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

Primary Purpose

Smoking Cessation, Marijuana Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Quitline treatment as usual
QL Marijuana Check-Up intervention (QL-MJCU)
Sponsored by
Consumer Wellness Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring smoking cessation, marijuana use

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • OptumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Quitline Treatment As Usual (TAU)

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

Arm Description

State quitline treatment as usual

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

Outcomes

Primary Outcome Measures

Number of calls completed
Number of calls completed (collected during treatment and finalized at end of study)
Tobacco use
Cessation from tobacco use 7-day point prevalent abstinence
Satisfaction with treatments
Satisfaction with treatments elicited via outcome survey questions
Readiness to change marijuana use
1-10 scale, where 1 signifies low readiness

Secondary Outcome Measures

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.
Marijuana use
Number of days used in the past 30

Full Information

First Posted
January 12, 2021
Last Updated
November 3, 2022
Sponsor
Consumer Wellness Solutions
Collaborators
University of Washington, SRI International
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1. Study Identification

Unique Protocol Identification Number
NCT04737772
Brief Title
Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco
Official Title
A Brief Behavioral Intervention for Co-users of Marijuana (MJ) and Tobacco Among Smokers Calling State Quitlines
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consumer Wellness Solutions
Collaborators
University of Washington, SRI International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Marijuana Use
Keywords
smoking cessation, marijuana use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single arm pilot followed by a 2 arm randomized control trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Quitline Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm Description
State quitline treatment as usual
Arm Title
QL Marijuana Check-Up intervention (QL-MJCU).
Arm Type
Experimental
Arm Description
Newly developed intervention for co-users of marijuana and tobacco.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Quitline treatment as usual
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
QL Marijuana Check-Up intervention (QL-MJCU)
Intervention Description
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 Outcome Measure Information:
Title
Number of calls completed
Description
Number of calls completed (collected during treatment and finalized at end of study)
Time Frame
from program enrollment up to 3 months post-enrollment
Title
Tobacco use
Description
Cessation from tobacco use 7-day point prevalent abstinence
Time Frame
3 months
Title
Satisfaction with treatments
Description
Satisfaction with treatments elicited via outcome survey questions
Time Frame
3 months
Title
Readiness to change marijuana use
Description
1-10 scale, where 1 signifies low readiness
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Biochemical Verification of Tobacco Abstinence
Description
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
Title
Marijuana use
Description
Number of days used in the past 30
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alula Torres, MPH
Phone
469-608-4204
Email
alula.torres@optum.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly M Carpenter, PhD
Organizational Affiliation
Consumer Wellness Solutions (Optum)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optum
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alula Torres, MPH
Email
alula.torres@optum.com
First Name & Middle Initial & Last Name & Degree
Kelly Carpenter
Email
kelly.carpenter@optum.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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