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

Study Overview
=================
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.

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

Conditions
-----------------
Smoking Cessation, Marijuana Use

Intervention / Treatment
-----------------
* Behavioral: Behavioral: Quitline treatment as usual
* Behavioral: QL Marijuana Check-Up intervention (QL-MJCU)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single arm pilot followed by a 2 arm randomized control trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Quitline Treatment As Usual (TAU)<br>State quitline treatment as usual | Behavioral: Behavioral: Quitline treatment as usual<br>* 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.<br>|
| Experimental: QL Marijuana Check-Up intervention (QL-MJCU).<br>Newly developed intervention for co-users of marijuana and tobacco. | Behavioral: QL Marijuana Check-Up intervention (QL-MJCU)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of calls completed | Number of calls completed (collected during treatment and finalized at end of study) | from program enrollment up to 3 months post-enrollment | 
| Tobacco use | Cessation from tobacco use 7-day point prevalent abstinence | 3 months | 
| Satisfaction with treatments | Satisfaction with treatments elicited via outcome survey questions | 3 months | 
| Readiness to change marijuana use | 1-10 scale, where 1 signifies low readiness | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| Marijuana use | Number of days used in the past 30 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, marijuana use