Satisfaction with treatments elicited via outcome survey questions. Question asked, "Overall, how satisfied were you with the Quitline? Would you say…" Answer responses were: VERY SATISFIED; SATISFIED; SOMEWHAT SATISFIED; SOMEWHAT DISSATISFIED; DISSATISFIED; VERY DISSATISFIED; I PREFER NOT TO ANSWER. The outcome measure reported the number of those who responded as being somewhat satisfied or higher.
Measured: 3 months
Readiness to Change Marijuana Use
1-10 scale, where 1 signifies low readiness. On the 3-months post-outcomes survey participants were asked: "On a scale of 1 to 10 where 1 is not at all ready and 10 is very ready, how ready are you to reduce how much cannabis you use?"
Measured: 3 months
Secondary outcomes (2)
Biochemical Verification of Tobacco Abstinence
Self-administered test of biochemical verification (saliva test) will be sent to participants who self-report tobacco abstinence at 3 month outcomes.
Measured: 3 months
Marijuana Use
Number of days used in the past 30
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start13 Apr 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Model description
- A single arm pilot followed by a 2 arm randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, SRI International
- Responsible party
- Sponsor
- Investigators
- Kelly M Carpenter, PhD, Principal investigator, Consumer Wellness Solutions (Optum)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737772
- Sponsor's protocol ID
- R34DA051051
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2021
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpenter KM, Walker DD, Mullis K, Berlin HM, Short E, Javitz HS, Carlini BH. Testing a Brief Quitline Intervention for Tobacco Cannabis Co-Users: A Randomized Controlled Pilot Study. Tob Use Insights. 2024 Jun 12;17:1179173X241261302. doi: 10.1177/1179173X241261302. eCollection 2024.
PubMed 38873657
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Behavioral Intervention for Co-users of Marijuana (MJ) and Tobacco Among Smokers Calling State Quitlines
- ClinicalTrials.gov ID
- NCT04737772
- Acronym / sponsor ID
- R34DA051051
- Conditions
- Smoking Cessation, Marijuana Use
- Keywords
- smoking cessation, marijuana use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington, SRI International
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking cigarettes remains the number one preventable cause of death and disease in the US. Smokers who call tobacco quitlines and use marijuana struggle to quit tobacco due to the interactive effects of nicotine and marijuana. A recent study found that 25% of callers to state quitlines said they were using marijuana and 44% of those were interested in quitting or cutting back their marijuana use (in addition to wanting to quit smoking). The investigators propose to develop an integrated intervention for co-users of marijuana and tobacco to be delivered via state-funded quitlines. The investigators will incorporate key elements of an evidence-based brief behavioral intervention called 'The Marijuana Check-Up' into the tobacco quitline treatment. The investigators will evaluate the feasibility, acceptability and preliminary effects of the new intervention in a small randomized pilot study with 100 co-users recruited from four participating state quitlines. Outcomes measured at 3 months post randomization will include tobacco abstinence (biochemically verified) and days used marijuana. The investigators hypothesize that the intervention will: (1) be feasible to deliver (measured by coach treatment fidelity scores); (2) be acceptable to co-users (measured by enrollments into the study and call completion numbers); (3) increase tobacco cessation rates compared with standard quitline treatment; (4) increase co-users motivation to change MJ use; and (5) produce greater reduction in days using MJ compared with standard quitline treatment. The proposed brief behavioral intervention addressing co-use may increase quitline callers' chances of achieving and maintaining tobacco abstinence and increase participants' motivation to reduce marijuana use. As non-medicinal marijuana use becomes common and legal in more states, a low touch phone and web-based intervention for co-users of marijuana and tobacco could improve health outcomes for many. Findings will inform development of scalable public health intervention strategies for co-users easily implemented across quitlines.
Detailed description
We proposed to adapt a brief motivational intervention for cannabis (CB)) users who call tobacco quitlines for help quitting tobacco. We plan to recruit 100 adult co-users of tobacco and CB from four state quitlines that have legalized non-medicinal CB user. Quitline registration staff screen participants for current use of CB and interest in learning about CB use. Interested co-users will then talk to a specially trained quit coach who will ask additional eligibility questions, obtain informed consent from eligible participants, conduct a baseline assessment, randomize individuals to one of two groups and deliver the first counseling session according to the assigned intervention. Randomization is automated using the pre-programmed random number table (stratified by state and gender) built into the Quitline coaching application. Individuals are randomly assigned to receive the standard Quitline or the integrated CB and quitline intervention. All participants receive the standard quitline treatment: 4-5 counseling sessions delivered over the phone, mailed materials, access to the text messaging and web-based program plus cessation medications (nicotine replacement therapy; NRT) and unlimited calls into the quitline for help between calls. Quit coaches will deliver the CB intervention during the tobacco quitline calls for the intervention group. Study participants complete surveys at baseline and 3-months. We will compare groups on treatment engagement (calls completed) and outcomes at 3 months (tobacco abstinence and change in days used CB). Our proposed sample size of 100 (50 per group) is sufficient to achieve our study aims of assessing the feasibility, acceptability and preliminary effectiveness of the new integrated intervention compared with standard quitline treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single arm pilot followed by a 2 arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Standard Quitline Treatment As Usual (TAU) | Active comparator | Behavioral: Behavioral: Quitline treatment as usualState quitline treatment as usual |
| QL Marijuana Check-Up intervention (QL-MJCU). | Experimental | Behavioral: QL Marijuana Check-Up intervention (QL-MJCU)Newly developed intervention for co-users of marijuana and tobacco. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- daily use of 5 or more tobacco cigarettes
- aged 21 and older
- recruited from participating state quitlines (AK, DC, OR, WA)
- provides an email address
- wants to quit tobacco in the next 30 days
Key exclusion criteria (5 listed)
- unable to speak and read English
- have limited access to a telephone
- pregnant or post-partum (because they are not offered the standard QL program)
- self-reported schizophrenia
- all cannabis use is recommended by a doctor or other healthcare professional
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 |
|---|---|---|
| Behavioral: Quitline treatment as usualTAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions. | Behavioural | Standard Quitline Treatment As Usual (TAU) |
| QL Marijuana Check-Up intervention (QL-MJCU)QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR). | Behavioural | QL Marijuana Check-Up intervention (QL-MJCU). |
Primary outcome
Number of Calls Completed
Time frame: from program enrollment up to 3 months post-enrollment
Number of calls completed (collected during treatment and finalized at end of study)
Tobacco Use
Time frame: 3 months
Cessation from tobacco use 7-day point prevalent abstinence
Satisfaction With Treatments
Time frame: 3 months
Satisfaction with treatments elicited via outcome survey questions. Question asked, "Overall, how satisfied were you with the Quitline? Would you say…" Answer responses were: VERY SATISFIED; SATISFIED; SOMEWHAT SATISFIED; SOMEWHAT DISSATISFIED; DISSATISFIED; VERY DISSATISFIED; I PREFER NOT TO ANSWER. The outcome measure reported the number of those who responded as being somewhat satisfied or higher.
Readiness to Change Marijuana Use
Time frame: 3 months
1-10 scale, where 1 signifies low readiness. On the 3-months post-outcomes survey participants were asked: "On a scale of 1 to 10 where 1 is not at all ready and 10 is very ready, how ready are you to reduce how much cannabis you use?"
2 secondary outcomes
Biochemical Verification of Tobacco Abstinence
Time frame: 3 months
Marijuana Use
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38873657Carpenter KM, Walker DD, Mullis K, Berlin HM, Short E, Javitz HS, Carlini BH. Testing a Brief Quitline Intervention for Tobacco Cannabis Co-Users: A Randomized Controlled Pilot Study. Tob Use Insights. 2024 Jun 12;17:1179173X241261302. doi: 10.1177/1179173X241261302. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Kelly M Carpenter, PhD principal investigator
Consumer Wellness Solutions (Optum)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Quitline treatment as usual and QL Marijuana Check-Up intervention (QL-MJCU) in people with Smoking Cessation and Marijuana Use, run by Consumer Wellness Solutions 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 6 inclusion and 5 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 27 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Calls Completed (time frame: from program enrollment up to 3 months post-enrollment). The study lists 4 primary outcomes in all. 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 NCT04737772, 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 27 Feb 2025.