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

NCT04737772 | Completed Results

• 1 other identifier: R34DA051051
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Marijuana Use

Keywords

smoking cessation; marijuana use

Outcome Measures

Primary Outcomes (4)

• 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. 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.

  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?"

  3 months

Secondary Outcomes (2)

• Biochemical Verification of Tobacco Abstinence

  3 months

• Marijuana Use

  3 months

Study Arms (2)

Standard Quitline Treatment As Usual (TAU)

ACTIVE COMPARATOR

State quitline treatment as usual

Behavioral: Behavioral: Quitline treatment as usual

QL Marijuana Check-Up intervention (QL-MJCU).

EXPERIMENTAL

Newly developed intervention for co-users of marijuana and tobacco.

Behavioral: QL Marijuana Check-Up intervention (QL-MJCU)

Interventions

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.

Standard Quitline Treatment As Usual (TAU)

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).

QL Marijuana Check-Up intervention (QL-MJCU).

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consumer Wellness Solutions: lead
• University of Washington: collaborator
• SRI International: collaborator

Study Sites (1)

Optum

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 38873657 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Marijuana Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Mental Disorders

Results Point of Contact

• Title: Helena Berlin
• Organization: RVO Health

hberlin@rvohealth.com

702-620-4965

Study Officials

• Kelly M Carpenter, PhD

  Consumer Wellness Solutions (Optum)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single arm pilot followed by a 2 arm randomized control trial

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 4, 2021
• Study Start: April 13, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)