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Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco

A Brief Behavioral Intervention for Co-users of Marijuana (MJ) and Tobacco Among Smokers Calling State Quitlines

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04737772
Enrollment
107
Registered
2021-02-04
Start date
2021-04-13
Completion date
2022-12-01
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Use, Smoking Cessation

Keywords

smoking cessation, marijuana use

Brief 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. 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.

Interventions

BEHAVIORALBehavioral: Quitline treatment as usual

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.

BEHAVIORALQL 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).

Sponsors

University of Washington
CollaboratorOTHER
SRI International
CollaboratorINDUSTRY
Consumer Wellness Solutions
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

A single arm pilot followed by a 2 arm randomized control trial

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Calls Completedfrom program enrollment up to 3 months post-enrollmentNumber of calls completed (collected during treatment and finalized at end of study)
Tobacco Use3 monthsCessation from tobacco use 7-day point prevalent abstinence
Satisfaction With Treatments3 monthsSatisfaction 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 Use3 months1-10 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?

Secondary

MeasureTime frameDescription
Biochemical Verification of Tobacco Abstinence3 monthsSelf-administered test of biochemical verification (saliva test) will be sent to participants who self-report tobacco abstinence at 3 month outcomes.
Marijuana Use3 monthsNumber of days used in the past 30

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Quitline Treatment As Usual (TAU)
State quitline treatment as usual Behavioral: Quitline treatment as usual: 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.
49
QL Marijuana Check-Up Intervention (QL-MJCU).
Newly developed intervention for co-users of marijuana and tobacco. 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).
53
Total102

Withdrawals & dropouts

PeriodReasonFG000FG001
Phase 2 StudyDid not take any coaching calls40
Phase 2 StudyLost to Follow-up1515
Phase 2 StudyWithdrawal by Subject01
Pilot Phase 1 of StudyRandomized but ineligible01
Pilot Phase 1 of StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicStandard Quitline Treatment As Usual (TAU)TotalQL Marijuana Check-Up Intervention (QL-MJCU).
Age, Continuous50.4 Years
STANDARD_DEVIATION 14.3
51.7 Years
STANDARD_DEVIATION 13.6
52.9 Years
STANDARD_DEVIATION 13
Cannabis Use Disorder Identification Test10.2 units on a scale
STANDARD_DEVIATION 4.9
10.1 units on a scale
STANDARD_DEVIATION 4.7
10.1 units on a scale
STANDARD_DEVIATION 4.4
Cigarettes Per Day17.4 number of cigarettes per day
STANDARD_DEVIATION 8.1
16.3 number of cigarettes per day
STANDARD_DEVIATION 7.7
15.2 number of cigarettes per day
STANDARD_DEVIATION 7.2
Daily Cannabis Use (20+ Days in Last 30 Days)41 Participants80 Participants39 Participants
Days of Cannabis Use Within Last 30 Days25.7 Days
STANDARD_DEVIATION 6.8
24.8 Days
STANDARD_DEVIATION 7.1
24.0 Days
STANDARD_DEVIATION 7.4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants100 Participants51 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Poitive Screening for Depression (PHQ-2)20 Participants34 Participants14 Participants
POsitive Screening for Anxiety (GAD-2)20 Participants34 Participants14 Participants
PSS-46.8 units on a scale
STANDARD_DEVIATION 3.5
6.2 units on a scale
STANDARD_DEVIATION 3.2
5.7 units on a scale
STANDARD_DEVIATION 2.7
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants16 Participants9 Participants
Race (NIH/OMB)
More than one race
3 Participants8 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
37 Participants75 Participants38 Participants
Readiness to Quit Cannabis3.4 units on a scale
STANDARD_DEVIATION 3.2
3.3 units on a scale
STANDARD_DEVIATION 3.2
3.3 units on a scale
STANDARD_DEVIATION 3.2
Readiness to Reduce Cannabis4.2 units on a scale
STANDARD_DEVIATION 3.3
4.2 units on a scale
STANDARD_DEVIATION 3.3
4.1 units on a scale
STANDARD_DEVIATION 3.3
Region of Enrollment
United States
49 participants102 participants53 participants
Sex: Female, Male
Female
25 Participants51 Participants26 Participants
Sex: Female, Male
Male
24 Participants51 Participants27 Participants
Time to First Cigarette Use
31-60 Minutes
7 Participants13 Participants6 Participants
Time to First Cigarette Use
6-30 minutes
26 Participants48 Participants22 Participants
Time to First Cigarette Use
More than 60 Minutes
2 Participants7 Participants5 Participants
Time to First Cigarette Use
Within 5 Minutes
14 Participants34 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Number of Calls Completed

Number of calls completed (collected during treatment and finalized at end of study)

Time frame: from program enrollment up to 3 months post-enrollment

Population: 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed

ArmMeasureValue (NUMBER)
Standard Quitline Treatment As Usual (TAU)Number of Calls Completed123 Total number of calls
QL Marijuana Check-Up Intervention (QL-MJCU).Number of Calls Completed141 Total number of calls
Primary

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?

Time frame: 3 months

Population: 4 TAU participants did not take any program calls and 1 QJ-MJCU participant withdrew from the study. Their outcomes data were not collected. 15 participants in each group were lost to follow-up and questions were not required to be answered.

ArmMeasureValue (MEAN)Dispersion
Standard Quitline Treatment As Usual (TAU)Readiness to Change Marijuana Use3.3 units on a scaleStandard Deviation 3.4
QL Marijuana Check-Up Intervention (QL-MJCU).Readiness to Change Marijuana Use2.9 units on a scaleStandard Deviation 2.9
Primary

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.

Time frame: 3 months

Population: 4 TAU participants did not take any program calls and 1 QJ-MJCU participant withdrew from the study. Their outcomes data were not collected. 15 participants in each group were lost to follow-up and questions were not required to be answered.

ArmMeasureValue (NUMBER)
Standard Quitline Treatment As Usual (TAU)Satisfaction With Treatments28 participants
QL Marijuana Check-Up Intervention (QL-MJCU).Satisfaction With Treatments30 participants
Primary

Tobacco Use

Cessation from tobacco use 7-day point prevalent abstinence

Time frame: 3 months

Population: 4 TAU participants did not receive coaching calls and 1 QL-MJCU participant withdrew from the study; therefore their outcomes data were not analyzed

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Quitline Treatment As Usual (TAU)Tobacco Use14 Participants
QL Marijuana Check-Up Intervention (QL-MJCU).Tobacco Use13 Participants
Secondary

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.

Time frame: 3 months

Population: Twenty-seven participants reported being quit from tobacco at their follow-up and were mailed a cotinine test kit. Ten of those participants returned results via an emailed photo of their results strip

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Quitline Treatment As Usual (TAU)Biochemical Verification of Tobacco Abstinence2 Participants
QL Marijuana Check-Up Intervention (QL-MJCU).Biochemical Verification of Tobacco Abstinence5 Participants
Secondary

Marijuana Use

Number of days used in the past 30

Time frame: 3 months

Population: 4 TAU participants did not take any program calls and 1 QJ-MJCU participant withdrew from the study. Their outcomes data were not collected. 15 participants in each group were lost to follow-up and questions were not required to be answered.

ArmMeasureValue (MEAN)Dispersion
Standard Quitline Treatment As Usual (TAU)Marijuana Use23.2 daysStandard Deviation 10
QL Marijuana Check-Up Intervention (QL-MJCU).Marijuana Use19.1 daysStandard Deviation 11.8

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026