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Completed

NCT Number: NCT04737772

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Marijuana Use Mental Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optum

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral: Quitline treatment as usual

Behavioral

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)

Behavioral

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).

Primary outcomes

  1. 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)

  2. Tobacco Use

    Time frame: 3 months

    Cessation from tobacco use 7-day point prevalent abstinence

  3. 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.

  4. 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?"

Secondary outcomes

  1. Biochemical Verification of Tobacco Abstinence

    Time frame: 3 months

    Self-administered test of biochemical verification (saliva test) will be sent to participants who self-report tobacco abstinence at 3 month outcomes.

  2. Marijuana Use

    Time frame: 3 months

    Number of days used in the past 30

Sponsors and collaborators

Lead sponsor

Consumer Wellness Solutions

Industry

Collaborators

  • SRI International
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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