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

November 3, 2022 updated by: Consumer Wellness Solutions

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Quitline Treatment As Usual (TAU)
State 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.
Experimental: QL Marijuana Check-Up intervention (QL-MJCU).
Newly developed intervention for co-users of marijuana and tobacco.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
from program enrollment up to 3 months post-enrollment
Tobacco use
Time Frame: 3 months
Cessation from tobacco use 7-day point prevalent abstinence
3 months
Satisfaction with treatments
Time Frame: 3 months
Satisfaction with treatments elicited via outcome survey questions
3 months
Readiness to change marijuana use
Time Frame: 3 months
1-10 scale, where 1 signifies low readiness
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kelly M Carpenter, PhD, Consumer Wellness Solutions (Optum)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • R34DA051051 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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